chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 10-JUN-2013, a healthcare provider at an outpatient clinic administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2015, the patient was treated by a healthcare provider at an outpatient clinic for shingles. The patient was diagnosed with shingles and or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, 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 (not further specified); 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.
PATIENT REPORTED LIGHT HEADEDNESS, BLURRY PERIPHERAL VISION, AND DIZZINESS.
Approx. 3 hours, post vax, pt developed body aches, pain and a temperature of 100.2F (orally). Examined by physician, 2 days later, and instructed bed rest and Tylenol.
Reporter states 151 doses of Engerix-B was given; & c/o 5 people with h/a; 7 people dizzy; 1 person loss of appetite; 1 person stomachache; 6 people lethargy/fatigue/malaise; 4 people fever; 4 people muscle pain; 1-URT;
Today feels a little tired but they just had a hurricane and it is gloomy outside.; feels like a million dollars, feels amazing; Diarrhea; Vomiting; Flu-like symptoms; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0185 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 18Aug2021 at 11:00 AM (age at vaccination: 63 years), as dose 2, single dose for COVID-19 immunization at pharmacy. The patient's medical history included lyme disease (diagnosed years ago and she was deathly sick). Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0196 and expiry date was not reported), via an unspecified route of administration, on 28Jul2021 at 13:00 (age at vaccination: 62 years), as dose 1, single dose for COVID-19 immunization at pharmacy. Vaccine was not administered at Military Facility. The patient did not receive any vaccine prior vaccinations (within 4 weeks). The patient did not have family medical history relevant to adverse events. She had to say she felt like a million dollars on 21Aug2021 and has not felt this good in so many years, she started to feel this was about 3 or 4 days after the second dose. She was sick for a day and half, she had a little bit for vomiting, diarrhea, flu-like symptoms after the second dose on 19Aug2021. The diarrhea and flu-like symptoms recovered the next day. She took Advil as treatment. She was supposed to go somewhere on Saturday and was not sure if she was able to. She was usually asleep at 7:30 or 8 pm and instead was up till 11pm, she started feeling amazing. Today feels a little tired but they just had a hurricane and it was gloomy outside on 23Aug2021. She was good. The adverse events did not require a visit to emergency room and physician office. Outcome of the event vomiting was recovered on 19Aug2021, diarrhea and flu-like symptoms was recovered on 20Aug2021, feels like a million dollars, feels amazing was not recovered and for today feels a little tired but they just had a hurricane and it is gloomy outside, it was unknown.  Follow-up attempts are completed. No further information is expected.
The morning after my second vaccine, I discovered multiple small lumps in my left armpit.  It was painful to apply roll on deodorant.  Symptoms lasted for 3 days.  Online research stated this as a known side effect and advised if it was an ongoing issue after 2 months to seek medical attention.
My daughter received her second dose of Moderna vaccine 2 weeks post being sick with Covid-19. She was fine right after the shot and then a day and a half later her cough came back really strongly. It sounds like she has fluid in her lungs. She has a runny and stuffy nose and is feeling awful.
On Friday, 2/25/21, Patient came to Covid-19 Vaccination Site for a Pfizer Covid-19 dose. Client stated during check-in process, he received a Covid-19 Janssen dose in February 2021 with no proof of vaccination. Lead RN elevated to Clinical Project Coordinators via text who inquired with County MD Dr. Dr. approved client to restart series and receive Pfizer Covid-19 vaccine dose one today and was documented as first dose appropriately on his vaccination card. Client was vaccinated with Covid-19 Pfizer vaccine (LOT #: FK9895) in his left arm at 11:30 AM. Client denied any allergies or medications and any reactions from first Covid-19 Janssen dose and was to be a 15 minute observation. Client was educated by RN on signs and symptoms of adverse reactions and when to go to the ED/call MD. Client was also encouraged to sign-up on v-safe. Client experienced no adverse reaction while waiting in Observation Area and left vaccination site with a steady gait at 12:00 PM.
G3P1, 38 yo with prenatal care. All serologies negative. No pregnancy complications. Normal ultrasounds. EDD 2/14/2024. Received monovalent Moderna vaccine and developed a blood clot in the leg two days later. Currently monitoring. Received the Covid vaccine beginning in 2020 and a booster every year since. This is my first known reaction to the vaccine since.
