chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nauseous; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced nauseous on an unspecified 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: Asthenia, Feeling abnormal, Pain, Pain in extremity
Clinical narrative: We both had a sore arm around 3:30 in the afternoon; excruciating pain going through my body/pain was off the scale; I felt like I was dying. I felt my life force was leaving me and all my necessary internal organs were shutting down; I felt so weak I couldn't even talk for 6 days; This is a spontaneous report from a contactable consumer (patient) .This case refers to events occurred after second dose of BNT162B2.  A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported) on 08Mar2021 at single dose for covid-19 immunisation. The patient medical history included surgeries . Concomitant medications were not reported. Previously on 15Feb2021 patient received the first dose of the vaccine and after receiving the vaccine, she was extremely fatigue ,had a little pain in her arm and she couldn't get from one room to another; it only lasted a day.Patient took the second dose on 08Mar2021  and had a sore arm around 3:30 in the afternoon. However, 11 -12 hours later (in Mar2021) she was awaked by excruciating pain going through her body. It felt like all the surgeries, concussion and multiple injuries she had in the past manifestoing all at once.Her pain was off the scale. None of the opioids would have helped, she took morphine which didn't help. She felt like she was dying, she felt her life force was leaving her and all her necessary internal organs were shutting down. These symptoms lasted 6 days. She stated she wouldn't have survived if her husband wasn't with her. She felt so weak she couldn't even talk for 6 days in 2021. Patient was okay at reporting time. She didn't do well with chemical that why she took natural treatments. Patient was diagnosed with Hashimoto disease, dysautonomia and hyper mobility on an unknown date. The outcome of the events Hashimoto disease, dysautonomia and hyper mobility was unknown; outcome of the other events was recovered on an unknown date in 2021.Information about lot/batch has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021405494 same patient/drug, different dose/AE
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: hearing loss; Tinnitus; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration (at the age of 36-years-old), administered in Arm Left on 30Mar2021 (Lot Number: ER8730) as single dose for COVID-19 immunization. The patient's medical history was not reported. The patient had no known allergies. There were no concomitant medications. The patient previously received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration (at the age of 36-years-old), administered in Arm Left on 02Mar2021 04:00 PM (lot number: EN6205) as single dose for COVID-19 immunization. The patient experienced hearing loss and tinnitus on 30Mar2021. No treatment received for adverse events. The outcome of the events was not recovered. The event hearing loss was considered as serious (medically significant).  Facility type vaccine was Pharmacy or Drug Store. No other vaccine in four weeks. No other medications in two weeks. Not diagnosed with COVID prior vaccination. Not COVID tested post vaccination.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site swelling
Clinical narrative: took the first dose of vaccine and arm is swelling; fever; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on Apr2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient medical history and patient's concomitant medications were not reported. Patient stated took the first dose of vaccine and arm was swelling and patient was feeling not bad but next day afternoon like more than 24 hours later patient got the fever. The event outcome for events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: patient received his first dose of the vaccine on 22Mar2021 and after that became infected, tested positive for Covid 19; patient received his first dose of the vaccine on 22Mar2021 and after that became infected, tested positive for Covid 19; This is a spontaneous report from a contactable pharmacist. A 46-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6204, expiry date Jun2021), via an unspecified route of administration on 22Mar2021 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The pharmacist stated that the patient received his first dose of the vaccine on 22Mar2021 and after that became infected, tested positive for Covid 19 on an unspecified date in 2021. The pharmacist reported that the patient has fully recovered from having Covid 19. The outcome of the events was recovered on an unspecified date in 2021. The patient asked the pharmacist for the soonest time that he can get his second dose if it was 10 days or longer.; Sender's Comments: As there is limited information in the case provided, the causal association between the event  COVID-19 and the suspect vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Crohn's disease, Gastrointestinal disorder, SARS-CoV-2 test
