chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A large blister formed at the injection site; Resting heart rate has decreased suddenly from about 70 bpm to 66 bpm.; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 29Mar2021 at 14:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have a history of allergies to medications, food, or other products. The patient did not receive any other medications within two weeks of COVID-19 vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Mar2021, the patient experienced a large blister formed at the injection site hours after the injection and was persisting 4 days afterwards, and her resting heart rate was also decreased suddenly from about 70 bpm to 66 bpm. The patient contacted her doctor (left a message), and was waiting to hear back about what to do. No therapeutic measures were taken as a result of the adverse events. The clinical outcome of the events large blister formed at the injection site and heart rate decreased was not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Nausea; Woozy feeling; Diarrhea; Headache; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 8733) via an unspecified route of administration in the left arm on 31Mar2021 at 14:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included bipolar disorder from an unspecified date. Concomitant medications included valproate semisodium (DIVALPROEX SODIUM), and quetiapine fumarate (QUETIAPIN) all from an unspecified date for bipolar disorder. The patient previously took hydrocodone; acetaminophen (VICODIN), diclofenac sodium (MANAFACTURER UNKNOWN), doxycycline hyc (MANAFACTURER UNKNOWN) all from an unknown date for an unspecified indication and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 15:00 the patient experienced nausea, woozy feeling, diarrhea, headache. The patient did not receive any treatment for the events. It was reported that she just began to feel a little better. She took a week to get the side effects gone. the sheet of symptoms said 1to 3 days. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events nausea, woozy, diarrhea, headache was resolving at the time of reporting.  No follow-up attempts are needed. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of rash in a 53-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included sulfur with an associated reaction of mass (sulfur drugs caused bumps between fingers). On 21st July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than 2 months after receiving SHINGRIX, the patient experienced rash and hives. The patient was treated with fexofenadine hydrochloride (Allegra) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the rash and hives were unknown. It was unknown if the reporter considered the rash and hives to be related to SHINGRIX. Additional details were provided as follows: This case was not previously reported to anyone. The patient received the vaccine on the right arm. The reporter reported that, she was experiencing patches of hives/rash that had been occurring off and on since received SHINGRIX but she could not recall the first date seen. The reporter stated that, they are located on her belly, groin, neck, back of thighs, arm pits and on her lower inner arm below the elbow. She had not notified to her physician. The reporter stated it was becoming more intense and more often. She noted taking Allegra and Benadryl and the issue gets resolved but it returns back.
Was given Moderna, 17yrs of age, vaccine is for 18 yrs and older
Pt had seizure on 5/29/14 while asleep husband states she was making noises and shaking violently. He could not wake her up. She bit her tongue noticed it was sore.
Lttle achy; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Lttle achy) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A, 003B21A and 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Lttle achy). At the time of the report, PAIN (Lttle achy) outcome was unknown.            Patient reported taking unspecified concomitant medications.  Patient had never tested positive for COVID. Patient received the Flu shot 1 week after receiving the booster dose.  No treatment medications were reported.
One hour after receiving the influenza vaccine at the doctor's office (08/28/2014) I returned home. Almost immediately I started having severe nausea and vomiting. I vomited at least three times. I also had body aches. This lasted for several hours. Today (08/29/2014) I am feeling fine.
maculopapular rash, w/irregular borders all over body; started @ inject site & redness over entire body;
Immediately upon administration, I experienced pain in the right arm and shoulder. As the day progressed, my whole right arm and shoulder became more and more painful. At one point, I was cradling my arm- any movement caused SEVERE discomfort. Over the next few days, I was unable to raise my arm over my head. I could not undress myself. As the weeks passed, the pain  slightly improved, but I'm still unable to  carry out basic activities of daily living without pain. When I sleep on my right side I wake up in excruciating pain. Picking up my daughter causes pain.
Drug ineffective; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 47-year-old male patient received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EL3247), on 16Mar2021 as dose 2, single (Lot number: EL3247) and on 26Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 46 years for covid-19 immunisation. It was unknown if prior to vaccination the patient was diagnosed with COVID-19. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 06Jan2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset 06Jan2023, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jan2023) Positive, notes: Nasal Swab; (07Jan2023) Positive, notes: Nasal Swab; (06Jan2023) Positive; (07Jan2023) Positive. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: As per the available information the causality of the events drug ineffective and covid-19 with the suspect can not be ruled out completely.
