chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hearing loss; Tinnitus; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient (not pregnant at time of vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 03May2021 16:45 (Lot Number: ER8730) as single dose (at the age of 50-years-old) for COVID-19 immunization. Medical history included asthma, migraine, and back pain. The patient had no known allergies. The patient's concomitant medications were not reported. The patient experienced tinnitus/hearing loss. Got the shot on 03May2021 and it started right before leaving the facility, reported it to the staff. Started out mild and has gotten progressively worse each day. Adverse event start date started on 03May2021 05:00 PM. No treatment received for adverse events. The outcome of the events was not recovered. Reporter did not consider events as serious. Facility where the most recent COVID-19 vaccine was administered was Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Device Date : 24May2021  Information on lot/batch number was available. Additional information has been requested.
MEMORY ISSUES; CAN NOT SEEM TO GET JOB DONE WITHOUT HESITATION/COULD NOT RETURN TO WORK TILL MARCH; DRAINED; CAUGHT COVID; MENSTRUATION NON STOP TILL FEB (FEBRUARY); This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient's pre-existing medical conditions included: Patient work at a clinic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on DEC-2021 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On DEC-2021, the patient experienced menstruation non stop till feb (february). On JAN-2022, the patient experienced caught covid. On an unspecified date, the patient experienced memory issues, can not seem to get job done without hesitation/could not return to work till march, and drained. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from menstruation non stop till feb (february) on FEB-2022, and the outcome of drained, caught covid, memory issues and can not seem to get job done without hesitation/could not return to work till march was not reported. This report was non-serious.
patient had received one dose of ADACEL on Friday 26-Aug-2022 and then received an extra dose of ADACEL as patient came for more vaccinations on Monday (29-AUG-2022) but was given another dose of ADACEL by accident with no reported adverse event; patient had received one dose of ADACEL on Friday 26-Aug-2022 and then received an extra dose of ADACEL as patient came for more vaccinations on Monday (29-AUG-2022) but was given another dose of ADACEL by accident with no reported adverse event; consumer received ADACEL due to being behind on vaccinations and the catch-up schedule calls for ADACEL with no reported adverse event; Initial information was received on 29-Aug-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 7 years old female patient who had received one dose of diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] on Friday (26-aug-2022) and then received an extra dose of Adacel as patient came for more vaccinations on Monday (29-aug-2022) but was given another dose of Adacel by accident with no reported adverse event, received Adacel due to being behind on vaccinations and the catch-up schedule calls for Adacel with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Aug-2022, the patient received a dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine (strength, formulation, dose, route, batch number and expiry date: unknown) in unknown administration site, Further On 29-Aug-2022 patient had received a another dose of the same vaccine at the dose of 0.50 ml once (strength: standard, formulation, route, batch number and expiry date: unknown) in unknown administration site all for prophylactic vaccination.  It was reported that On 26-Aug-2022, the patient had received Adacel due to being behind on vaccinations and had the  catch-up schedule calls (Inappropriate schedule of product administration) (latency: same day). Further reported that the patient had received an extra dose of Adacel described as the patient came in for more vaccinations on 29-Aug-2022) (Monday) but was given another dose of Adacel by accident (Wrong product administered) (extra dose administered) (latency: 3 days).  No adverse event was reported.  No lab data was reported.  Action taken: not applicable  Outcome: unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt had high pitched cry for an hour off & on; Also had 3-4 brief episodes (few seconds) of generalized stiffening w/o color change or other sz activity;
Body ache; Fever about 100; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) at a single dose, with therapy date and route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had body ache and fever at about 100 (unit was not reported). The outcome of the events, 'body ache' and 'fever', was unknown. The patient wanted to know if he could get his second dose, or if he has to start over.  Information on the lot/batch number has been requested.
