chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had heart palpitations after their booster shot; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (had heart palpitations after their booster shot) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Limited. Initials & DOB unknown.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (had heart palpitations after their booster shot). At the time of the report, PALPITATIONS (had heart palpitations after their booster shot) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   The reporter's mother worked with Drs and one of them said they had heart palpitations after their booster shot, too.  No concomitant or treatment medications were reported.   Reporter did not allow further contact
Patient received vaccine on 8/4. On 8/5 patient started getting shoulder pain and fever greater than or equal to 101 degrees F, redness swelling of arm. Went to MD and was concerned patients arm was infected. Received cefadroxil 500 mg antibiotic.
patient received expired vaccine PENTACEL/no AE; Initial information regarding an unsolicited valid non-serious case was received from the other health professional, non-healthcare professional, physician via Medical Information (Reference number- 00778696) and transmitted to Sanofi on 21-SEP-2021.  This case involves a 4 months old male patient who received expired vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (expired product administered).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for prophylactic vaccination.  On 19-Jul-2021, the patient received a 2 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number: UJ214AAA and expiry date: 02-MAY-2021) via an intramuscular route at an unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (on the same day).  It was reported "Caller reports the patient received expired PENTACEL, the new office does not offer PENTACEL they offer Pediarix, the patient is coming in for the 6 month shots, so they need to know how to make sure the child will receive a complete series; is there any leeway with the expiration date of PENTACEL, if the expired dose is not valid how do they catch the patient up with the Pediarix vaccine instead of PENTACEL."  At the time of report, the outcome was unknown for the event.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
VERY SORE ARM AND ACHINESS IN LEGS WITH SHARP PAINS; This spontaneous report received from a patient concerned a 48 year old male. The patient's weight was 175 pounds, and height was 68 inches. The patient's pre-existing medical conditions included: The patient had no known allergies and no medical history. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1821286, expiry: 21-OCT-2021) dose was not reported, administered on 01-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-SEP-2021, the patient experienced very sore arm and achiness in legs with sharp pains. The action taken with covid-19 vaccine was not applicable. The patient recovered from very sore arm and achiness in legs with sharp pains on SEP-2021. This report was non-serious. This case, from the same reporter is linked to 20210909059.
Initial report received from a consumer, who is also the patient's parent, on 08 November 2012 with follow-up information received from the patient's physician's office. The event was reported during the course of a vaccine brand usage survey being conducted by a national sampling organization on behalf of sanofi pasteur. A female child (age not reported) had received three doses of PENTACEL; lot number C3162BA received in June 2009, lot number C3224AA received in April 2009 and lot number C3228AA received in February 2009, and one dose of DAPTACEL, lot number C3358AA in July 2010. According to the patient's parent, on an unspecified date, the patient developed whooping cough and their physician stated that the episode of whooping cough could have been worse if she hadn't been vaccinated. Outcome was not reported. Additional information received from the patient's physician noted that the physician's facility had no record of pertussis diagnosis. No additional information was provided at the time of the report. Documents held by sender: None.
Information has been received from a physician concerning a 9 yr old pt who in 1997 was vaccinated with a dose of varicella virus vaccine live. Subsequently the pt experienced breakthrough chickenpox with less than 50 lesions and no fever. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Three hours after injection, developed headache, throat sore, no fever, no sweats, no rash, no cough, no diarrhea, no redness. Joints, knees, fingers, elbow aching. Symptoms x 5 days
I felt like had a flu, fever, stomach pains, lack of appetite, extreme fatigue, felt like I never got enough sleep, 2 weeks after I got a kidney infection. I went the doctor they said my white blood cells went up, they have me antibodies and I also got side pains and I had night sweats. Gave me medications still having problems and fatigue and no energy.
A nurse reported that a pt received an injection of flu shield and subsequently developed induration at the injection site. The pt recovered. This is 1 of 4 pts from this facility who had an adverse experience following receipt of flu shield. The reporter indicated that lot 4018032 had expired June, 2001; however, Product Quality has indicated that this is a valid flu shield lot number.
This spontaneous report was received from a pharmacist via a company representative, regarding a to a male patient of unknown age (over the age of 65). The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 intramuscularly, which had a lot # N022303 with an expiry date on 01-MAR-2018, (dose, frequency, anatomical location of administration were not provided) for prophylaxis. On an unspecified date after vaccination the patient experienced "had an allergic reaction". He received BENADRYL as a treatment and fully recovered in about a day. The causal relationship between vaccination with PNEUMOVAX 23 and the event was not mentioned. This is one of two reports received from the same source. Sender's Comments: US-009507513-1710USA008403.
About 12 days following the vaccine, I broke out in hives all over my body. I started to swell, especially in head and face area. Had slight trouble breathing for first 3-4 days. The hives have subsided but are still very present - 4 months after the first breakout. Sometimes I swell, but it's not frequent. Instantly breakout in hives upon contact with skin.
