chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Product administered at inappropriate site, Vaccination site pain
Clinical narrative: my injection was improperly given and not in the muscle; when she received the shot it was a "painful situation"; left shoulder discomfort; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), administration date 07Apr2021 (Lot number: EW0150) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Caller reports that she received her first vaccine dose on March 17th (Lot - EN6207)), administration date: 17Mar2021, reaction(s): "COVID-19 Immunization". The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious), outcome "unknown", described as "my injection was improperly given and not in the muscle"; VACCINATION SITE PAIN (non-serious), outcome "recovering", described as "when she received the shot it was a "painful situation""; MUSCULOSKELETAL DISCOMFORT (non-serious), outcome "unknown", described as "left shoulder discomfort".  Additional information: Caller reports that she received her first vaccine dose on March 17th (Lot - EN6207) and her 2nd vaccine dose 3 weeks later on April 7th (LOT- EW0150). Caller reports having no concerns with her first vaccine dose but reports that when she received her 2nd dose, she noticed that the person administering the vaccine rubbed the alcohol really high on her left shoulder. The caller reports that she mentioned to her "That felt kind of high" and when she received the shot it was a "painful situation". Caller now states "I believe my injection was improperly given and not in the muscle". Caller reports that afterwards she has had continuous left shoulder discomfort and decreased range of motion stating "I can't bring my arm to the side without discomfort" but reports that the pain s starting to lessen. She asks, "Was my shot effective as it was administered?. She reports that she has given a lot of information already but had no reference number to indicate her filing a report. Agreeable to transfer to and wait time  (3 calls ahead). Provided number for reference. Caller also reports that she already reported to Vaers. Response received confirmed Pfizer covid vaccine. Spoke from attached documentation. Referred to HCP for evaluation and guidance. Transferred to queue to file a report with number.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Pain, Pain assessment
Clinical narrative: 9.8 pain rating after receiving the first; Lupus acting up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date 20Mar2021 18:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Lupus" (unspecified if ongoing). Concomitant medication(s) included: NORCO taken for systemic lupus erythematosus; TRAMADOL taken for systemic lupus erythematosus. The following information was reported: PAIN (non-serious), outcome "unknown", described as "9.8 pain rating after receiving the first"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "Lupus acting up". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain.  Additional information: Caller (over 65 years old) calling regarding her daughter who had Lupus and had received her first dose of Pfizer COVID vaccine on 20Mar2021 and would be getting her second dose tomorrow, 10Apr2021. She was told by her doctor not to take methotrexate. She had a 9.8 pain rating after receiving the first shot, but the caller was not sure if it might have been due to the Lupus acting up. After the first dose at 6 pm, her daughter complained of a 9.8 rated pain, so the caller gave her Norco and offered Tylenol, but her daughter did not want to take Tylenol. What really helped her was the Diclofenac (Voltaren) gel, but it was only temporary relief. Caller states her daughter normally has Lupus in the morning and normally takes Norco or Tramadol in the morning. Caller was asking if it is ok for her daughter to take Norco or Tramadol in the morning when her second dose was scheduled in the afternoon at 2 pm Caller also asking if her husband should not take his Aspirin that he normally takes at night before he gets his vaccine Caller also asking if her husband could continue to take his blood pressure medication for his heart.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Aphonia
Clinical narrative: loss of  voice; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: APHONIA (non-serious), outcome "unknown", described as "loss of voice".  Additional Information: Additional Information: Consumer wants to know if losing voice is a side effect of the Pfizer-BioNTech Covid-19 Vaccine. She said this happened after the 1st dose of the vaccine. I told the consumer that there is no information about losing voice associated with the Pfizer-BioNTech Covid-19 Vaccine. I referred the consumer to her HCP for more guidance. This is a spontaneous report from a Pfizer- sponsored program  .A contactable female consumer (Patient) reported for herself that: It was unknown if the reporter a healthcare professional. : It was unknown if reporter's contact information available to you or a sub- contracted party. Reporter the prescribing was health care professional. Caller mentioned that after her first dose she experienced loss of voice. Caller would like to know if loss of voice is one of the side effects of the vaccine. Call transferred and manually created an adverse event form.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Pain in extremity, Vaccination site pain