pain in her arm; a burning sensation; she checked under her arm pit and she had two bumps that were really painful; bumps on her breasts that are really swollen.; bumps on her breasts that are really swollen.; she cannot breath; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Caller stated that yesterday she had the second dose of the Pfizer COVID-19 vaccine and she was starting to have symptoms. On an unspecified date she had a pain in her arm and a burning sensation as well. She stated that she checked under her arm pit and she had two bumps that were really painful and bumps on her breasts that were really swollen. She stated that her left arm was really aching as well. She stated that she had all these symptoms after the first dose from the first day. She stated that the symptoms just went away three days ago on 23Aug2021. She stated that the pain in her arm and in her breast was really bad. She stated that she felt like she cannot breath and if she took a breathe she had pain in her breast. She also stated she felt like she had tachycardia. Therapeutic measures were taken as a result of pain in her arm and she checked under her arm pit and she had two bumps that were really painful as she stated that someone told her to take 800 mg of Tylenol after getting the shot but the Tylenol didn't even take away 5 percent of the pain. The outcome of event she can not breathe was unknown while it was resolved for all other events on 23Aug2021.  No follow-up attempts are needed; information about lot/batch number can not be obtained.
Vaccine was administred at 1:30 PM. patient begain experiencing dizzness and sweating excessively after 15 minute obervation  1:55 PM Vitals were obtained Spo2: 92%  Pulse : 76 BP: 115/78 mmhg Pulse: 76. Patient assessed by Dr. Per Dr. provided gatarade for hydration and monitored additional (15) minutes. After 15 minutes Vitals were obtained: 02:15 PM BP: 120/87  mmhg Pulse: 77 Spo2: 100%. Symptoms were relieved per patient. Per Dr. release home . Patient advised if symtpons persist may go to emergency room for further evaluation. patient verbalized understanding and agreed
Did not feel well when he woke up on 4/21/16 around 1:pm. This is a 16-year-old boy who suffers from migraine headaches. Yesterday, he did not feel well when he woke up then around 1:00 p.m., he got migraine headaches and pain in the arms at the site of shots. He received the 16 year immunization prior 2 days, he received HPV and meningococcal vaccine then when he returned home, he did not feel like eating, he did not feel that good, but wanted to go to his basketball practice, so he went and then he started to feel even worse. Mother saw him, flushed in face and he was weak, could not even walk. She took him to Emergency Room, he fainted in the parking lot. Then he was in Emergency Room, he got p.o. BENADRYL, 10 and 15 minutes later, he could not breathe, his throat felt swollen and he got some rash on the neck, so he was given epinephrine shot. After that, CT of head was done and was normal and his urine drug screen was normal. CBC and CMP were showing normal and after that, he was admitted to pediatrics for further evaluation and treatment.
pt recvd vax & did not devel a titer p/8wk;MD reported approx 14 patients;pts assigned WAES95081597 & 95081815 through 95081827;
Extreme pain in the injection site unable to move arm and flu like symptoms (weakness, tiredness, cold and sweating through the sheets) No fever. Woke up on Monday 3/29, flu like symptoms gone, arm pain mostly subsided.
Pain Swelling. Shot administered in left arm- severe pain to the point where arm still cannot be used or lifted 30 hours later continued pain three days not getting better.
lump under his armpit on same arm that he got the shot in; lump under his armpit on same arm that he got the shot in; swollen lymph nodes (lymphadenopathy); Chills; Fever; This is a spontaneous report from a contactable consumer or other non hcp. A 19-years-old male patient received second dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: EW0157), via an unspecified route of administration, on 21Apr2021 at 10:30, administered in Arm Right as single dose for covid-19 immunisation. Patient's first dose of bnt163b2 (BNT162B2, Batch/lot number: ER8733) was administered on 31Mar2021 at 10:30 in left arm. The patient's concomitant medications were not reported.  On 21Apr2021 the patient experienced fever (08:00), chills (thinks around 21:00 or 22:00). She says on 21Apr2021, the same day as his second dose, he took ibuprofen. The dose was 300mg or 400mg and he took a total of 3 doses. She does not know the NDC number, lot number, or expiration date of the ibuprofen he took. On 23Apr2021 lump under his armpit on same arm that he got the shot in. On 23Apr2021 swollen lymph nodes. Prior Vaccinations within 4 weeks were none. The patient was not sick at the time of either vaccination. There was no family history. The outcome for events fever and chills were recovered on 22Apr2021 but for event lump under his armpit on same arm that he got the shot in was unknown.  No follow-up attempts are needed. No further information is expected.