I am a physician who was called away from seeing patients to attend this patient for this adverse event.  She apparently passed out shortly after receiving three immunizations (Td, hepatitis B, and hepatitis A).  When I entered the vaccine room, she had bilateral tonic-clonic (clenching and shaking) movements of both arms and forearms, her eyes were rolled upward, she was quite pale, and when the seizure stopped, both pupils were dilated and she was diaphoretic.  There was no history of fever.  Oxygen was administered by nasal cannula and the patient was placed on a gurney in our clinic to recover for several minutes.  During the seizure, she urinated on the chair where she was sitting.  There was no fall or trauma to the head (she remained in the chair during the entire seizure)
Red Injection Site about 3" round; Vomiting; Tired; nausea; Muscle Pain; Joint pain; Warm to the Touch Injection Site,Injection Site Not As Hot as it was Before; Not Eating; Swollen Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to the Touch Injection Site,Injection Site Not As Hot as it was Before), FEEDING DISORDER (Not Eating), VACCINATION SITE SWELLING (Swollen Injection Site), VACCINATION SITE ERYTHEMA (Red Injection Site about 3" round) and VOMITING (Vomiting) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Swollen Injection Site). On 04-May-2021, the patient experienced VACCINATION SITE WARMTH (Warm to the Touch Injection Site,Injection Site Not As Hot as it was Before), FEEDING DISORDER (Not Eating), VACCINATION SITE ERYTHEMA (Red Injection Site about 3" round), VOMITING (Vomiting), FATIGUE (Tired), NAUSEA (nausea), MYALGIA (Muscle Pain) and ARTHRALGIA (Joint pain). At the time of the report, VACCINATION SITE WARMTH (Warm to the Touch Injection Site,Injection Site Not As Hot as it was Before) was resolving, FEEDING DISORDER (Not Eating), VACCINATION SITE SWELLING (Swollen Injection Site), VACCINATION SITE ERYTHEMA (Red Injection Site about 3" round), FATIGUE (Tired), NAUSEA (nausea), MYALGIA (Muscle Pain) and ARTHRALGIA (Joint pain) had not resolved and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment information not provided.
11/07/2002 MMR right arm, 11/17/2002 noticed soreness at injection site. 11/19/2002 noticed redness with lumps to injection site 11/21/2002. Came to clinic to report reaction. Noted apprx. 1 1/2 diameter red area with lump under skin. Complains of pain/ itching at site. Benadryl cream applied. Benadryl 25 mg po given. Advised to see MD. insisted to call back. did not call. Have not been able to reach via phone. 11/7/02 MMR Rt arm. 11/17/02 noticed soreness at inj site. 11/19/02 noticed redness with lump to inj site. 11/21/02 came to clinic to report reaction. Noted approx. 1 1/2" dimater red area with lump under skin. Complained of pain/itching at site. Benadryl cream applied. Benadryl 25mg po. Adv. to see Md. Instruted to call back-did not call-have not been able to reach via phone.
PATIENT WAS GIVEN 0.5ML OF NOVAVAX 23/24 BEYOND THE USE DATE. VACCINE WAS FIRST PUNCTURED AROUND 430PM 10/12/23 AND WAS LEFT OUTSIDE OF THE FRIDGE AFTER 7PM 10/12/23 (CLOSING TIME). THERE WAS ONE DOSE REMAINING FROM THIS EXPIRED VIAL AND  UNFORTUNATELY THE PATIENT WAS ACCIDENTALLY GIVEN THE LAST DOSE FROM THIS VIAL (PHARMACIST ERROR). NOVAVAX WAS IMMEDIATELY CONTACTED FOR STABILITY INFORMATION FOR BEYOND USE DATE OVER 12 HOURS AND PATIENT WAS INFORMED OF THE ERROR. PATIENT DID NOT REPORT ANY DISCOMFORT OR ADVERSE REACTIONS. NOVAVAX REACHED BACK AND UNFORTUNATELY DOES NOT HAVE STABILITY INFORMATION BEYOND 12 HOURS OF FIRST PUNCTURE. THEY FOLLOW THE CDC RECOMMENDATION (APPENDIX B) WHICH IS: IF THE MANUFACTURER DOES NOT HAVE DATA TO SUPPORT THE STABILITY OF THE VACCINE, REPEAT THE DOSE IMMEDIATELY (NO MINIMAL INTERVAL). INFORMED PATIENT AND HE WOULD LIKE TO GET RE-VACCINATED IMMEDIATELY (SAME DAY).
