chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine, Nasopharyngitis, Pyrexia
Clinical narrative: Approximately 12 hours later she developed a fever/feeling warm; Approximately 12 hours later she developed a fever, headache, and cold like symptoms; cold like symptoms/cold for the past 2 days; a bit of a migraine; This is a spontaneous report from a contactable consumer (patient).   A 21-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 05Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient's medical history and concomitant medications was not reported. Approximately 12 hours after vaccination in Apr2021, patient developed a fever, headache, and cold like symptoms. Patient said the first day she had no reaction to the vaccine. She said she went to sleep that night, and in the middle of the night she awoke and was feeling warm in Apr2021. She said she had a cold for the past 2 days, and a bit of a migraine, both in Apr2021. She wants to know how long these side effects could last and why do some people not experience side effects. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-1 test positive
Clinical narrative: her daughter received her first vaccine dose on April 1 and tested positive for Covid on April 6th; This is a spontaneous report from a contactable consumer (parent) via medical information team. A contactable consumer reported for her daughter.  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on 01Apr2021 at a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced her daughter received her first vaccine dose on April 1 and tested positive for covid on 06Apr2021. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Large intestine perforation
Clinical narrative: diverticulitis; perforated colon; it caused an abdominal infection and inflammation; she is still having a little bit of pain in her abdomen/she was in a lot of pain but is mostly better; This is a spontaneous report from a contactable consumer (pateint) via a Pfizer-sponsored program COVAX Support. A 40-year-old female patient received the first dose of bnt162b2, via an unspecified route of administration, administered in right arm on 17Mar2021 10:00 (Lot number was not reported) as single dose for covid-19 immunisation. The patient and concomitant medications were not reported. The patient experienced diverticulitis, perforated colon, abdominal infection and inflammation on 30Mar2021; she is still having a little bit of pain in her abdomen/she was in a lot of pain but is mostly better on an unspecified date. The patient was hospitalized for diverticulitis, perforated colon, abdominal infection and inflammation from 30Mar2021 to 01Apr2021. The all events were resulted in Emergency Room and Physician Office. Patient was due for second dose of Pfizer BioNTech Covid vaccine tomorrow (08Apr2021) but was hopitalized last week for diverticulitis and a perforated colon. She was released from the hospital last Thursday and is currently taking Metronidazole 500mg three times a day and ciprofloxacin 500mg1 tablet by mouth every 12 hours. At her follow up today (07Apr2021) the doctor was unsure of a recommendation. She lost her vaccination card. She mentioned that she will be having the 2nd dose tomorrow 08Apr2021 and she wants to know if possible since she doesn't have the card. She mentioned that she got hospitalized last week and she is under medication due to abdominal infection and she is taking antibiotics until next 2 weeks. She was in the hospital for diverticulitis and a perforated colon two nights last week and was pumped with a ton of antibiotics and is currently on antibiotics. It caused an abdominal infection and inflammation and she received five bags of antibiotics and was sent home with two different antibiotics, one for 2 weeks and one for 3 weeks. She is essentially from tomorrow to two weeks on antibiotics and didn't know if it would be an issue with getting the vaccine. She asked her family physician and he said he would probably wait because there is a chance it would counteract with the vaccine. Caller states her daughter lost her vaccination card and asks if this is going to be an issue as long as she goes to the same place she went to get her second shot, states this must have happened to other people. During that time at the hospital she had a total of five bags of antibiotics. She was still having a little bit of pain in her abdomen and probably why she was on antibiotics for two weeks. She was in a lot of pain but is mostly better. About the treatment, patient stated she was on morphine while in the hospital and they did a CT scan with dye. Patient stated all her blood work came back healthy. The outcome of the event abdominal pain was recovering, other events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: He got Covid-19 virus; This is a spontaneous report received from a contactable consumer (patient relative) via a medical information team.   A male patient of unspecified age (51 unit unspecified) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number unknown), via an unspecified route of administration, on 05Apr2021 at SINGLE DOSE for COVID-19 Immunization. Medical history and concomitant medication were not reported. It was reported, reporter Husband got his first dose of the vaccine last Monday (date unspecified). He got COVID-19 virus and she asked if he has to start all over or if he can get his second dose as scheduled on 19Apr2021. The outcome of events was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Head titubation, Peripheral swelling, Tremor