During a mass vaccination clinic, client was administered one dose of Janssen COVID19 vaccine IM.  Pt was under age 18 at time of vaccination, Janssen and our standing orders for Janssen vaccine state patients must be 18 or older to receive this vaccine.
Patient presented to pharmacy on 11/3/11 with softball sized raised red circle at injection site. Small blisters were present in middle of reaction. Site started itching the night following injection. Continues to itch, but not worsening husband received vaccine same day from same lot & did not experience A/E. RPH contacted prescriber pt. advised to take TYLENOL or ADVIL and BENADRYL & ice if needed. Also told to follow up with MD ASAP.
Wed 4/19/2023 Unclear guidance given to us on change with covid vaccine. Monovalent no longer allowed to be given. Bivalent no recommended. Gave child Bivalent dose for 6months-5yrs when supposed to given vaccine for 6+ yrs. Child 2 yrs old and given lower dose 6 months - 5 yrs. very poor guidance given to pediatric offices for new covid vaccine recommendations. As of 4/19/2023 when monovalent vaccine was no longer allowed to be given, the only Bivalent, per system. for the age group, 6m-5yrs was a pink cap/yellow label. This was give to child a as his second dose when in Fact was supposed to get vial-blue cap/gray label - 6 years+. There was NO guidance given to why this higher dose, not was it on system. Lower dose 6mon-5yr dose was given. Guidance as of today is still not clear,
MARKS ON ARMS; This spontaneous report received from a consumer concerned an 8 decade 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: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced marks on arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of marks on arms was not reported. This report was non-serious. This case, involving the same patient is linked to 20220362290.
Child was given DTaP at age 7yrs 8mos - should have received adult Td. CDC: DTAP counts and was not need to be repeated.
Left deltoid muscle got hard; Warm at injection site; Pain at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site induration in a 84-year-old female patient who received Herpes zoster (Shingrix) (batch number 5KF37, expiry date 14th April 2020) for prophylaxis.   On 7th August 2019, the patient received Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site induration, injection site warmth and injection site pain. On an unknown date, the outcome of the injection site induration, injection site warmth and injection site pain were recovered/resolved.   It was unknown if the reporter considered the injection site induration, injection site warmth and injection site pain to be related to Shingrix.  Additional details were provided as follows: The registered pharmacist reported that patient received the first dose of Shingrix on left deltoid. The patient left deltoid muscle got hard, large pach, warm, painful at injection site. It lasted several weeks until it subsided. The healthcare professional (HCP) would like to know if patient should receive 2nd dose after these reactions. The reporter was consented to follow up.
11/15/22. I received the flu shot on my unit, immediately after I felt numbness going down my right calf, then left, sharp pain on right hand then numbness in tongue 5-10 mins after. I was told by my director to call for help. They came and asked questions and assessed me, like chest pain. I had no chest pain until ended and started walking"
High blood pressure...180/140.  4 days Rapid heart rate 144 per min.  3 days  Pain in every area of previous injury.  Still ongoing Extremely fatigued.  Still ongoing Headaches. Still ongoing  I was advised by Dr to take Xanax to reduce heart rate and take norvasc  2x day for blood pressure and continue to monitor
Mother called 7/10/03 states child started with fever PM of 7/9/03. On 7/10/03 AM noticed red spots/bumps - possible rash. Advised increased fluids, Tylenol, Benadryl as prescribed if no resolution in 1-3 days return to office. 7/14/03 Spoke with Mom - no further problems.
Developed fever; body aches; This is a spontaneous report from a contactable Other Health Professional reporting for himself. A 34-years-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot Ek4231), intramuscular in left arm on 13Jan2021 at single dose for covid-19 immunisation. The patient had an ongoing exposure to SARS-CoV-2 since on 21Dec2020 the patient children developed Covid symptoms and tested positive then his wife developed symptoms as well. Concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EJ1685) intramuscular in the left arm on 21Dec2020 for COVID-19 immunisation. The patient developed fever and body aches on 13Jan2021 with outcome of recovered in Jan2021. No treatment was performed due to the events. The patient was not diagnosed positive to COVID-19 prior to vaccination. The patient was tested negative for COVID via nasal swab on 22Jan2021.