Clinical narrative: she had some "arm pain"; pain in the injection site; period pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 20 year-old female patient received bnt162b2 (BNT162B2), administration date 08Apr2021 (Batch/Lot number: unknown) at the age of 20 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 08Apr2021, outcome "not recovered", described as "she had some "arm pain""; VACCINATION SITE PAIN (non-serious) with onset 08Apr2021, outcome "unknown", described as "pain in the injection site"; DYSMENORRHOEA (non-serious) with onset Apr2021, outcome "unknown", described as "period pain".  Additional information: She stated she had some "arm pain" However, she's on her period now. Can she take acetaminophen or ibuprofen acetaminophen or ibuprofen for her period for her period. The reporter is a consumer who received her first dose Pfizer Covid Vaccine yesterday, 08APR2021 and is wondering if she is allowed to take Ibuprofen or Acetaminophen. The reporter states she currently is on her period and wonders if she can use Acetaminophen or Ibuprofen for pain. The reporter clarifies the pain she is experiencing is from her period. The reporter reported she feels arm pain, but nothing drastic. States this arm pain occurred the same day she received the Pfizer Covid Vaccine first dose 08APR2021. The arm. pain began a couple hours after is still ongoing now. The reporter clarifies the pain she is experiencing is from her period. The reporter felt arm pain but nothing drastic. States this arm pain occurred the same day she received the Pfizer Covid Vaccine first dose 08APR2021. The arm pain began a couple hours after is still ongoing now. The reporter reports the arm pain is persisting. Clarifies, the arm pain is the same as yesterday. The reporter reports her period pain is really bad. The reporter received Pfizer Covid-19 vaccine first dose on 08Apr2021 and experienced pain in the injection site. 2nd dose will be on 29Apr2021. Wanted to know if she can take Ibuprofen or Acetaminophen.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site swelling
Clinical narrative: Sore arm; Swelling at shot site; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 73-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left (Batch/Lot number: unknown) at the age of 73 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Kidney issues" (unspecified if ongoing); "Cardiac issues" (unspecified if ongoing); "Known Allergies" (unspecified if ongoing), notes: Unspecified. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Sore arm"; VACCINATION SITE SWELLING (non-serious), outcome "recovered", described as "Swelling at shot site".  Additional Information: The patient received medications (unspecified) within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date, the patient experienced sore arm and swelling at shot site (vaccination site swelling). The clinical outcome of events sore arm and swelling at shot site was recovered on an unknown date with duration of 2 days.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021401349 Same patient and drug, different dose and events
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: After getting the injection a red mark appeared; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 2021, outcome "unknown", described as "After getting the injection a red mark appeared".  Additional Information: Caller got her 1st dose last week and after getting the injection a red mark appeared and she wanted to know why that would disappear. She stated it was not bothering her at all.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw, Sinusitis, Toothache, Trismus
Clinical narrative: left jaw hurt; couldn't open my mouth very far to eat; sinuses were swollen because my teeth also hurt in that area. Very painful.; sinuses were swollen because my teeth also hurt in that area. Very painful.; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 53 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 12Mar2021 10:30 (Lot number: EP6955) at the age of 53 years as dose 1, single for covid-19 immunization. Relevant medical history included: "slightly low thyroid" (unspecified if ongoing); "HBP" (unspecified if ongoing), notes: controlled with medications; "Dental work" (unspecified if ongoing), notes: done the week before. The patient took concomitant medications. The following information was reported: PAIN IN JAW (non-serious) with onset 13Mar2021 12:00, outcome "recovered" (2021), described as "left jaw hurt"; TRISMUS (non-serious) with onset 13Mar2021 12:00, outcome "recovered" (2021), described as "couldn't open my mouth very far to eat"; SINUSITIS (non-serious), TOOTHACHE (non-serious) all with onset 13Mar2021 12:00, outcome "recovered" (2021) and all described as "sinuses were swollen because my teeth also hurt in that area. Very painful.". The events "left jaw hurt", "couldn't open my mouth very far to eat" and "sinuses were swollen because my teeth also hurt in that area. very painful." were evaluated at the physician office visit. Therapeutic measures were not taken as a result of pain in jaw, trismus, sinusitis and toothache.  