LIGHT HEAD, HOT, DIZZY 3-5 MIN PUT HEAD BETWEEN KNEE
Flu-like symptoms on 1-30-2013 & unable to lift her left arm. Low grade temp. Severe joint pain on 1-31-2013 with pain level of a 10 on a scale of 1-10. Unable to work because of the incredible joint pain.
Approx one hour after receiving the flu vaccine, she noticed body itching, hot feeling. light headed.  After two hours, developed hives on left arm which was the arm of vaccination. Saw Dr. who recommended antihistamine. Pt took Benadryl. Felt better. Next day, still improving.
pt returned to office w/cough, SOB, perioral cyanosis, nasal flaring, resp 50, HR 120, lungs w/coarse sands bilat, hands & feet red w/hives;epi given & DPH;
pt recvd vax; 29oct94 arm swollen & red about 10 cm; lasting 4 days; itching also 29oct94;
Severe chills (shivering) which lasted about 25 minutes. Bouts came in waves which each succeeding bout shorter than the previous. This was followed by a moderate temperature which lasted (+/-) 4 hours. I feel fine today, 10/13/2009. Has never happened before.
rapid heartbeat; dizziness; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported similar events for 2 patients. This is the 2nd of the 2 reports. This consumer (patient's daughter) reported for a female patient that:  A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown), via an unspecified route of administration, administered on 24Mar2021 as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced rapid heartbeat, dizziness on 24Mar2021. Her mother also received the 1st dose of the Pfizer vaccine on Wednesday and experienced the same side effects as her and she was wondering if genetics could have played a part. The patient underwent lab tests and procedures which included heart rate: rapid. The outcome of events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021335221 Same reporter/drug/event, different patient.
Thirty mins post vaccination, pt developed nausea, vomited, felt feverish and dizzy (temp 97.5 deg. F); vital signs stable.
Fever and swelling redness seen in ER 10/4/05 7PM, instructed to give Benadryl and Motrin. 10/5/05 Seen in office 10/5/05 for cellulitis, placed on Augmentin ES. Did not show for follow up 10/7/05.
Since receiving the vaccine I have noticed that some foods taste different than they used to. Coca cola and artificial citrus flavors have a very chemical type taste.
A rash all over and pain, swelling in feet, knees and hands began Saturday evening and slowly began to resolve. Pt did not seek or require medical treatment. Pain was moderate to severe.
Pneumovax administered 11/07/2002. Right deltoid. Within 4 hours-local reaction of erythema, swelling proceeding distally- increasing over 72 hours. treated with Commenes, Benadryl, and Keflex.
3 seizures approx 30 mins p/vax MD relates sz to DTP; pt eval by ER MD @ hosp;
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium, Systemic: Shakiness-Medium
I had gone shopping after the vaccine appointment because patient fell asleep in her infant carrier. At the shopping store I used the family restroom so I could watch her. After using the restroom I flushed the toilet. Patient awoke in full body seizures (the drs refer to them as tremors). Her entire body was shaking and it was the first time she's ever done that, ever! Her arms were simultaneously going up and down in large, stiff movements. Her head was shaking with smaller jerky and look in her eyes seemed to be one of terror. I did not time event (that was not my concern at the time) but I'd say the event lasted 2 minutes.  The episodes continued and she would wake up from naps the same way for weeks. She still has the seizures though not to same extent at all.
Patient tested COVID-19 positive twice > 2 weeks after completing her COVID-19 vaccine vaccination.