Clinical narrative: My Crohns seems to be worse, with more digestive issues since the vaccination.; My Crohns seems to be worse, with more digestive issues since the vaccination.; This is a spontaneous report from a contactable consumer. A 49-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 15Jan2021 17:45 (Batch/Lot Number: ek9231), and dose 2 via an unspecified route of administration, administered in Arm Left on 05Feb2021 (Batch/Lot Number: en5318) as a single dose for covid-19 immunization (given at the age of 49 years). The patient's medical history included crohns disease, damaged kidneys, and allergies to almonds, watermelon, pineapple, avocado, peanuts. Concomitant medications included ustekinumab (STELARA); ciprofloxacin; famotidine (PEPCID [FAMOTIDINE]); omeprazole (OMEPRAZOLE); and montelukast (MONTELUKAST). The patient previously took morphine and experienced drug allergies. On 15Feb2021, the patient experienced his crohns seems to be worse, with more digestive issues since the vaccination. Patient was not treated for the events. The patient underwent lab tests and procedures which included negative covid-19 test on (RNA, Qualitative RT-PCR TF) 09Feb2021, 11Mar2021 and on (RNA, Qualitative RT-PCR TF) 06Apr2021. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm that received the vaccination was mildly sore for several hours the day after the vaccination; This is a spontaneous report from a contactable consumer. A adult male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date and dose 2 administered in right arm as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Allergies to medications, food, or other products was unknown. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown if Since the vaccination, the patient been tested for COVID-19 or not. His arm that received the vaccination was mildly sore for several hours the day after the vaccination. The event assessed as non-serious with outcome recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Eye irritation, Inappropriate schedule of product administration, Lacrimation increased, Off label use
Clinical narrative: The pollen in the air is very bad; my eyes started to water really bad and they burn; The pollen in the air is very bad; my eyes started to water really bad and they burn; first dose on 28Mar2021, second dose on 11Apr2021; first dose on 28Mar2021, second dose on 11Apr2021; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Unspecified number) via an unspecified route of administration on 11Apr2021 (Lot Number: Unknown) as single dose for covid-19 immunisation.  The patient medical history was not reported. Concomitant medication included paracetamol (TYLENOL). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Mar2021 for covid-19 immunisation. The patient reported that he/she had first COVID shot Pfizer on 28Mar2021. Today (on 11Apr2021) he/she had second one that was 22 days later not 21 days, there was no problem he/she didn't sick or anything but the pollen in the air was very, very bad when he/she came outside his/her eyes started to water really, really bad and they burn. And the patient reported "Because I read everything I could on the paper but I would like to take a Benadryl tablet for my eye. But I would not take anything that might make me sick or that I should not take. So I wanted to know, is it okay to take either a Benadryl tablet or Tylenol?". Events outcome was unknown.    Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Purpura, Pyrexia
Clinical narrative: bloody spot on arm and inner lip; fever; arm pain; This is a spontaneous report from a contactable consumer (patient reported for herself).   A 28-years-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Mar2021 (Batch/Lot Number: EN6206) as SINGLE DOSE for covid-19 immunisation.  Medical history included penicillin allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.  The patient previously took olive (olea europaea) and experienced drug hypersensitivity.   The patient experienced bloody spot on arm and inner lip (purpura) (non-serious) on an unspecified date with outcome of unknown , bloody spot on arm and inner lip(non-serious) on an unspecified date with outcome of unknown , fever (pyrexia) (non-serious) on an unspecified date with outcome of unknown , arm pain (pain in extremity) (non-serious) on an unspecified date with outcome of unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Hypersensitivity, Sunburn
Clinical narrative: Feels like a sunburn on arms face and neck; her arm is not red or anything and that everything is internal. It started in her arms and is just burning.; possibly be a mild allergic reaction; This is a spontaneous report from a contactable consumer. A 66-year-old female patient received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: EP-7533) via an unspecified route of administration on 12Apr2021 at a single dose for covid-19 immunisation. Medical history included prebiabetes and other conditions: She states her A1C is great. She was diagnosed more than 10 years ago. She does have a family history of diabetes. The prediabetes is controlled and allergies (she is highly allergic to a lot of things). She states she was diagnosed as a child so well over thirty years ago. Like hay fever and that kind of thing. The patient's concomitant medications were not reported. She states that she does take an inhaler. No prior vaccination within 4 weeks. When she was a child the small pox vaccine never would take so they figured she was immune to it. On 12Apr2021, within 30 minutes to an hour of receiving the vaccine, the patient feels like a sunburn on arms face and neck and her arm is not red or anything and that everything is internal. it started in her arms and is just burning. It was like a hair dryer was blowing. She states that when she