Additional information: On 13Mar2021 at 12:00 the patient experienced left jaw hurt, couldn't open mouth very far to eat almost as if jaw was locked up. The patient had dental work done the week before and was suspicious that sinuses were swollen because of teeth also hurt in that area and were very painful. The patient had not received any other vaccine within 4 weeks but had received medication within two weeks of vaccination. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient was not allergic to any medications, food or other products.  No follow-up attempts are possible. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fall, Gait disturbance, Nausea
Clinical narrative: severe vertigo; could hardly navigate; nauseated; throw up twice; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 85 year-old female patient received bnt162b2 (BNT162B2), administration date 26Mar2021 (Lot number: ER8730) at the age of 85 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Injury" (unspecified if ongoing), notes: cap path (as reported); prior to vaccination; "walker user" (unspecified if ongoing), notes: due to injury; prior to vaccination. The patient's concomitant medications were not reported. The following information was reported: VERTIGO (non-serious) with onset 01Apr2021 07:00, outcome "recovered" (01Apr2021 14:00), described as "severe vertigo"; GAIT DISTURBANCE (non-serious) with onset 01Apr2021 07:00, outcome "unknown", described as "could hardly navigate"; NAUSEA (non-serious) with onset 01Apr2021, outcome "unknown", described as "nauseated"; VOMITING (non-serious) with onset 01Apr2021, outcome "unknown", described as "throw up twice".  No follow-up attempts are possible. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Nausea, Vertigo, Vomiting
Clinical narrative: severe vertigo; could hardly navigate; nauseated; throw up twice; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 85 year-old female patient received bnt162b2 (BNT162B2), administration date 26Mar2021 (Lot number: ER8730) at the age of 85 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Injury" (unspecified if ongoing), notes: cap path (as reported); prior to vaccination; "walker user" (unspecified if ongoing), notes: due to injury; prior to vaccination. The patient's concomitant medications were not reported. The following information was reported: VERTIGO (non-serious) with onset 01Apr2021 07:00, outcome "recovered" (01Apr2021 14:00), described as "severe vertigo"; GAIT DISTURBANCE (non-serious) with onset 01Apr2021 07:00, outcome "unknown", described as "could hardly navigate"; NAUSEA (non-serious) with onset 01Apr2021, outcome "unknown", described as "nauseated"; VOMITING (non-serious) with onset 01Apr2021, outcome "unknown", described as "throw up twice".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pain, Pain in extremity
Clinical narrative: sick; body aches; sever arm pain/arm is hurting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 03Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 09Apr2021, outcome "not recovered", described as "sever arm pain/arm is hurting"; ILLNESS (non-serious), outcome "unknown", described as "sick"; PAIN (non-serious), outcome "recovering", described as "body aches". Therapeutic measures were taken as a result of pain in extremity, illness, pain.  Additional information: After consumer received the 2nd dose of the Pfizer-BioNTech Covid-19 Vaccine on 03Apr, she was sick and had body aches and a sore arm. Today, she woke up and it was worse, arm pain was severe and her arm was hurting. She also mentioned that she has been taking Advil, Tylenol to treat the symptoms, but said that she thought they are not working. Consumer wanted to know if this was a normal reaction to the vaccine and how long it lasts. Patient clarified she has body aches which was better and an achy arm which was now severe. Patient stated it was Pfizer for her eye surgery next week and she was an educator and needs it for work. Information regarding expiry date, other products, Investigation Assessment and patient history was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Groin pain, Pain in extremity, Tenderness
Clinical narrative: groin pain; she was dragging her legs because of the pain/tenderness; she was dragging her legs because of the pain/tenderness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 77 year-old female patient received bnt162b2 (BNT162B2), administration date 20Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GROIN PAIN (non-serious) with onset 20Mar2021, outcome "recovered" (20Mar2021), described as "groin pain"; PAIN IN EXTREMITY (non-serious), TENDERNESS (non-serious) all with onset 20Mar2021, outcome "recovered" (20Mar2021) and all described as "she was dragging her legs because of the pain/tenderness". Therapeutic measures were taken as a result of groin pain, pain in extremity, tenderness.  