1 hour or so after shot, arm was swollen and hot and hurt to touch. (gave Benadryl and Advil)-Blood sugar numbers started to raise. Had very high number for 3 1/2 days; some as high as over 50. Continued with extra insulin-called hospital for advise
Information has been received from a health care facility concerning a 37 month old white male who on 20-APR-2004 at 14:@0 was vaccinated in the deltoid with a first dose of Varivax (lot # 647270/1103N). On 22-MAY-2006 at 14:00 the patient broke out in chickenpox. At the time of the report, the patient had not yet recovered. Additional information has been requested.
This spontaneous report as received from a male nurse of unknown age via a company representative refers to himself. Pertinent medical history and drug reaction/allergies were not reported. On an unknown date the patient was vaccinated with 1 shot of PNEUMOVAX 23 (dose, lot # and expiration date were not reported) subcutaneously. Concomitant drug was not reported. On an unknown date the patient experienced shooting pain that went down from the injection site to finger tips after the vaccination and sought unspecified medical attention. The patient's condition improved and the PNEUMOVAX 23 was not reintroduced. The causality was not reported. This is one of the several reports from the same reporter. Additional information has been requested.
Shortness of breath, diarrhea, decreased appetite and abd pain, "food doesnt taste good"
Initial report received from a nurse on 29 Sep 2010: On 31 Aug 2010, this patient was vaccinated with only the MenCWY liquid conjugate component of MENVEO (batch number not reported), (dose: 0.5 ml) intramuscularly without lyophilized component. No adverse events were noted following this medication error. Follow up report received from a nurse on 08 Oct 2010. Reporter stated that, medication was not mixed both vials so only part of the vaccine was given. The patient was revaccinated since then and was doing fine.
15sec p/vax pt seemed to faint back becoming arched, eyes turned up, gen muscle contractions x 10sec & then able to sit up w/help;pt said tummy hurt-face pale & was lethargic x 10mins;advised go to ER who stated fainting from being nervous
Patient complained of severe achy arm left and left shoulder for 5 days. Concerned regarding 3mm pink area with clear dried serous droplet at puncture site.  No signs of swelling, nodular area, redness.  Denies any pain today denies fever at any time.
pt recv vax 6NOV98 & 8hr p/vax rt deltoid red/swollen area 13mm x 13mm measures 33cm lt deltoid 31cm;also onset of swelling of nasal mucosa/tightness w/breathing onset 24hr p/vax;
Patient developed a red, raised rash about an inch down from the injection site. Patient describes rash as "red, hot, and hurts", denies any itching or difficulty breathing.  Reached out to PCP and discussed reaction, advised for ibuprofen and benadryl 2-3x for 2 days.
nerve paralysis; bell's palsy; slurred speech; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (nerve paralysis), CONDITION AGGRAVATED (bell's palsy) and DYSARTHRIA (slurred speech) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included Bell's palsy (11 years ago, asymptomatic).    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced FACIAL PARALYSIS (nerve paralysis), CONDITION AGGRAVATED (bell's palsy) and DYSARTHRIA (slurred speech). At the time of the report, FACIAL PARALYSIS (nerve paralysis), CONDITION AGGRAVATED (bell's palsy) and DYSARTHRIA (slurred speech) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not provided by the reporter. Treatment Prednisone 60mg daily for 1 week.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Seriousness criteria other medically significant (OMIC). From initial information received on 4/27/2006 from a literature report, it was reported that a 7 month old male patient, who as 5 months of age had received budging fontanelle and fever 1 day post immunization with third dose of diphtheria tetanus pertussis vaccine DTP 3, the manufacturer, route and site of administration were not reported. The same patient had bulging fontanelle and irritability at 3 months of age following first dose of diphtheria tetanus pertussis vaccine DTP 1, and a first dose of trivalent oral poliovirus vaccine IPV 1, and had a repeated such occurrence accompanied by fever at 5 months of age (after administration of diphtheria tetanus vaccine DT 1, and a second dose of trivalent oral poliovirus vaccine OPV 2. The patient did not require hospitalization and his physical exam was normal. No CBC or lumbar puncture for CSF was complete. The patient recovered one day after the onset of the adverse events. Reportedly there were no conditions or exposure EG steroids that could have explained the event of bulging fontanelle. Subsequent followup determined that the patient was normal neurologically and developmentally. Case 200600973 captures the patients events at 5 months of age.  The reporter of this event is the same as for cases 200600970 to 200600976, 200600979.