Clinical narrative: arm got swollen; shaking her head and hands; shaking her head and hands; This is a spontaneous report from a contactable consumer (parent). A 43-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation, age at vaccination unknown. The patient medical history included lennox gastaut syndrome (has a special condition) from an unspecified date. Concomitant medications were not reported. The patient experienced arm got swollen, and shaking her head and hands continuously for 5-7 minutes on Apr2021 after getting the first dose. Outcome of the events was unknown. She will get the 2nd dose on 26Apr2021.  Information on the lot/ batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Headache; Light fever after 10 hours; This is a spontaneous report from a contactable consumer. This consumer reported for a 30-year-old male patient received second dose of bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 Vaccine) via an unspecified route of administration on Mar2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 in Feb2021 for covid-19 immunization. The patient experienced headache on Mar2021 with outcome of unknown, light fever after 10 hours on Mar2021 with outcome of recovered.  Facility where the most recent COVID-19 vaccine was administered was unknown. It is unknown that the patient was receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Joint swelling
Clinical narrative: headache all night; swelling with bubbling around the wrist; This is a spontaneous report from Pfizer Sponsored  program. A contactable consumer (patient) reported a female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route single dose for COVID-19 immunization on 31Mar2021. Medical history and concomitant medication were not reported. On 31Mar2021, the patient developed a swelling with bubbling around the wrist. she stated that she was prone to hives. The swelling only lasted about 5 minutes. She had a headache all night. Outcome of the event headache was unknown; outcome of the other event was resolved on 31Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash morbilliform, Rash papular, Rash pruritic
Clinical narrative: she had a rash that looks like measles all over and she was still itchy since she started; It's a bright red rash all over her body my arm, her legs and her waist; and want to scratch the bumps and then they turn red and it has not gone away; Itchy Measle like rash all over body; This is a spontaneous report from a contactable consumer(patient). A 59-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration at Arm Right on 01-APR-2021 09:30 at the 59 years old at single dose for COVID-19 immunization.  The medical history included Asthma, Anxiety, food allergies(Penn, Kiwi fruit). The concomitant medications were alprazolam(XANAX) for Anxiety, salbutamol(PROVENTIL) for Asthma. For 2 days, the pateint felt ok and then started becoming itchy, ever since she become itchy, on 03APR2021 21:00 she had a rash that looks like measles all over and she was still itchy since she started. It never went away. It's a bright red rash all over her body her arm, her legs and her waist. It felt itchy, and want to scratch the bumps and then they turn red and it has not gone away. When told the role of the department and asked for permission to probe questions, consumer stated, "Her internal medicine doctor told her to call Pfizer and tell them an ask what to do about the rash and she need future vaccination?" The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no treatment received for all 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. About the lot number, the patient stated "It looks like EW0151. It looks like that or it EW6. Is it supposed to be 3 letters or 2 letter in front of that? It looks like EW0151 or it is  EW6151. She can't see if it was a zero or six". 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: Headache, Vaccination site rash
Clinical narrative: headache; small rash around the vaccination area.; This is a spontaneous report from Pfizer-sponsored program. A contactable consumer reported for self. A female patient of an unknown age received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on an unknown date in Mar2021 for Covid-19 immunization. Medical history and concomitant drug were not provided. Patient experienced a headache and small rash around the vaccination area.  Outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: diagnosed with COVID; diagnosed with COVID; This is a spontaneous report from a contactable consumer or other non hcp. A 62 year old female patient received the first dose of  bnt162b2 (BNT162B2, Solution for injection) via an unspecified route of administration on 27Mar2021as SINGLE DOSE and was scheduled for her second dose on 17Apr2021 for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On or about 17Apr2021, the patient underwent lab tests and procedures and diagnosed with covid positive which was considered serious as medically significant with an unknown outcome. Further patient asked if she can still take the second dose after more than 21 days. It was reported that patients husband also had COVID and was supposed to get vaccinated but had to cancel his appointment because of his diagnosis. The action taken in response to the event for bnt162b2 was not applicable. Follow up needed, further information was requested. information about lot/batch number needed.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain
Clinical narrative: pain all over his body/pain in my joints and all over my body; pain all over his body/pain in my joints and all over my body; This is a spontaneous report received from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 23Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  Historical vaccine included 1st dose of BNT162B2 for COVID-19 immunisation. About 4 days later (27Mar2021) of receiving 2nd dose of BNT162B2, patient got the pain in joints and all over body. Outcome of the events was unknown.  No follow-up attempts are possible. Information on lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Allergy to vaccine, Endometriosis, Inflammation, Oral herpes
Clinical narrative: allergic reactions; she developed herpes breakouts again but this time it appeared outside her mouth/around her mouth; she felt the endometriosis pain again.; She said her whole lower half is inflammed and bloated; She said her whole lower half is inflammed and bloated; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history included second degree endometriosis, the pain of her endometriosis started when she was 16 years old and it was treated until she was 23, she had 3 exploratory surgeries, and the endometrial area was cauterized years ago. The patient was previously vaccinated with the first dose of BNT162B2 at the age of 67-year-old for Covid-19 immunization and developed herpes breakout inside of her mouth and the upper part of her mouth turned into a blister. With the second dose of the vaccine, she developed herpes breakouts again but this time it appeared outside her mouth, it was around her mouth on an unspecified date. She felt the endometriosis pain again and her whole lower half was inflamed and bloated on an unspecified date. She was reading an article about mast cells which are part of the reaction in allergies involvement in the reaction of the Pfizer COVID-19 vaccine. She said the mast cells in a reproductive disorder increases the activation release of mediators. The patient was convinced that she was experiencing allergic reactions. She was surprised that she had these reactions since she said that she was in great shape and she was not overweight. She wanted to know if Pfizer has more information about how long the adverse events that she was experiencing would occur. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: runny nose on one side of her nostril.; sneezed; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect from a contactable female consumer (patient) reported for herself. A female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 13MAR2021 at single dose for COVID-19 Immunization. Medical history and concomitant medications were not reported. Patient got her first dose last March 13. She is scheduled to return today which is April 3 for her second dose. However, at 3 AM today upon waking up, she sneezed and started to have a runny nose on one side of her nostril. She is not sure if this is an allergy and she wanted to know if it was okay to get the shot. Provided PMI's number and hours of operation in case call gets disconnected since the caller has a medical inquiry. Cold Transferred to DSU and Created Manual AE Form. Customer and/or medical inquiry forwarded or referred to MI. Reported as non-serious. Patient stated she just had really, it was just a simple question. She had the first Pfizer shot on March 13th and she had no problem with it and she was scheduled today to get her second one and she woke up like in the middle of the night like she sneezed and like she just had this runny nose and she had no other symptoms. She felt fine and she just want to know if it was okay to get the shot. Outcome of event was unknown.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Hot flush, Presyncope, Vomiting
Clinical narrative: she began experiencing watery vomiting and diarrhea; she began experiencing watery vomiting and diarrhea; She also has chills; was having a hot flash; felt like she was going to faint/pass out; This is a spontaneous report from a contactable consumer. A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 03Apr2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 05Apr2021, the patient she was at work and felt like she was having a hot flash, then felt like she was going to faint/pass out. The following day (06Apr2021) she began experiencing watery vomiting and diarrhea. She also had chills.  The patient wanted to know if this is normal and was also asking if she experienced these side effects because she weighs 110 lbs. The outcome of the events was unknown.  No follow-up attempts are possible, information about the batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Off label use, Product use issue, SARS-CoV-2 test
Clinical narrative: I've already had Covid; I've already had Covid; The facility just called and said she needs another shot because the dose she received was mixed with sterile water due to running out of the "saline"; The facility just called and said she needs another shot because the dose she received was mixed with sterile water due to running out of the "saline"; This is a spontaneous report from a contactable consumer. A 51-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8732), dose 2 via an unspecified route of administration on 27Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient said I have already had covid on an unspecified date. The facility just called and said she needs another shot because the dose she received was mixed with sterile water due to running out of the saline (off label use and product use issue) on 27Mar2021. Caller states the vaccination site claims that someone from Pfizer told them that day that sterile water could be used as a diluent. When asked who at the site told her that she said she doesn't know. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown results. The outcome of the events off label use and product use issue recovered and others was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Caused me to test positive for COVID-19 10 days after receiving vaccine; Caused me to test positive for COVID-19 10 days after receiving vaccine; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7534), via an unspecified route of administration in left arm on 17Mar2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient caused to test positive for COVID-19 after receiving vaccine (drug ineffective).The patient underwent lab tests and procedures which included investigation: COVID-19 test positive on unspecified date .The outcome of the events was recovered with Sequel.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Deafness, Tinnitus, Vision blurred
Clinical narrative: Temporary hearing loss; ringing of the ears; Extreme cold sweats; Blurred vision; This is a spontaneous report from a non-contactable consumer for a 25-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in right arm on 07Apr2021 14:00 (Batch/Lot Number: EP7533) as SINGLE DOSE for covid-19 immunisation. Medical history included Covid-19 (Covid prior vaccination: Yes). Concomitant medications included sulfamethoxazole, trimethoprim.  The patient previously took a tetanus booster on left arm. The patient had a Covid prior vaccination and not Covid tested post vaccination. On 07Apr2021 at 14:00, the patient experienced temporary hearing loss, ringing of the ears, extreme cold sweats, and blurred vision. The patient did not receive treatment for the events. The outcome of events was recovered on 07Apr2021.  No follow up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Feeling a bit under the weather; This is a spontaneous report received from specialty pharmacy from a contactable consumer(patient). A 24-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via unknown route on Mar2021 (Batch/Lot number was not reported) at single for covid-19 immunisation; treprostinil sodium (REMODULIN, concentration of 5 mg/ml), iv drip from 30Jun2005 (Lot Number: 2101734; Expiration Date: 30Nov2021) to an unspecified date, at 0.150 ug/kg, continuing, for pulmonary arterial hypertension.  Medical history included ongoing pulmonary arterial hypertension. Concomitant medication(s) included warfarin sodium, ambrisentan and tadalafil, all taken for an unspecified indication, start and stop date were not reported.  It was reported that the patient felt a bit under the weather as he had his COVID shot recently. Action taken with IV Remodulin was not reported for the event of malaise. At the time of reporting, the outcome of malaise was unknown. The reporter did not provide causality for the event of malaise.  No follow up attempts are needed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: My arm did become sore; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received first dose and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration, administered in left arm on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient experienced really weird side effects after first dose of vaccination, patient arm become sore. The second shot was really bad, got a huge red blotch on her arm It was a big welt that look like a cloud, It became swollen and hot and 2 weeks later, patient arm is still really hurting but not red, hot or swollen". The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Experiencing pain in hands/wrists; Experiencing pain in hands/wrists; This is a spontaneous report received from a Pfizer-sponsored program, from a contactable other healthcare professional and consumer (patient). A thirty-eight-year-old female patient received BNT162b2 (BNT162B2), dose 1 via an unspecified route of administration on 31, Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 Immunizations. Medical history included depression, rheumatoid arthritis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced pain in hands/wrists and trouble opening bottles due to the missed doses of tofacitinib citrate (XELJANZ) on an unspecified date in 2021 with outcome of unknown.  Follow-up (19Apr2021): New information included report type updated as spontaneous. This follow-up is being submitted to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Inappropriate schedule of product administration, Off label use, SARS-CoV-2 test
Clinical narrative: Diagnosed with Bell's Palsy on right side of my face; administration date 02Mar2021/ number 2; administration date 09Mar2021/dose number 1; administration date 02Mar2021/ number 2; administration date 09Mar2021/dose number 1; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route of administration at 32-years, at single dose in right arm on 02Mar2021 (as source reported; pending clarification) at 13:00 (Lot number: unknown) for COVID-19 immunisation. Medical history included high blood pressure and high cholesterol. Concomitant medications included atenolol, amlodipine and atorvastatin, all taken for an unspecified indication, start and stop date were not reported. The previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) also via an unknown route of administration at 32-years, at single dose in right arm on 09Mar2021 at 08:30 for COVID-19 immunisation. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with Bell's Palsy on right side of his face on 06Apr2021 06:00. The adverse event resulted in "Doctor or other healthcare professional office/clinic visit". And the patient received treatment with prednisone and valacyclovir for it. The patient was not diagnosed with COVID-19 prior to vaccination. He had Covid test (IDNOW COVID-19 rapid diagnostic test (nucleic acid amplification test NAAT)) post vaccination with type of Nasal Swab on 30Mar2021 with a result of negative. Event outcome was recovering.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: sore throat; This is a spontaneous report from a Pfizer sponsored COVAX Support reported by a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine), via an unspecified route of administration on an unspecified date as single dose for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was due for her 2nd dose of Covid vaccine next Saturday but she would like to reschedule as she has a sore throat. Event outcome was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pneumonia, SARS-CoV-2 test
Clinical narrative: and 09Mar diagnosed with pneumonia, caller was released from hospital on 24Mar; COVID 04Mar, and 09Mar diagnosed with pneumonia, caller was released from hospital on 24Mar; This is a spontaneous report from a contactable consumer (patient). A female patient of unknown age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection),via an unspecified route of administration on 27Feb2021 as single dose for COVID-19 immunisation. The patient medical history was none. The concomitant medications were not reported. Patient received first dose 27Feb2021. Diagnosed with COVID 04Mar2021, and 09Mar2021 diagnosed with pneumonia, she was released from hospital on 24Mar2021. Caller would like to know if she can get the second dose of vaccine. The patient outcome for the events was unknown.   Information on the lot/batch number has been requested.   Follow-up attempts were completed. No further information was expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic shock, Fear of death
Clinical narrative: fear of death/doom; I went into a full Anaphylaxis shock; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EW0150) via an unspecified route of administration, administered in Arm Left, at the age of 32-year-old,  on 06Apr2021 09:45, as SINGLE DOSE for covid-19 immunisation.  Medical history included allergy to shrimp. The patient was not diagnosed with COVID nor was he tested post vaccine. The patient's concomitant medications were not reported.  On 06Apr2021 at 10:00 am, 15 mins after the vaccine, a large hive appeared on his forehead and then 1.5 hours later the patient went into a full Anaphylaxis shock with difficulty breathing, throat closing up, fear of death/doom, tingling sensation in whole body, heart pounding rapidly, chest pain, dizziness. The patient went to the emergency room/ urgent care and was hospitalized for 1 day. Therapeutic measures taken in response to the events included administration of Steroids, antihistamines, and pain killers. Outcome was recovering at the time of the report.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Vaccination site pain
Clinical narrative: headache; aches; injection site soreness; This is a spontaneous report from Pfizer-sponsored program from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included knee pain and nausea. Concomitant medication(s) included paracetamol (TYLENOL) taken for knee pain. Patient was told to take Tylenol. She had issue with her knee. She wanted to know if she can take any other pain reliever. She has had knee issue prior to getting vaccinated. She had been having nausea as well. She had experienced headache, aches, and injection site soreness on unspecified date. But it has gone away. The event outcome for events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vomiting
Clinical narrative: Fatigue; vomiting; This is a spontaneous report from a contactable consumer. A 26-year-old female patient (non pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 06Apr2021 at the age of 26-year-old (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 experienced fatigue and vomiting on 06Apr2021 21:00 with outcome of recovered on an unspecified date in Apr2021. No treatment was received for the adverse events. No COVID 19 diagnosed prior vaccination, since the vaccination the patient hadn't been tested for COVID-19.  No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Bell's palsy, Feeling abnormal, Hypoaesthesia, Paraesthesia
Clinical narrative: Bell's Palsy; something felt weird; asthma; facial numbness and tingling; facial numbness and tingling; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection),  dose 1 via an unspecified route of administration administered in arm left on 05Apr2021 (Batch/Lot Number: ER8727) at age of 51 years old as single dose for covid-19 immunisation. There was no medical history.  There was no history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. No events following prior vaccinations. There were no concomitant medications.  The patient had her 1st dose of Pfizer Covid-19 vaccine on Monday morning (05Apr2021).  The patient experienced facial numbness and tingling on 05Apr2021. After the injection she sat and waited for 15 minutes. When she got in the car, she felt her face tingling.  It had been a couple days of having the sensation in her face.  She called her physician and it was labeled as Bell's Palsy.  Her physician suggested she phone and report her experience. She had her appointment at 11:30. She was back in her car around 13:00. She noticed as she was driving, that something felt weird.  She didn't know if it was numbness or tingling.  She added it was not painful and she was not distorted.  