Additional information: The patient received her first dose on 20Mar2021 - she reports that immediately after getting the vaccine she experienced groin pain and by the time she got home and went to bed she was dragging her legs because of the pain/tenderness. The symptoms resolved the following day after taking pain relieving medication. She wants to know if this is reported side effect. Referred her to HCP for further discussion. Spoke from attached document FACT SHEET FOR HCPs ADMINISTERING VACCINE; FULL EUA PI (v1.0) (LAB-1457-7.0 Revised: 06 April 2021) section 6.1 Clinical Trials Experience. Response: Referred her to speak with husband's HCP for further guidance and treatment recommendations. Informed caller that Pfizer does not have information on concomitant use of medications with the covid vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Feeling abnormal, Feeling cold, Hyperhidrosis, Nausea
Clinical narrative: my arm was really sore; profusely sweating and then freezing; profusely sweating and then freezing; as white as a ghost; her body felt like a bag of bricks; Incredibly Nauseous; profusely puking/ Vomiting; I lost control of my bladder while I was puking/ had no control over her bladder and pee was coming out; diarrhea really bad; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 46 year-old female patient received bnt162b2 (BNT162B2), administration date 06Apr2021 14:30 (Batch/Lot number: unknown) at the age of 46 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: NAUSEA (non-serious) with onset 07Apr2021 01:20, outcome "unknown", described as "Incredibly Nauseous"; VOMITING (non-serious) with onset 07Apr2021 01:20, outcome "unknown", described as "profusely puking/ Vomiting"; URINARY INCONTINENCE (non-serious) with onset 07Apr2021 01:20, outcome "unknown", described as "I lost control of my bladder while I was puking/ had no control over her bladder and pee was coming out"; DIARRHOEA (non-serious) with onset 07Apr2021 01:20, outcome "unknown", described as "diarrhea really bad"; PAIN IN EXTREMITY (non-serious) with onset 08Apr2021, outcome "unknown", described as "my arm was really sore"; HYPERHIDROSIS (non-serious), FEELING COLD (non-serious) all with onset 07Apr2021 01:20, outcome "unknown" and all described as "profusely sweating and then freezing"; PALLOR (non-serious) with onset 07Apr2021 01:20, outcome "unknown", described as "as white as a ghost"; FEELING ABNORMAL (non-serious) with onset 07Apr2021 01:20, outcome "unknown", described as "her body felt like a bag of bricks".  Additional information: The patient did not have adverse event prior vaccination within 4 weeks and no family medical history relevant to adverse event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pallor, Urinary incontinence, Vomiting
Clinical narrative: my arm was really sore; profusely sweating and then freezing; profusely sweating and then freezing; as white as a ghost; her body felt like a bag of bricks; Incredibly Nauseous; profusely puking/ Vomiting; I lost control of my bladder while I was puking/ had no control over her bladder and pee was coming out; diarrhea really bad; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 46 year-old female patient received bnt162b2 (BNT162B2), administration date 06Apr2021 14:30 (Batch/Lot number: unknown) at the age of 46 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: NAUSEA (non-serious) with onset 07Apr2021 01:20, outcome "unknown", described as "Incredibly Nauseous"; VOMITING (non-serious) with onset 07Apr2021 01:20, outcome "unknown", described as "profusely puking/ Vomiting"; URINARY INCONTINENCE (non-serious) with onset 07Apr2021 01:20, outcome "unknown", described as "I lost control of my bladder while I was puking/ had no control over her bladder and pee was coming out"; DIARRHOEA (non-serious) with onset 07Apr2021 01:20, outcome "unknown", described as "diarrhea really bad"; PAIN IN EXTREMITY (non-serious) with onset 08Apr2021, outcome "unknown", described as "my arm was really sore"; HYPERHIDROSIS (non-serious), FEELING COLD (non-serious) all with onset 07Apr2021 01:20, outcome "unknown" and all described as "profusely sweating and then freezing"; PALLOR (non-serious) with onset 07Apr2021 01:20, outcome "unknown", described as "as white as a ghost"; FEELING ABNORMAL (non-serious) with onset 07Apr2021 01:20, outcome "unknown", described as "her body felt like a bag of bricks".  Additional information: The patient did not have adverse event prior vaccination within 4 weeks and no family medical history relevant to adverse event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased
Clinical narrative: The caller said that she took the 1st dose yesterday 08Apr2021, but she noticed that her blood sugar has been elevated last night and this morning; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), administration date 08Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Type 1 diabetes" (ongoing). Concomitant medication(s) included: METFORMIN; INSULIN. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious) with onset 09Apr2021, outcome "unknown", described as "The caller said that she took the 1st dose yesterday 08Apr2021, but she noticed that her blood sugar has been elevated last night and this morning". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient said that she took the 1st dose yesterday,08Apr2021, but she noticed that her blood sugar had been elevated last night and this morning. She also mentioned that she took Metformin and her insulin as she needed to take them every day. She Submitted a manual AE form. Unaddressed medical questions was referred or forwarded to Medical Information.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Mental disorder, Nightmare