Hospitalization: 1/20/2023 - 1/22/2023 (2 days) Presentation to the ED: syncopal episode COVID + date: 1/20/2023 Treatment: no treatment required. Discharge to: HOME.   EN6200 3/1/2021 EN6199 3/23/2021
one dose of undiluted vaccine, 0.2ml, was administered; one dose of undiluted vaccine, 0.2ml, was administered; Arm pain; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) for a Pfizer sponsored program.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 08Jan2022 (Lot number: FL0007, Expiration Date: 21Feb2022) as dose number unknown, 0.2 ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious) all with onset 08Jan2022, outcome "unknown" and all described as "one dose of undiluted vaccine, 0.2ml, was administered"; PAIN IN EXTREMITY (non-serious) with onset Jan2022, outcome "unknown", described as "Arm pain".  Additional information: it was reported that an event in which the vaccine was administered undiluted and was looking for recommendations and guidelines in that situation. Reporter clarifies that one dose of undiluted vaccine, 0.2ml, was administered 3 times, to 3 different patients. Reporter reported that he has spoken to the patients parents.   No follow-up attempts are possible. No further information is expected.
No adverse event to report.  Reporting an adminstration error.  Error in dilution. Pfizer Bivalent Orange Cap was diluted with 1.3mL sterile water instead of 1.3ml sodium chloride. Patient was given correct dose (0.2mL).
Within the 15 minute waiting period after vaccination I experienced a dull pain from my shoulder to my neck. Later in the evening my arm started to get sore as I expected and assumed it was all related. However after about 3 days the sore arm wore off but my shoulder pain continued. The pain is in my joint, more to the front of my shoulder and aches often because it is in my right arm and I am dominant in that arm. I have trouble reaching up or moving my shoulder at times without feeling a "pinch" or "pop", and my shoulder feels fatigued, almost like dead weight. I kept thinking it would eventually get better but at 3 weeks now it has not. I spoke with my employee health nurse and was advised to see my primary care physician and file this report.   In addition to the ongoing shoulder pain, I did experience a few days of heart fluttering and mild chest pain. I felt very anxious and could not sleep one night due to the feeling and had to call out from work.
Per tel. conversation, pt came in to imms. to turn in paperwork. When they noticed redness on his left side. Was immed seen by a provider, gave IV - drip of SOLUMEDROL, monitored and was released with inst. of to go to ER if sx worsen and SOB. Gave Epi Pen as needed. TWINRIX was given as subs for Hep B due to shortage.
Information has been received from a registered nurse and a certified medical assistant concerning a 16 year old female with migraine headaches and allergy to cephalosporin who on 27-JUL-2009 was vaccinated with a 0.5 ml IM first dose of GARDASIL (lot no. 661953/1130X). No other vaccines were given that day. Concomitant therapy included ORTHO EVRA. On 28-JUL-2009 the patient stated she developed a rapid heart rate "it feel like it was rushing out of my chest", standing cause her to loose her breath and dizziness. The symptoms continued through the entire day and into the next. On 29-JUL-2009 the patient was seen at emergency room and was diagnosed with supraventricular tachycardia (SVT) with a heart rate of 200 (bmp). The patient was not hospitalized. The patient underwent cardioversion and was released with heart rate in the 90's (sinus rhythm). On an unspecified date, the patient recovered from supraventricular tachycardia. A blood work and a electrocardiogram (EKG) was performed (results not reported). The patient is being followed by a cardiologist and another physician who reported that holter monitor results were "fine." The reporter stated that supraventricular tachycardia was not related to therapy with GARDASIL. Supraventricular tachycardia was considered to be life threatening an other important medical event. A lot check has been initiated. No further information is available.  8/28/09 ER records received DOS 7/29/09. Assessment: Arrhythmia - Supraventricular tachycardia. Patient complains of palpitations and heart racing. Chest pain and difficulty breathing.  10/13/09 ICD-9 Codes received: 427.89 Other specified cardiac dysrhythmia, 780.4 dizziness, 786.05 paroxysmal nocturnal dyspnea, 785.1 palpitations, 785.0 Tachycardia unspecified.