She thought it's numb. Her physician advised she take Motrin.  Her physician shared an article about a trial that some people may experience this after, it included 4-5 people. Her symptoms shifted.  First in her cheeks, then over the course of yesterday and today, she feels it's on the side of her face.  The forehead had gone away, but it's on the right side of her face.  She added the symptoms were improving and clarified they were persisting. She had asthma and wanted to minimize the severity of Covid if she would ever get it. She had loved ones around and added that you never know.  She wanted to protect herself. She wanted to get out and see her family and friends. Some of them have already been fully vaccinated. She was concerned when it started. It wasn't affecting her breathing, but she called her physician and asked if she needed to come in.  Her physician suggested to just monitor it. The events did not require visit to emergency room or physician office. The outcome of events facial numbness and tingling was not recovered. The outcome of other events was unknown.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: I felt a little woosy; This is a spontaneous report from a contactable other health care professional (patient).  A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 1st via an unspecified route of administration, administered in Arm Right on 05Apr2021 13:00 as single dose for covid-19 immunisation. Medical history included Severe back problems. Patient had allergies to Chocolate. Concomitant medication was not reported. On 05Apr2021 01:15, patient felt a little woosy. She was not pregnant at the time of vaccination, did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received other medications within 2 weeks of vaccination. She was not received treatment for the adverse event. Patient was not diagnosed with COVID-19 Prior to vaccination, since the vaccination, not been tested for COVID-19. The outcome of the event was recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis
Clinical narrative: he had been sweating profusely for almost 3 weeks; This is a spontaneous report from a contactable consumer (patient). This unknown age male patient received 1st dose of COVID-19 Vaccine BNT162B2 (Batch/lot number: Not Provided) at single dose for COVID-19 immunization. Medical history and concomitant drug were not reported. Reported he had his first COVID-19 Vaccine and had a weird reaction. He said he had been sweating profusely for almost 3 weeks. He said everyone kept telling him that his sweating doesn't make sense, and his sweating should only have lasted a few days. Outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Inappropriate schedule of product administration, Off label use
Clinical narrative: Painful lump in left armpit; administration date26Feb2021, administration date 15Mar2021; administration date 26Feb2021, administration date 15Mar2021; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient (not pregnant) received bnt162b2 (COVID-19 vaccine), dose 2 via an unspecified route of administration, administered in Arm Left on 15Mar2021 09:45 AM (Batch/Lot number was not reported) at single dose for covid-19 immunisation. The patient' medical history was not reported, no allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications within 2 weeks of vaccination included: Metformin, alprazolam (XANAX) and multivitamin. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of bnt162b2 administered in Arm Left on 26Feb2021 09:00 AM for covid-19 immunization and experienced black nasal discharge. The patient experienced painful lump in left armpit since vaccines. It's been almost a month. Adverse event started from 15Mar2021 09:45 AM. No treatment was received for the event. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was not recovered. The report was non-serious.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Movement disorder, Pain, Vomiting
Clinical narrative: This is spontaneous report received from contactable consumer. A female patient of an unspecified age received the second dose of BNT162B2 (COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced chills, throwing up, can't move, everything hurts on 05Apr2021. The reporter was calling for her sister and she has got every symptom yesterday (05Apr2021) after getting the second shot. The patient had chills, throwing up, can't move, everything hurts, and just every single thing from the list. The reporter was asking is this normal having all these at the same time. The reporter was thinking if her sister had the vaccine and has such a reaction can she get an antibody infusion. The patient had a list of symptoms and checked them off and she has all of them. The reporter is wondering if her sister is a candidate if she got the vaccine and not like it's a live vaccine, she knew that, but would antibody therapy be good for her and she doesn't know what to do she felt helpless. Caller stated she knew these are side effects. The outcome of the events was unknown. No Follow-up attempts are needed. No further information is expected. Information about lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: A spike in her BP; This is a spontaneous report from a contactable pharmacist. A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) intramuscularly in the left arm on 11Mar2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension from an unspecified date and unspecified if ongoing (not taking meds for this prior to this event) and strawberries - anaphylaxis from an unspecified date and unspecified if ongoing. It was unknown whether the patient was diagnosed with COVID-19 prior to vaccination. It was unknown if the patient was pregnant. Concomitant medications ("other medications in two weeks") included acetaminophen taken for an unspecified indication from an unspecified date and unspecified if ongoing, as needed. It was unknown whether the patient received any other vaccine within four weeks of the COVID-19 vaccine. The patient experienced a spike in her BP (blood pressure) on an unspecified date ("with her first dose"). The clinical outcome of the event a spike in her BP was unknown. Since the vaccine, it was unknown whether the patient was tested for COVID-19.