Clinical narrative: he's been having psychotic effects, nightmares/ bad dreams; he's been having psychotic effects, nightmares/ bad dreams; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63 year-old male patient received bnt162b2 (BNT162B2), administration date 16Mar2021 (Batch/Lot number: unknown) as dose 1, single and administration date 06Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NIGHTMARE (non-serious), MENTAL DISORDER (non-serious) all with onset 2021, outcome "unknown" and all described as "he's been having psychotic effects, nightmares/ bad dreams". Additional information: It was reported that the patient who was currently taking Keppra, received both doses of the Pfizer BioNTech Covid 19 vaccine, the first dose on 16Mar2021, and the second was on 06Apr2021. Since the first dose he had been having psychotic effects, nightmares/ bad dreams.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Malaise, Pain in extremity, Vertigo
Clinical narrative: lost her balance; had the sensation of her head spinning around; Today she stopped feeling pain in her arm and was able to drive; when she was sitting she stopped feeling the malaise but when she stood up she felt the malaise again; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 07Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BALANCE DISORDER (non-serious) with onset Apr2021, outcome "unknown", described as "lost her balance"; VERTIGO (non-serious) with onset Apr2021, outcome "unknown", described as "had the sensation of her head spinning around"; PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "Today she stopped feeling pain in her arm and was able to drive"; MALAISE (non-serious) with onset Apr2021, outcome "unknown", described as "when she was sitting she stopped feeling the malaise but when she stood up she felt the malaise again".  Additional information: Patient received the first dose of the vaccine the day before yesterday (April 7th), during the night she woke up to go to the bathroom and lost her balance on two occasions (2 hours in between each event) she had to lean on a wall to avoid falling down, when she was sitting she stopped feeling the malaise but when she stood up she felt the malaise again, in the morning she had the sensation of her head spinning around. Today she stopped feeling pain in her arm and was able to drive. She wants to know if this is normal and if she should receive the second dose of the vaccine. Patient declined to get transferred to a HCF. During the call she mentioned that she went to sleep leaning her body against her shoulder where she received the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain, Peripheral swelling
Clinical narrative: Arm is still swollen; Headaches; Achy body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "arm is still swollen"; HEADACHE (non-serious), outcome "unknown", described as "headaches"; PAIN (non-serious), outcome "unknown", described as "achy body".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Breast mass, Fatigue, Feeling abnormal, Feeling hot
Clinical narrative: soreness on the left arm; lump between breast and armpit left arm; tiredness; redness of the injection site; Wasn't feeling great; Knot or ball between armpit and breast, on the same side as injection, left; Knot or ball between armpit and breast, on the same side as injection, left; Soreness on arm, can't lift it; Injection site pain; Feeling hot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Apr2021 13:15 (Lot number: ER8733, Expiration Date: Jul2021) at the age of 52 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 07Apr2021 17:00, outcome "not recovered", described as "soreness on the left arm"; MASS (non-serious) with onset 07Apr2021 17:00, outcome "not recovered", described as "lump between breast and armpit left arm"; FATIGUE (non-serious) with onset 07Apr2021 17:00, outcome "not recovered", described as "tiredness"; VACCINATION SITE ERYTHEMA (non-serious) with onset 07Apr2021 17:00, outcome "not recovered", described as "redness of the injection site"; FEELING ABNORMAL (non-serious) with onset 07Apr2021 17:00, outcome "not recovered", described as "Wasn't feeling great"; BREAST MASS (non-serious), AXILLARY MASS (non-serious) all with onset 07Apr2021 17:00, outcome "not recovered" and all described as "Knot or ball between armpit and breast, on the same side as injection, left"; MOBILITY DECREASED (non-serious) with onset 07Apr2021 17:00, outcome "not recovered", described as "Soreness on arm, can't lift it"; VACCINATION SITE PAIN (non-serious) with onset 07Apr2021 17:00, outcome "not recovered", described as "Injection site pain"; FEELING HOT (non-serious) with onset 07Apr2021 17:00, outcome "not recovered", described as "Feeling hot".  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Mobility decreased, Pain in extremity, Vaccination site erythema, Vaccination site pain