checked her temperature that it normal. She wondered if that was a side effect. She states that her arm is not red or anything and that everything is internal. It started in her arms and is just burning. It started in the arm of the inject which was her left arm then went to her right arm. On 13Apr2021 (on the day of reporting), went to neck and face. She states that it has not spread anywhere else. She states that she thought it was from the shot and her immune system is fighting it. She states that her physician did urge her to get the vaccine. She states that her symptoms are just there a little, she was uncomfortable but it has diminished since she has taken Acetaminophen but did not take them away. She had flushing and she checked her temperature and didn't have a temperature, it was like she has been out in the sun and like an uncomfortable burning internally. States it is not on the skin. with the flushing she doesn't have redness or a fever. On15Apr2021 (on the day of reporting of followup), spread into her neck and collar bone area and her arms. She did take Acetaminophen and she doesn't feel that is as intense. She states that her symptoms are just there a little, she is uncomfortable but it has diminished since she has taken Acetaminophen. Caller states she read online this could possibly be a mild allergic reaction and states she is highly allergic to a lot of things. The outcome of events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Dysmenorrhoea, Feeling abnormal, Headache, Heavy menstrual bleeding
Clinical narrative: extremely strong menstrual cramping and bleeding; extremely strong menstrual cramping and bleeding; Throbbing pains in the side of head; Extremely cloudy in the head; Attention span is limited; Migraines longer than 4 days; This is a spontaneous report from a contactable consumer (patient). A 21-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via an unspecified route of administration, administered in left arm on 06Apr2021 at 08:15 AM, at 21 years of age, (Batch/Lot Number: EW0150) as single dose for COVID-19 immunization. The patient had no relevant medical history. She was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient was not pregnant. Concomitant medication included etonogestrel (NEXPLANON) 68 mg taken for an unspecified indication since an unknown date. On 07Apr2021 at 14:30 the patient experienced extremely strong menstrual cramping and bleeding, throbbing pains in the side of head, extremely cloudy in the head, attention span was limited and migraines longer than 4 days. The patient didn't receive any treatment. At the time of the report the reported events had not resolved yet.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: extremely strong menstrual cramping and bleeding; extremely strong menstrual cramping and bleeding; Throbbing pains in the side of head; Extremely cloudy in the head; Attention span is limited; Migraines longer than 4 days; This is a spontaneous report from a contactable consumer (patient). A 21-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via an unspecified route of administration, administered in left arm on 06Apr2021 at 08:15 AM, at 21 years of age, (Batch/Lot Number: EW0150) as single dose for COVID-19 immunization. The patient had no relevant medical history. She was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient was not pregnant. Concomitant medication included etonogestrel (NEXPLANON) 68 mg taken for an unspecified indication since an unknown date. On 07Apr2021 at 14:30 the patient experienced extremely strong menstrual cramping and bleeding, throbbing pains in the side of head, extremely cloudy in the head, attention span was limited and migraines longer than 4 days. The patient didn't receive any treatment. At the time of the report the reported events had not resolved yet.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: still a little sick from Pfizer shot; This is a spontaneous report from a contactable consumer. An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history included COVID-19. The patient's concomitant medications were not reported. The patient experienced still a little sick from Pfizer shot on an unspecified date with outcome of unknown. No treatment received for the event.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Dysphagia, Malaise, Nausea, Nephrolithiasis, Obstructive airways disorder
Clinical narrative: felt like have kidney stones; It was like the food would not go down/the food wouldn't pass; almost turned blue; Like airway was closed up; wanted to throw up; like deathly ill; This is a spontaneous report from a contactable consumer (patient's friend). This consumer reported similar events for two patients. This is the second of two reports. A 46 years old patient of unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA 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 immunization. Medical history and concomitant medications were not reported.  The reporter experienced "feels like I have kidney stones", "like the food wouldn't go down", "almost turned blue like the food wouldn't pass", "It was like my airway was closed up", "Like I wanted to throw up" and "like deathly ill". It was reported that the patient experienced the same weird side effects as the reporter had experienced after the covid19 vaccine. The outcome of the events was not reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021417459 same reporter, drug and events, different patient.