This spontaneous report was received from a medical assistant refers to three 17 year old patients of unknown gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On unspecified dates, the patients were vaccinated with an adult dose of VAQTA (lot number R000180 with expiration date: 21-MAR-2019) for prophylaxis; the strength and doses were not reported for the vaccines. No adverse effects reported.
Breakthrough case admission after 3 vaccines  Moderna 1/30/21 lot# 007M20A ; Moderna 2/27/21 lot# 038K20A;  Moderna 11/5/21 no lot #
Expectoration; Coughing; Fatigue; Lightheadedness; Lower back ache; Vaccination related malaise; Lethargy; Headache; Sensation of heaviness; Feeling abnormal; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling abnormal), BACK PAIN (Lower back ache), VACCINATION COMPLICATION (Vaccination related malaise), LETHARGY (Lethargy) and DIZZINESS (Lightheadedness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included ADHD.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced FEELING ABNORMAL (Feeling abnormal) and DISCOMFORT (Sensation of heaviness). On 28-Mar-2021, the patient experienced BACK PAIN (Lower back ache), VACCINATION COMPLICATION (Vaccination related malaise), LETHARGY (Lethargy) and HEADACHE (Headache). On 29-Mar-2021, the patient experienced DIZZINESS (Lightheadedness). On 30-Mar-2021, the patient experienced PRODUCTIVE COUGH (Expectoration), COUGH (Coughing) and FATIGUE (Fatigue). At the time of the report, FEELING ABNORMAL (Feeling abnormal), BACK PAIN (Lower back ache), VACCINATION COMPLICATION (Vaccination related malaise), LETHARGY (Lethargy), DIZZINESS (Lightheadedness), PRODUCTIVE COUGH (Expectoration), COUGH (Coughing), DISCOMFORT (Sensation of heaviness), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Non significant follow up received on 12-MAY-2021, no new information
30 min post vax began to cry excessively-cried continuously until taken to ER approx 8PM-Given tylenol @ home mom noticed redness & swelling around inject site approx 2 hrs p/inject given. No elevated temp.
patient was unknowingly given the wrong vaccine she was given 0.3 mls of undiluted pfizer bilvalent age 5-11 and should have received pfizer bivalent age 12 +
Patient reported a red raised rash around the injection site that was warm to the tough and about as big as a softball. only lasted a few days less, than a week.  Patient did not specify what he did/ took for rash.
Expired vaccine administered to the patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to the patient) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to the patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to the patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was initially stored in the refrigerator on 04-Apr-2022. The vial did not undergo any temperature excursions. It was reported that pharmacist thought that the vaccine expired in Jun-2022, however it was expired on 01-Apr-2022.  No treatment information was reported.
Runny nose, followed by light coughing, followed by nasal congestion and discharge and heavier coughing. WILL REQUIRE A DOCTOR VISIT.
Fever, CoughWheeze, Syncope, weakness, sore muscles Narrative: Out of work, due to the symptoms of weakness, sore muscles and no energy.
pain at the injection site for 1.5 days; tired; really sore arm; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient stated that she received the first dose of the Pfizer BioNTech COVID-19 vaccine 19 days ago. She explained she had pain at the injection site for 1.5 days following the vaccine. She added yesterday she had a really sore arm that has been bothering her and she was tired. She specified she then slept for 1 hour and felt fine. Patient would like to know if these are normal symptoms to the vaccine and asked if people have reported those symptoms after the vaccine, if she can get the second dose in the same arm. Patient would also like to know if her report help benefit other people receiving the vaccine. Outcome of the events was recovered.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.