Clinical narrative: soreness on the left arm; lump between breast and armpit left arm; tiredness; redness of the injection site; Wasn't feeling great; Knot or ball between armpit and breast, on the same side as injection, left; Knot or ball between armpit and breast, on the same side as injection, left; Soreness on arm, can't lift it; Injection site pain; Feeling hot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Apr2021 13:15 (Lot number: ER8733, Expiration Date: Jul2021) at the age of 52 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 07Apr2021 17:00, outcome "not recovered", described as "soreness on the left arm"; MASS (non-serious) with onset 07Apr2021 17:00, outcome "not recovered", described as "lump between breast and armpit left arm"; FATIGUE (non-serious) with onset 07Apr2021 17:00, outcome "not recovered", described as "tiredness"; VACCINATION SITE ERYTHEMA (non-serious) with onset 07Apr2021 17:00, outcome "not recovered", described as "redness of the injection site"; FEELING ABNORMAL (non-serious) with onset 07Apr2021 17:00, outcome "not recovered", described as "Wasn't feeling great"; BREAST MASS (non-serious), AXILLARY MASS (non-serious) all with onset 07Apr2021 17:00, outcome "not recovered" and all described as "Knot or ball between armpit and breast, on the same side as injection, left"; MOBILITY DECREASED (non-serious) with onset 07Apr2021 17:00, outcome "not recovered", described as "Soreness on arm, can't lift it"; VACCINATION SITE PAIN (non-serious) with onset 07Apr2021 17:00, outcome "not recovered", described as "Injection site pain"; FEELING HOT (non-serious) with onset 07Apr2021 17:00, outcome "not recovered", described as "Feeling hot".  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia, Malaise, Myalgia, Paraesthesia
Clinical narrative: feeling "unwell"; Fatigue/tiredness/total fatigue was reported as worsened; muscle pain; right arm went numb and then started getting a tingling all through caller's body; right arm went numb and then started getting a tingling all through caller's body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 08:00 (Lot number: EN6205) at the age of 67 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Lot EL9267, Time the Vaccination Was Given: close to 0800, Anatomical Location: left arm), administration date: 12Feb2021, for COVID-19 immunization; Flu shot, reaction(s): "feels like getting the flu", "caller feels body aches from it". The following information was reported: MALAISE (non-serious) with onset 06Mar2021, outcome "unknown", described as "feeling "unwell""; FATIGUE (non-serious) with onset 06Mar2021, outcome "not recovered", described as "Fatigue/tiredness/total fatigue was reported as worsened"; MYALGIA (non-serious) with onset 06Mar2021, outcome "unknown", described as "muscle pain"; HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious) all with onset 06Mar2021, outcome "unknown" and all described as "right arm went numb and then started getting a tingling all through caller's body".  Additional information: No Prior Vaccinations (within 4 weeks). The patient did not visit emergency room or Physician office.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: He said there was an increase in his tinnitus.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 21Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Tinnitus" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "He said there was an increase in his tinnitus."  Additional information : Consumer said he received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine and is scheduled to receive the 2nd dose in 2 days, this Sunday. However in the last week, he said he noticed a change in the condition that he had which is tinnitus. He said there was an increase in his tinnitus. He also noted that it is not severe and did not bother him that much. Consumer wants to know if this is related to the vaccine. The patient already received his 1st dose of Pfizer Covid-19 vaccine last March 21 and is scheduled to have his 2nd dose on April 11. However, he had a health issue as there was an increase in his Tinnitus a week ago. He had it previously however he wonders if the increase in his Tinnitus was caused by the vaccine. He would also like to know if there are reports with the Covid-19 vaccine affecting Tinnitus related conditions.   Follow-up(09Apr2021): This is an Spontaneous report from regulatory authority of a contactable consumer. This consumer (patient) reported for himself.  No follow-up attempts are needed. No further information is expected.  Follow-up(13APR2021): This is follow-up spontaneous report from contactable consumer. No  information received.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Fatigue, Feeling abnormal, Pain in extremity, Tinnitus