Sex: U
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: felt like have kidney stones; It was like the food would not go down/the food wouldn't pass; almost turned blue; Like airway was closed up; wanted to throw up; like deathly ill; This is a spontaneous report from a contactable consumer (patient's friend). This consumer reported similar events for two patients. This is the second of two reports. A 46 years old patient of unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA 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 immunization. Medical history and concomitant medications were not reported.  The reporter experienced "feels like I have kidney stones", "like the food wouldn't go down", "almost turned blue like the food wouldn't pass", "It was like my airway was closed up", "Like I wanted to throw up" and "like deathly ill". It was reported that the patient experienced the same weird side effects as the reporter had experienced after the covid19 vaccine. The outcome of the events was not reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021417459 same reporter, drug and events, different patient.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Choking sensation, Dry throat, Herpes virus infection, Hypoaesthesia, Pain
Clinical narrative: numbness in her extremities; tingling in her extremities; break out like herpes near her buttocks/break out on top of her eye; has a dry throat no matter how much she drinks; stated that she has a choking feeling like something is stuck in her throat; stated that she has a choking feeling like something is stuck in her throat; stated that she has aches/pains in her body; has a crawling itch in her body and legs; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 03Apr2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient stated that she got vaccinated on 03Apr2021 and had a mild side effect. Stated that after 5-7 days that she had numbness and tingling in her extremities and a break out like herpes near her buttocks. Stated that 15Apr2021 morning she had a breakout on top of her eye. Was scheduled to go to urgent care 16Apr2021 at 8am. Stated that the nurse told her to take Benadryl. Stated that she had a dry throat no matter how much she drank. Stated that she had a choking feeling like something was stuck in her throat. Stated that she did not have a fever. Stated that she had aches/pain in her body. Stated there was crawling itch in her body and legs. Stated that she got worried about it. Is for the Pfizer Covid vaccine. Stated that she called the CDC earlier and left a message. Stated that she would ask her doctor when it all went away if she should get the second dose. Stated that her second dose was on 24Apr2021. Outcome of the events was unknown.   Information on the Lot/Batch number has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus, Sensation of foreign body
Clinical narrative: numbness in her extremities; tingling in her extremities; break out like herpes near her buttocks/break out on top of her eye; has a dry throat no matter how much she drinks; stated that she has a choking feeling like something is stuck in her throat; stated that she has a choking feeling like something is stuck in her throat; stated that she has aches/pains in her body; has a crawling itch in her body and legs; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 03Apr2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient stated that she got vaccinated on 03Apr2021 and had a mild side effect. Stated that after 5-7 days that she had numbness and tingling in her extremities and a break out like herpes near her buttocks. Stated that 15Apr2021 morning she had a breakout on top of her eye. Was scheduled to go to urgent care 16Apr2021 at 8am. Stated that the nurse told her to take Benadryl. Stated that she had a dry throat no matter how much she drank. Stated that she had a choking feeling like something was stuck in her throat. Stated that she did not have a fever. Stated that she had aches/pain in her body. Stated there was crawling itch in her body and legs. Stated that she got worried about it. Is for the Pfizer Covid vaccine. Stated that she called the CDC earlier and left a message. Stated that she would ask her doctor when it all went away if she should get the second dose. Stated that her second dose was on 24Apr2021. Outcome of the events was unknown.   Information on the Lot/Batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Fatigue, Pyrexia
Clinical narrative: lower back is hurting; Slight fever, going up and down, like the lowest was100 and the highest it went was 101.4, it was 101.2 now; tired; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0150 and expiry: not reported), via an unspecified route of administration, administered in arm left/left shoulder on 12Apr2021 11:00 as single dose for COVID-19 immunization/so that she won't get COVID (at the age of 53-year-old). Medical history included ongoing being diabetic for about 10 years (Investigation Assessment: Yes). Concomitant medications: She was taking a lot of medications but did not think any of them were important to report here. History of all previous immunization with the Pfizer vaccine considered as suspect was none. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks) and the patient declined being sick at the time of vaccination. On 12Apr2021 (Monday), the patient had been having a slight fever ever since Monday night to now. She said it was going up and down, like the lowest was 100 and the highest it went was 101.4, it was 101.2 now. On 12Apr2021, she was still tired, her lower back was hurting, and asked how long this fever was going to last. On 15Apr2021, body temperature test showed 101.2 Fahrenheit and 101.4 Fahrenheit. She had taken Tylenol (Lot number, NDC number, expiration date not provided) as therapeutic measure but that was not working, and she couldn't take anything that was ibuprofen because of a medication she was on. After being referred to her physician, the patient said she was going to go to the emergency department. Seriousness of events was not specified. The outcome for all the events was not recovered. No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure increased, Blood pressure measurement, Chills, Fatigue