Td vaccine administered 8/22/03 around 4pm. Vaccine was given in L deltoid. Child was fine until 3:15am that night when he woke up and had a terrible headache, his eyes were sensitive to the light and he complained of body aches. His temp was 100 deg F and he had 2 episodes of vomiting. Symptoms lasted 48 hrs and child was not seen by a physician.
Extensive IVC and renal vein thrombus, multiple PEs, hospitalized for 5 days. Experienced syncopal episode due to decreased preload secondary to thrombus. Emergent evaluation in the ED. CTs revealed extensive clotting and PE. Required emergent cath procedure now on lifelong anti coagulation. Plan for further evaluation and additional cath procedures.
Left arm red swollen warm. Shot given 9-15-16. Pt went to urgent care 9/17/16. Had been using Clindamycin and BENADRYL.
A mother reported that her 3 year old son received his 1st dose of Prevnar on 7/11/01 and developed an injection site reaction characterized by redness and swelling. These symptoms resolved. Her son subsequently, developed "facial swelling or angioedema" which persisted at the date of the report. This event was considered "Medically Important". No further information was available at the date of the report.
This spontaneous report as received from a male consumer of unknown age. On 24-MAR-2013 (reported as a year ago) the patient was vaccinated with PNEUMOVAX 23 (Lot # not reported) (dose, route and frequency not reported). No other co suspects were reported. Concomitant therapies included PREVNAR 13. On an unknown date the patient experienced a green/yellow nasal discharge and bloody discharge from his nose. The outcome of he has green/yellow nasal discharge and bloody discharge from his nose was unknown. Additional information has been requested.
7 weeks at vaccination due date 11/14/2021 was due third pregnancy had successful pregnancy, Normal pregnancy and next two days was very sick, body aches, fatigue, Tues. Tuesday 03-30-2021 she experienced bleeding and at that time was 7 weeks 2 days pregnant ER went to the doctor and they indicated that she would need to return, then on Thursday 04-01-2021 she had a miscarriage and it was confirmed that she was having a miscarriage.
Information has been received from a pharmacist via field representative referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (route, lot# and dose were unknown). On an unknown date the patient experienced an unspecified adverse reaction. The outcome of adverse reaction was reported as recovered/resolved. The relationship of the adverse reaction and PNEUMOVAX 23 was not reported. Additional information has been requested.
I have been experiencing Vertigo, Balance issues, nausea since  April 5th, more than 10 days after the first dose of Pfizer vaccine. I have been to primary care and neurologists, no concrete answer on cause or treatment. This vaccine is the only different thing I did since I work from home during weekdays.  Nausea has tapered off but balances issues still prevalent and difficulty in walking in a straight line and driving. Vertigo medicines are of no help either
2 days later 28MAY98 630AM grand mal sz-requiring EMT & transported by amb to hosp-full resuscitation recovered-lethargic-transferred to another hosp;
Headache, Tachycardia, chills, fever, body aches Narrative:  took Excedrin for headache
On approximately 3/2 or 3/3 (patient was unsure due to losing consciousness) patient was found by friend unconscious in her apartment with a fever reported to be 105 degrees F.  Patient was taken to hospital and released to nursing home care.
p/vax lab tests revealed negative titers for varicella antibodies;The reporting MD felt that lack of response was not r/t vax;
After dose 1, patient had mild episodes of lightheadedness/dizziness that resolved spontaneously. Occurred while she was sitting at home. After dose 2, patient had episode of lightheadedness/dizziness that occurred while she was walking in grocery store. Did not have palpitations. She syncopized. Subsequently, has been asymptomatic. Not having dyspnea or chest pain.
Breasts became extremely swollen and tender  Obvious clear vaginal discharge Occurred very soon after vaccination and remained for two approximately two weeks
Fever, dizziness, vomiting, nauseous, chills, L arm tingling to finger tips, headache
Information has been received from an office manager concerning a 5 year old male with pre-existing allergies, birth defects, medical conditions that included: "NKDA", (previously reported as no pertinent medical history and no allergies), who on 22-AUG-2003 was vaccinated SC with a first and only 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (lot number: 645291//0201N). Concomitant therapy included measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) in the right arm. On 16-JAN-2008, the patient was seen in the office with a varicella outbreak, pharyngitis, an ear infection in both ears and a low fever. Treatment was antibiotic, Aveeno soap and lotion. The patient had a follow-up visit with the doctor the next day. No other information. There were no lab diagnostic studies performed. Unspecified medical attention was sought in the office. The outcome was reported as not recovered. There was no product quality complaint. Follow-up information indicated that on 16-JAN-2008, the patient was diagnosed with varicella, fever. The outcome was reported as recovered. No additional information is expected.