Itchy arm; Swollen arm; Red at site of injection; Pain and soreness in calf muscle like charlie horse; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Pain and soreness in calf muscle like charlie horse), PRURITUS (Itchy arm), PERIPHERAL SWELLING (Swollen arm) and VACCINATION SITE ERYTHEMA (Red at site of injection) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain and soreness in calf muscle like charlie horse). On 18-Mar-2021, the patient experienced PRURITUS (Itchy arm), PERIPHERAL SWELLING (Swollen arm) and VACCINATION SITE ERYTHEMA (Red at site of injection). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) in March 2021 at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain and soreness in calf muscle like charlie horse), PRURITUS (Itchy arm), PERIPHERAL SWELLING (Swollen arm) and VACCINATION SITE ERYTHEMA (Red at site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unspecified birth control pills.
Client presented to Covid Vaccination Site on 10/19/2022 to receive first dose of Pfizer Monovalent COVID vaccine Lot#FR2583 on left arm. At 1627 while sitting in the observation area, client notified nurse that he felt ?Pinches all over body.? Client was able to move to gravity chair without assistance. Nurse proceeded to take vital signs; BP:131/77mmHg, HR:65, RR:16, O2:98%. Client reported no know allergies, no medical conditions, and no medications currently taking. Client denies itchiness and shortness of breath. No rash observed on left arm by injection site. Client reported to lead nurse a history of anxiety. Client reported he ate lunch about an hour ago, did not specify what he ate for lunch. At approximately 1638 vital signs; BP: 129/72mmHg, HR: 66, RR:16, O2:99% retaken by nurse. Lead nurse offered to have EMS activated, client denied. Client reported, ?I feel fine.?  Client reported to lead nurse, that he did not want to get vaccinated but had to because a job opportunity came up and a COVID vaccine was required. Client rested for fifteen more minutes in gravity chair. At 1650 client reported, ?I feel good.? Client denies pinches over body. At approximately 1653 vital signs were taken by nurse; BP:128/70mmHG, HR:68, O2:99%. Lead nurse educated client on possible side effects after vaccine and when to seek medical care and to follow up with his primary care provider. Client verbalized understanding. Grandmother stated she was driving. At approximately 1657 client left the facility with a steady gait accompanied by grandmother.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium
serious itching in extremities; tongue starting to swell; upper palate starting to swell; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (serious itching in extremities), SWOLLEN TONGUE (tongue starting to swell) and MOUTH SWELLING (upper palate starting to swell) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2021, the patient experienced PRURITUS (serious itching in extremities), SWOLLEN TONGUE (tongue starting to swell) and MOUTH SWELLING (upper palate starting to swell). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. At the time of the report, PRURITUS (serious itching in extremities), SWOLLEN TONGUE (tongue starting to swell) and MOUTH SWELLING (upper palate starting to swell) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medications were provided by the reporter She spoke to doctor who advised her to take Benadryl first before resorting to EpiPen that she keeps for anaphylactic reaction to bee stings.
Devel Henoch Schonleen purpura 5 days p/MMR given;
Diagnosis?s with TTP on March 12. Passes away on March 19 2021
Pain in the outer arm where the shot was given; Pain under the arm of the arm/in the armpit area where the shot was administered; Fatigue; This is a spontaneous report received from a non-contactable patient. A 40-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via unspecified route of administration on right arm on 23Mar2021 at 10:30 (at the age of 40-year-old) as a single dose, for COVID-19 immunisation. Medical history and concomitant medication were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Prior to vaccination the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021, the patient experienced pain in the outer arm where the shot was given (pain in arm), pain under the arm of the arm/in the armpit area where the shot was administered (armpit pain) and fatigue. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events pain in arm, armpit pain and fatigue were unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.