Clinical narrative: this increasingly became worse; he noticed it more and thought it was was weird; a slight ringing in his ears; Little tired next day; Right arm soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 24Mar2021 12:00 (Lot number: ER8727, Expiration Date: 31Jul2021) at the age of 61 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Pfizer COVID vaccine 03 Mar 2021, Lot EN6205, Expiration 30 Jun 2021. 0.3ml dose. Injected in right arm in the muscle.), administration date: 03Mar2021, for Covid-19 immunization. The following information was reported: TINNITUS (non-serious) with onset 26Mar2021 12:00, outcome "not recovered", described as "a slight ringing in his ears"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "this increasingly became worse"; FATIGUE (non-serious) with onset 25Mar2021 12:00, outcome "recovering", described as "Little tired next day"; PAIN IN EXTREMITY (non-serious) with onset 25Mar2021, outcome "recovering", described as "Right arm soreness"; FEELING ABNORMAL (non-serious) with onset 28Mar2021, outcome "unknown", described as "he noticed it more and thought it was was weird".  Additional information: Patient had second dose and 2 days later he had ringing in the ears and as the days went on this increasingly became worse. Right arm soreness at middle of night and early in the morning and then it went away. Patient went to see an audiologist and was calling to see what type of information Pfizer has regarding this. He knows it was not common. He did not have any ringing prior to having the second Pfizer COVID vaccine. If he would have known this would happen, he would not have gotten it. The patient stated that some days the ringing was in one or the other ear. Some days it was in both. On 28Mar2021 patient was noticed it more and thought it was weird. Some days it was worse than others. By Sunday after the vaccine, it was worse for ringing in ears. This all just came about from the vaccine. It may have been psychological for tiredness. He said it was not bad. He has not had a vaccine in 20 years or longer. No ER or physician's office required. He went to an audiologist on 30Mar2021. They just did a check up and no medication offered. He heard people got steroids, but he did not. Reporter seriousness for events were unspecified. The patient did not administered any other products. Prior Vaccinations patient was received 1st COVID vaccine within 4 weeks.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Head discomfort
Clinical narrative: slight lightheadedness; she felt "pressure" in her head which resolved shortly after; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 87 year-old female patient received bnt162b2 (BNT162B2), administration date 07Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for covid-19 immunization. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "slight lightheadedness"; HEAD DISCOMFORT (non-serious), outcome "recovered", described as "she felt "pressure" in her head which resolved shortly after".  Additional Information: Consumer (57 y/o male) states he received his first Pfizer Covid vaccine on 07APr2021. He has a history of obesity, hypertension, asthma, and bronchitis. Consumer states his 87 y/o mother received her second dose on 07April2021. She experienced slight lightheadedness, but not dizziness, she felt "pressure" in her head which resolved shortly after.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Glycosylated haemoglobin abnormal
Clinical narrative: had "abnormally high reading of A1c" a week; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2,single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GLYCOSYLATED HAEMOGLOBIN ABNORMAL (non-serious), outcome "unknown", described as "had "abnormally high reading of A1c" a week".  Additional information: Reporter was asked if the vaccine could cause this abnormal HbA1c reading. patient then explained reporter "had done nothing different in the last 3 months". Patient later mentioned he  had "no repercussions/ no side effects" from both doses of the vaccine.  Unsuccessful warm-transfer attempt from (Privacy), no agent available.  reporter sated he'd prefer to be contacted back by phone if additional information is needed. E-transmitting AE.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Syringe issue
Clinical narrative: I don't know that I got the complete dose. The syringe popped when he took it out, it appeared to be some left in between the plunger and the needle; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2), administration date 20Mar2021 (Lot number: EP7534) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 (DOSE 1 (unknown manufacturer)), for COVID-19 immunisation. The following information was reported: SYRINGE ISSUE (non-serious) with onset 20Mar2021, outcome "unknown", described as "I don't know that I got the complete dose. The syringe popped when he took it out, it appeared to be some left in between the plunger and the needle".  Question: DSU: E-transmitting - Potential AE/PQC  The reporter question was the provider that gave him the shot, the patient noticed after he gave the shot there was a droplet that he smudged away, and the patient noticed in the syringe that there were droplets in the syringe. The patient did not know that he got the complete dose. The syringe popped when he took it out, it appeared to be some left in between the plunger and the needle.  No follow-up attempts are possible. No further information is expected.