Clinical narrative: COVID vaccine Chills & difficulty getting out of the bed " I cant get out of bed; COVID vaccine Chills & difficulty getting out of the bed " I cant get out of bed; elevated blood pressure; feels being tired lately; This is a spontaneous report received from a contactable consumer, A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiry date were not provided), via an unspecified route of administration, on 17Mar2021, as single dose for covid-19 immunization. The patient's cosuspect medication included LENVIMA 20 mg, orally for Endometrial Cancer on 13Mar2021. Patient medical history included hypertension and receiving treatment which inluced diltiazem /triamterene/Olmesartan for pre-existing hypertension, MD is unaware. MD follow-up on 29Mar2021. The next COVID vaccine is on 17Apr2021. On 17Mar2021 patient had chills and difficulty getting out in the bed (she cannot get out of bed) symptoms of the COVID 19 lasted for two days (resolved) and increased the blood pressure 143/101 (elevated), when the day she had the vaccine. No missed doses and no hospitalization noted. She feels being tired lately, started after taking the therapy on Mar2021. The patient underwent lab test and procedures which included blood pressure (143/101) on 17Mar2021. Outcome of the events chills and difficulty getting out in the bed resolved on 20Mar2021 and outcome of the events feels being tired lately and elevated blood pressure was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Malaise, Pain, Rash
Clinical narrative: I felt very tired; Felt sore and achy like I had Flu; Felt sore and achy like I had Flu; Broke out with the rash; rash in my chest and my tummy following day was worst; it came up to my neck, travelling to my arms and my back; I didn't feel good; felling so bad; This is a spontaneous report from a contactable consumer (patient). A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on an unspecified date (Lot Number: EN6208) as SINGLE DOSE for covid-19 immunisation; benzylpenicillin sodium (PENICILLINE), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication  .  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient had gotten the first Pfizer injection last week on Wednesday and might of like an hour later patient felt very tired that was okay. Then next day, the patient just felt sore and achy just like had the Flu and then by the evening patient broke out with the rash. The rash was little bit in chest, it was a little bit in tummy and then the following day was worst. It was travelling, it came up to neck, all arms and my back. It was just a rash but didn't feel good, looking at that of course not feeling good, didn't know how. The patient finally decided because it happened, I pick up some Benadryl and took that for 2 days and half and finally they are going away.  The action taken in response to the events for benzylpenicillin sodium was unknown.  The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Low grade fever; chills; body aches; This is a spontaneous report from a contactable consumer (patient's husband). A 55-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EP6955, Expiration date: Unknown), via an unspecified route of administration in the left arm on 12Apr2021 10:15 as SINGLE DOSE for covid-19 immunisation. The patient's medical history included none. The patient had no allergies to medications, food, or other products. Concomitant medication included valaciclovir hydro-chloride (VALTREX) and doxycycline monohydrate (DOXYCYCLIN "GENERICON" 100). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EP6955, Expiration date: Unknown), via an unspecified route of administration in the left arm on 22Mar2021 as SINGLE DOSE for covid-19 immunisation. The patient experienced low grade fever, chills and body aches on 12Apr2021 10:30. The patient was not diagnosed to COVID-19 prior to vaccination and since vaccination. The patient did not receive treatment. The outcome of events were recovered.  No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Nasal oedema
Clinical narrative: discomfort under the armpit; Swelling in nose; This is a spontaneous report from a contactable consumer (patient). The 68-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as SINGLE DOSE for covid-19 immunization, at the age of 68 years old. The patient medical history and concomitant medications were not reported. The patient experienced discomfort under the armpit, swelling in nose on an unspecified date. Reported as: Consumer stated, "I have the vaccine, the COVID, the Pfizer on Thursday about 5 or 5:30 and I experiencing the discomfort under the armpit and I got swelling in nose." The patient took Aspirin as treatment. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: not feeling well; Fever; This is a spontaneous report received from a contactable consumer reporting for herself. A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Apr2021 (lot number: ET7533) at single dose for COVID-19 immunization. Medical history included heart problems. Concomitant medications were not reported. The patient stated, "I got the Pfizer shot in Friday and I still am not feeling well (Apr2021). I have a fever (Apr2021) right now that I caught. Is that a side effect after 3 days?" Treatment received for the events included Ibuprofen. The outcome of the events were unknown.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Drug ineffective, Fatigue, Myalgia