Allergic reaction, lots of itching; Allergic reaction, lots of itching; Allergic reaction, lots of itching Puffy swelling of eyes a week after vaccine; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 04Mar2021 at 16:00 (at the age of 43-years-old), as a single dose for COVID-19 immunisation. The patient's medical history included hypertension and allergies to environmental conditions. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included cetirizine hydrochloride (ZYRTEC) for allergy, hydrochlorothiazide (MANUFACTURER UNKNOWN) for an unknown indication and norethisterone (MINI PILL) for an unknown indication, all from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), in the right arm on an unspecified date for COVID-19 immunisation. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 10Mar2021 at 18:00, the patient experienced allergic reaction. The patient had lots of itching and puffy swelling of eyes a week after vaccine. The events required a visit to the doctor office; however, the patient did not receive any treatment for the adverse events. The clinical outcomes of allergic reaction lots of itching and puffy swelling of eyes were unknown.   No follow-up attempts are possible; information about lot number cannot be obtained.
Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. Information regarding the concurrent condition and medical history was not reported. On 02-MAY-2016 the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot # L051102 with expiration date of 17-JUN-2017, dose and route unknown). No adverse effect was reported. Additional information has been requested.
This spontaneous report as received from a physician assistant refers to a 85 years old male patient with high cholesterol, high blood pressure and glaucoma and prostate issue. The patient was vaccinated intramuscularly with 0.5 ml PNEUMOVAX 23 (lot# reported as H013847, exp 15-MAR-2014) on 15-NOV-2012. Concomitant medications included: FLOMAX, unspecified cholesterol med and unspecified blood pressure medicine. On 16-NOV-2012 the patient experienced cellulitis in the same left arm (hospitalization and life threatening). The patient sought medical attention. The patient was admitted at least for one day in Hospital and KEFLEX was given for the treatment. The outcome of the adverse event was unknown. Additional information has been requested.
No further AE's reported; Expired dose of MMRII given yesterday; This spontaneous report was received from a pharmacist technician referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 20-JAN-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) 0.5 milliliter, lot number T000890, expiration date 08-JAN-2022 (route of administration not reported) for prophylaxis (expired product administered). The vaccine was dilute with sterile diluent 0.5 milliliter lot number T004403, expiration date 13-OCT-2022. No adverse event was reported.
Developed fever of 99 to 101 for 8 days; muscle aches, upper back pain, cough
Pt. started with itching in face then in arms, presented with an erythematous rash 15 mins after inj. Tx: BENADRYL 50 mgs plus KENALONG 40 1cc.
Brief Syncopal episode immediately following vaccine administration. Patient regained consciousness within 30 sec. she had some sweating immediately following but no other symptoms.  Medical and EMS responded. BP 98/50 P 70 Patient has a history of syncope when ever she gets a shot.
Injection site had bumps; A few red spots around the injection site/a large red spot around the injection site; A few red spots around the injection site/a large red spot around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Injection site had bumps), VACCINATION SITE ERYTHEMA (A few red spots around the injection site/a large red spot around the injection site) and VACCINATION SITE RASH (A few red spots around the injection site/a large red spot around the injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, the patient experienced VACCINATION SITE ERYTHEMA (A few red spots around the injection site/a large red spot around the injection site) and VACCINATION SITE RASH (A few red spots around the injection site/a large red spot around the injection site). On 24-Jun-2021, the patient experienced VACCINATION SITE MASS (Injection site had bumps). At the time of the report, VACCINATION SITE MASS (Injection site had bumps), VACCINATION SITE ERYTHEMA (A few red spots around the injection site/a large red spot around the injection site) and VACCINATION SITE RASH (A few red spots around the injection site/a large red spot around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. No treatment information was reported
Information has been received from a physician concerning a 25 year old female with no pertinent medical history or drug reactions/allergies, who on 24-MAY-2007 was vaccinated with a first dose of Gardasil (lot# 657737/0522U) 0.5 mL IM. Concomitant therapy included Effexor and NuvaRing. Since the vaccination on 24-MAY-2007, the patient has been experiencing headaches on a daily basis. Medical attention was sought. On 25-JUL-2007, the patient received a second dose of Gardasil (lot#658222/0927U). On 26-NOV-2007, the patient received a third dose of Gardasil vaccine (lot#unknown). The patient experience syncope when she arrived home on the same day and once the next day, 27-NOV-2007. The patient has an appointment with her primary physician and a scheduled magnetic resonance imaging test for 29-NOV-2007. No further information was available. At the time of reporting it was unknown if the patient had recovered. The patient has not recovered from the headaches. Additional information has been requested.