Redness and swelling of left thigh after immunization. Dx: cellulitis. TX: BACTRIM by mouth 10 days.
had problems for one night and one day; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (had problems for one night and one day) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE DRUG REACTION (had problems for one night and one day). At the time of the report, ADVERSE DRUG REACTION (had problems for one night and one day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   No concomitant medication information was  provided.  It was reported that unspecified moderna product manufacturer, not provided Investigation assessment. And also stated that her roommate took the moderna one and only had problems for one night and one day. Patient missed one day of work.   Patient thought that he was going to die and did not work the next day. Patient was not allergic and he did not have to worry about it.   Patient  doesn't have sympathy. Men can be single handedly stubborn. Patient had a sprained thumb right now. It was 3 weeks later and he was walking around with ice on it. He said that icing made it feel better.  No treatment medication information was provided
My arm has been swollen for over 4 days and is very itchy and red. It has been very painful to the touch
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related injuries. On or about 2013, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 2015, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
This spontaneous report was received from a nurse regarding multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were unknown. On unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL 9 (lot # M024261, expiration date 30-JUL-2018) (dose and route unknown) for prophylaxis. Concomitant therapies included sterile diluent (manufacturer unknown). The nurse confirmed that sterile diluent (manufacturer unknown) was properly stored. No adverse effects were reported. The temperature excursion was between 47 degrees Fahrenheit (F) to 77.4 degrees F (66.4 degrees F) for a time frame of 3 hours and 22 minutes. There was no previous temperature excursion. This report was because of data logger. This is one of several reports from the same reporter (1708USA002328, 1708USA002362 and 1708USA002363). Sender's Comments: US-009507513-1708USA002362: US-009507513-1708USA002363: US-009507513-1708USA002328.
Acute Deep Vein Thrombosis of the Right Subclavian Vein; Swelling of his right arm; This is a spontaneous report received from a contactable Physician. A 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via intramuscular, administered in right arm on 14Feb2021 (Lot Number: el9269) at single dose for COVID-19 immunization in workplace clinic. Medical history included hypertension, hyperlipidemia, lyme, osteoarthritis. There was no known allergies. Concomitant medications included lisinopril; pravastatin; pantoprazole sodium sesquihydrate (PROTONIX). It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of bnt162b2 via intramuscular, administered in left arm on 24Jan2021 (Lot Number: en5318) at single dose for COVID-19 immunization. The patient evaluated in the emergency room on 18Mar2021 for swelling of his right arm.  Patient had a venous doppler right ext, which showed acute deep vein thrombosis of the right subclavian vein. The events result in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care, and serious for life threatening illness. Treatment for the events included rivaroxaban (XARELTO) and referral to hematologist. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not resolved.; Sender's Comments: Based on the information currently available, causality between reported events Subclavian vein thrombosis and Peripheral swelling and BNT162B2 vaccine cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
pt recv vax 26APR96 parents reported 3-4hrs non-stop crying (100 temp or higher?) to clinic @ time of 2nd series;mom unsure what the temp was;states APAP given & dec the crying;
Patient stated after she was given the flu shot on Saturday she suffered from insomnia and sneezing. Sunday morning she had a rash on her chest. She reported the incident on Tuesday and stated it was going away.
NAUSEA; SEVERE HEADACHES; VOMITTING; HURTING ALL OVER; This spontaneous report received from a consumer concerned a 25 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, and expiry: 04-JUL-2021) dose was not reported, administered on 08-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-JUN-2021, the subject experienced vomitting. On 08-JUN-2021, the subject experienced hurting all over. On 08-JUN-2021, the subject experienced nausea. On 08-JUN-2021, the subject experienced severe headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, vomitting, hurting all over, and severe headaches. This report was non-serious. This case, from the same reporter is linked to 20210619423 and 20210619315.
Pharmacist reports that after administration of 1st dose of Moderna 08/12/2021, Pt. started to experience tingling and slight swelling in the right leg. Still continuing as Pt. left the facility.
covid-19; covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 70-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: No other medication in 2weeks. Patient received paxlovid as COVID-19 treatment from 22Sep2022 via oral route.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201191142 Same reporter/patient, different product/events;
Pt developed erythema, edema and induration at the vaccine site this was followed by vesiculation.
This case was reported by a healthcare professional and described the occurrence of bad taste mouth in a 40-year-old female subject who was vaccinated with Engerix-B (GlaxoSmithKline) for prophylaxis.  On 17 November 2006 at 3:15 p.m., the subject received 3rd dose of Engerix-B in the left deltoid.  On 17 November 2006 at 3:15 p.m., immediately after vaccination with Engerix-B, the subject experienced bad taste in her mouth.  The reporter stated that the subject, "did not experience this reaction with her previous (two) doses."  On 17 November 2006, the subject also received 2nd dose of Havrix (GlaxoSmithKline).  The exact time of administration of Havrix was not reported.  The outcome of the event was not reported.
Temperature 103 F Redness, Swelling, Arm Pain Tylenol Given Primary Care Physician seen 05/08/2011 IV Rocephin 05/08/11 13:36