Clinical narrative: also like Covid over again; also like Covid over again; Tired; Weak; Lots of muscle pain aching; Aching; had a reaction after taking when took deep breath taking my chest; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of bnt162b2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had an adverse reaction and people told patient the first shot usually don't. Patient was like very tired, weak, lots of muscle pain, aching and patient also like Covid over again you know and it last for three or four days. Patient's question was should patient surely get a second shot or should leave. Because patient heard people have been getting pretty sick after the second shot and patient didn't know. Patient had a reaction after taking when took deep breath taking chest. Patient mean it is now since subsided. It has been a week now or 7 days or 6 days, but patient had 4 days back the reactions from. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Suspected COVID-19
Clinical narrative: also like Covid over again; also like Covid over again; Tired; Weak; Lots of muscle pain aching; Aching; had a reaction after taking when took deep breath taking my chest; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of bnt162b2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had an adverse reaction and people told patient the first shot usually don't. Patient was like very tired, weak, lots of muscle pain, aching and patient also like Covid over again you know and it last for three or four days. Patient's question was should patient surely get a second shot or should leave. Because patient heard people have been getting pretty sick after the second shot and patient didn't know. Patient had a reaction after taking when took deep breath taking chest. Patient mean it is now since subsided. It has been a week now or 7 days or 6 days, but patient had 4 days back the reactions from. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Light headedness and dizzy; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 11Apr2021 (Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had his/her vaccine today (on 11Apr2021), it made him/her dizzy and light headed. And the patient asked, "Can I still take my potassium medicine that I take daily?  My potassium pill, that I take daily for my cholesterol and I took my blood pressure pill before I had vaccine. I want to confirm do we still take it or should you wait till the next day". Events outcome was unknown.  Information on the lot/batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Rash, Vaccination site rash
Clinical narrative: Arm hurt and itched a lot; Arm hurt and itched a lot; Rash all over her belly; A bit of rash around the injection site; This is a spontaneous report from a contactable retired emergency medical technician (HCP) who is also the patient. A 63-year-old female patient received BNT162b2 (BNT162B2), dose 2, via an unspecified route of administration, administered in arm, on an unspecified date, at the age of 63years old, as single dose, for COVID-19 immunisation. Medical history included ongoing early Alzheimer's with cognitive issues, stroke in 2020 with half paralysis of the throat causing a drop in her voice, ongoing chronic obstructive pulmonary disease with problems breathing, and ongoing incontinence. Concomitant drugs included 32 unspecified drugs. Past drug history included 1st dose of BNT162b2 on 14Jan2021 (lot number: EK2176), at the age of 63 years old, as single dose, administered in arm. The first administration of BNT162b2, her arm hurt and itched. After the second dose of BNT162b2, the patient's arm hurt and itched a lot, as after the 1st dose of BNT162b2. About 2 weeks after vaccination the patient developed a rash all over her belly and a bit of rash around the injection site. The event outcome was not specified.   Information about the Lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Diarrhoea, Dyspepsia, Flatulence
Clinical narrative: Indigestion; gas; Loose stools; had my heart checked out after my first vaccine because it comes along with chest pain as well and that came back clear; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient stated that after first shot developed digestion issue, indigestion, gas and loose stools and it took about 3 weeks to go away. Patient had heart checked out after first vaccine because it comes along with chest pain as well. Outcome of events was recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Haematochezia
Clinical narrative: Blood in stool; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration on 15Apr2021 at 12:00 AM (at the age of 36-years) as single dose for COVID-19 immunisation. The patient received vaccine at a pharmacy or drug store. The patient has no medical history and no concomitant medications. The patient has no known allergies. The patient has no other vaccine in four weeks. The patient has no covid prior vaccination. Covid was not tested post vaccination. The patient experienced blood in stool on 15Apr2021 at 01:00 PM with outcome of recovering. The patient did not receive treatment for the adverse event.  Information on the lot/batch number has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Chest pain, Cough, Dysphonia, Dyspnoea