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of "a spike in her BP" cannot be excluded. The event was confounded by underlying hypertension. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm at injection site; This is a spontaneous report from two contactable consumer (one of them is parent). A 23-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration at age of 23-year-old at arm on 03Apr2021 12:30 PM at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient hadn't allergies to medications, food, or other products. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered in Pharmacy or Drug Store. The patient experienced sore arm at injection site in Apr2021. No treatment received for event. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: scratchy throat; This is a Spontaneous report from Pfizer program. A contactable female consumer (patient) of unspecified age reported that she received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 13Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The medical history and concomitant medications were not reported.  The patient experienced scratchy throat in 2021 with outcome of unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Swelling
Clinical narrative: can not walk at all; Swelling; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot number unknown), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced cannot walk at all and swelling. The outcome of the events were unknown.  No Follow-up attempts are needed. No further information is expected
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This week i should take my 2nd dose but i was scheduled for surgery on 09Apr2021, so they let me do covid test then the results is positive; This week i should take my 2nd dose but i was scheduled for surgery on 09Apr2021, so they let me do covid test then the results is positive; This is a spontaneous report from a contactable Other-health care professional. A 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 06Mar2021 13:15 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient not administered other vaccine in four weeks. This week patient should take her 2nd dose but she was scheduled for surgery on 09Apr2021, so patient underwent lab test on 07Apr2021 14:00, covid test type post vaccination=Nasal Swab, covid test name post vaccination Rapid test, covid test date 07Apr2021, covid test result=Positive. Patient received treatment with Tylenol. Patient not had Covid prior vaccination; Patient was tested Covid post vaccination. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the known safety profile and a strong temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported COVID-19.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood glucose decreased, Blood test, Chest X-ray, Dyspnoea
Clinical narrative: she feels weak; Blood Sugar Drops at Lunch; feeling bad; hear wheezing in the stethoscope; Shortness of breath; kind of fatigued; This is a spontaneous report received from a contactable consumer reporting for his wife (patient). This 64 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EP7534), single dose, dose 1  via an unknown route of administration in the left arm on 17Mar2021 at 08:30 (at the age of 64 years-old) for COVID-19 vaccination. Medical history included aortic aneurysm  from 2012 to 2012, thyroid problems and headache. There was no family history. The patient did not receive  any other vaccine within 4 weeks prior to the vaccine. There were no events following prior vaccinations. Concomitant medications were not reported. In Mar2021, a week after vaccine administration, the patient was kind of fatigued. She went to the doctor in Mar2021 because she was feeling bad and they said they could hear wheezing in the stethoscope when they listened to her lungs. She was sent her for x-ray and they are waiting on the results. He said that this can also be symptoms of something going on with her thyroid and he has been trying to get her to go to the doctor. He stated she goes up and down the stairs at work and hasn't had problems but has noticed she feels weak and he has noticed she is getting more fatigued everyday. On 24Mar2021, the patient had no energy and her blood sugar has been dropping sometimes at lunch and has never had problems with it before. it is not all the time but when she comes home for lunch after she eats, it drops low. It happens sometimes at lunch, never at breakfast nor supper. In Mar2021, the patient experienced shortness of breath for the last couple of weeks, especially with the stairs. The patient went to the physician's office on 07Apr2021. Laboratory tests included blood work  due to the patient's thyroid problems, blood sugar decreased and chest x-ray all on 07Apr2021. The clinical outcome of weak, shortness of breath, feeling bad, wheezing, fatigued and blood sugar dropped was unknown.    No follow-up attempts are needed. No further information is expected.