Clinical narrative: She feels she has a cold in her chest; cold; influenza A; Hacking cough; voice affected; chest burning; Difficulty breathing; chest congestion; This is a spontaneous report from a contactable consumer. This 74-year-old female consumer reported that she started to receive the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL9266) via an unspecified route of administration in arm left on 03Mar2021 08:45AM (at the age of 74-year-old) at single dose for COVID-19 immunisation. First dose of BNT162b2 (Lot number GM or EM9809) was taken on 10Feb2021 (at the age of 74-year-old) in left arm (way up high on the shoulder) for COVID-19 immunisation. Relevant medical history included bronchitis, chronic obstructive pulmonary disease (due to environmental toxins), allergy to different dyes (allergic to yellow, purple, and blue dye) and allergy to medications. The patient has never been a drinker or smoker. Concomitant medications were not reported. A week or so after the second dose, she thought she was having a cold. It has affected her voice and breathing. She thought she had bronchitis.  She was going to her doctor on 04May2021. She had a hacking cough and she doesn't know what she has if it isn't a cold. She wondered if it was connected to the vaccine or is it bronchitis. The more she talks the more difficulty in her chest. She was prescribed Robitussin DM cough syrup by her doctor and was taking honey lemon cough drops. She also had congestion in her chest ever since. She has been having like a cold in her chest. It was heard how she was sounding. She never thought it was connected to the vaccine and never expected this to last for this long. The patient asked whether it could be a residual side effects of the vaccine and questioned if this could have had any effect on the COPD. She stated she was not having any problems with it and she has had it for years. Her cough has been the same, she takes a dose of DM cough syrup or a cough drop during the day. Robitussin was working. She was drinking lots of fluids, between 74-96 ounces of water per day. The doctor told her she had A influenza, but she thought she had COVID because she had all the symptoms, but they said A influenza and treated her for influenza A. That morning she had difficulty breathing like bronchitis, her chest was burning inside and was always like that, her talking aggravates everything and she had deep breathing. Her physician said her chest was clear after she thought she had bronchitis at her previous visit. She does not have any questions, she was calling to report an event, she is calling her doctor for further guidance. Cough, difficulty breathing, voice changed required a visit at physician office. Onset date for hacking cough, voice affected, chest burning, difficulty breathing and chest congestion was 10mar2021, while onset date for the other events was unknown. Hacking cough, voice affected, chest burning, difficulty breathing and chest congestion were not resolved, outcome of the other events was unknown.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis, Glossodynia, Neck pain, Pain in jaw
Clinical narrative: my face was paralyzed slightly due to Bell's palsy; my tongue had a sore; I got pain in my jaw and pain in my left side of my neck for about 3days; I got pain in my jaw and pain in my left side of my neck for about 3days; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EP7534) via an unspecified route of administration, administered on the left arm on 17Mar2021 13:00 at a single dose for COVID-19 immunisation. Medical history included Bell's palsy (prior case, 9 1/2 years ago). The patient's concomitant medications were not reported. On 21Mar2021 12:00 PM, within the 3rd day her tongue had a sore. It went away and she got pain in her jaw and pain in the left side of her neck for about 3days. Then, her face was paralyzed slightly due to Bell's palsy. It went away within a week and a half. Treatment was received for the events which included medication to help with Bell's palsy. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Patient was not pregnant. The facility where the vaccine was administered was in a Public Health Department. No known allergies. Outcome of the events was recovered on an unspecified date in 2021.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a contactable nurse. A 17-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced headache on an unspecified date with outcome of not recovered. The reporter seriousness for headache was medically significant.  Information about the Lot/batch number has been requested.; Sender's Comments: Based on the known product safety profile, a causal association between the reported event 'headache' and the suspect product BNT162B2 cannot be completely excluded. 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.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Dysstasia, Gait disturbance
Clinical narrative: severe pain in was my side sort of on my back thing; cannot walk with that pain; my side were it is almost impossible to stand up on a sitting position; This is a spontaneous report from a contactable consumer.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 07Apr2021 (Batch/Lot Number: Unknown) at single dose for COVID-19 immunisation.  Medical history included kidney cancer and kidney were removed 15 years ago. The patient's concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1, (lot number:EN6206) for COVID-19 immunisation.  The patient stated on 08Apr2021, "I had my second Pfizer shot on last Wednesday on 07Apr and Thursday morning I woke up and I am having severe pain in was my side sort of on my back thing, my side were it is almost impossible to stand up on a sitting position. I cannot walk with that pain and I just report it on, like through the whatever that portal is but it's been five days so, I don't know if I should go to the doctor or not or I should just wait it out. I did have kidney cancer and that exactly where it is hurting. I had kidney cancer, my kidney were removed 15 years ago. So, could it be like information from the shot?" The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.