chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was fine for several minutes, and at the end of the 15 minute observation time, he reported feeling funny and he looked very red but was breathing well.  He then reported tingling all over chest and arms, and left lateral chest pain.   He was taken to lie down,  VS were HR 80 PB 185/100, with continuing chest pain.   He accept offer for ambulance transport and they were called.    Other Public Health Nurses were put on alert.  Mask removed to improved oxygenation.   911 operator asked about medication, allergies, history of bleeding.  Patient denied any bleeding or allergies to ASA and was given 325 mg ASA at 2:50 when some was located.   BP improved to 165/85 and HR 76 with decrease in redness and symptoms.BP improved to 165/85 and HR 76 with decrease in redness and symptoms of discomfort decreased.   First responders (fire department) arrived, further questioning showed patient was giving slightly inconsistent history answers.   Paramedic and ambulance arrived for transport.   Patient taken to a local Hospital Emergency Department.     (as of 5/6/2022 3:50 pm per RN) Patient was observed on telemetry for 7 hours.   Diagnosis: non-STEMI and tobacco abuse disorder.   Discharged to home/self-care 5/9/22 22:00 pm  (as of 5/11/22 1 pm per RN)
febrile sz-like activity;temp 105 @ hosp;PE performed-WNL;lab WNL;pt monitored & antipyretic given;t102.3 p/med;no other activity noted;pt d/c to home on antipyretic tx;
Patient was given Menactra instead of MMR.  Vaccine is licensed to give 9 months to 55 years.  Contacted the LHD and was told there may be swelling at the injection site.  Recommended to ice the site.  Chief Medical Officer called and spoke with Mother.  Mother will follow up in the near future to receive the MMR vaccine.
I had a swollen red lump on my arm for about two weeks after the vaccine. I started having symptoms on 09/12/2022 with a scratchy throat and sinus issues. I tested positive with a home test for COVID-19 on 09/13/2022. I called my doctor on 09/14 and was prescribed antibiotics. I started feeling better within a week or two. As of today, I continue to have a cough and brain fog.
fever, rash, edema;Ibuprofen & APAP intermittently;
on XX/XX/2022, the incorrect patient was called back. MA stated that they verified patient's first name. Patient had visit with provider. Patient was expecting to receive Testosterone injection, but instead received Flu vaccine to left deltoid. Called patient to inform of incorrect medication administration, with no answer. Patient was left 3 voicemails to return call regarding appointment on XX-XX-22. Fluzone Quad Lot # UJ8788AA Exp: 06/30/2023 NDC: 4928-637-78
The patient was administered Pneumovax 23 08/21/23. After 10 minutes, the patient noted dizziness, weakness, and a choking feeling. The patient received Benadryl and O2. MD and charge nurse were at the patient's bedside, and EMS was called. The patient's symptoms improved, and the patient declined to go to EMS to ED for further evaluation.
Dizziness; Weakness; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6206) via an unspecified route of administration in the left arm on 11Mar2021 at 09:15 (at the age of 75-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unknown concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Mar2021 at 07:00, the patient experienced dizziness and weakness. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events dizziness and weakness were recovered with sequelae on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
PATIENT STATES THAT AROUND BEDTIME (10/26/12) SHE BEGAN SUFFERING FROM TERRIBLE CHILLS. SHE STATES THE CHILLS LASTED THROUGHOUT THE NIGHT. IN THE MORNING HER TEMPERATURE WAS ~99 DEGREES. UPON FOLLOW UP HER TEMPERATURE IS APPROX 100 DEGREES AT 3:45PM (10/27/12). THE PATIENT ALSO STATES THAT SHE HAS HAD A COUGH SINCE THE VACCINE.
Noted spots but all kids had mosquito bites- but patient had red spots with scabs - 07/19/2005.  Red like a zit on face when picked up from sitter at 3PM.  This AM 100 little dots over chest.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 09-NOV-2015, the patient was vaccinated with a dose of improperly stored PROQUAD lot # L011080, expiry date 01-OCT-2016, (dose, strength, route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Case symptom onset was 7/31/2021. Symptoms included muscle aches, runny nose, sore throat, loss of taste and smell, headache, fatigue, cough, abdominal pain and diarrhea. Case was still symptomatic upon Case Investigation completed on 8/4/21.
Initial report received on 05 November 2009 from a healthcare professional. An 8 year old female patient, with no medical history, received a right deltoid intramuscular injection of H1N1 (lot number UP004AA) and a left deltoid intramuscular injection of FLUZONE (lot number U3210AA) on 16 October 2009. The patient had no concomitant medications and no illness at the time of vaccination. She has received no other vaccinations within the previous four weeks and she had no adverse event following prior vaccinations. On 23 October 2009, one week post vaccination, the patient experienced severe muscle cramps in both arms. The pain spread across the chest in the biceps area. At the time of the report, the symptoms were reported to have worsened over the previous few days. The patient was seen by a physician on 04 November 2009. Corrective treatment was NAPROSYN 250 mg. At the time of the report, the patient had not recovered. Follow-up information received on 07 December 2009 from a health care professional. The H1N1 and FLUZONE vaccines were the first doses the patient had received on 16 October 2009. No other vaccinations were received within four weeks of that date. Diagnostic tests included a CBC (complete blood count) test that was normal; however the date the test was competed was not reported. At the time of this report, the patient had recovered. No further information is expected. Documents held by sender: None.
pregnant at time of vaccination O40.3XX0 - Polyhydramnios, third trimester, not applicable or unspecified
On 9/7/07, fussy, no bottle, fever, blister on tongue. Wouldn't eat. More blisters developing in mouth. Sept 12, saw doctor, 102 F AX. Doctor prescribed  anti-viral (Cesprazil). No improvement. Blisters on chin and neck. Back to doctor. Dx- Chicken pox, 'from the inside out." Temp 103 F AX. No chicken pox exposure before vaccine. Anesthetic given for mouth. Motrin/Tylenol switched every 2 hours. Presently 101 F AX at night - Normal temp during day. Eating ice cream and cold jello. Back to routine naps. Lesion beginning to scab and fall off. Child was exposed to Parvo from puppy 3 months ago and developed Parvo. Mother says doctor says immune system might have been weakened from Parvo.
Redness L thigh several days after immunizations. Redness gone still with small bumps 8/29/02. The follow up received on 9/9/02 states, report by phone only-not seen in office. No Rx-observe. To be checked at next visit.
I am currently trying 35 weeks pregnant (34 weeks 6 days at time of injection). No complications with pregnancy from vaccine side effects known at this time. Due June 2, 2021. Experienced extreme fatigue and brain fog the day after the 2nd dose and moderate injection site pain. Temperature was elevated slightly to 99 degrees so I took a dose of Tylenol. Symptoms are mostly resolved 24 hours after appearing.
herpes simplex on the lower lips; redness; fatigue; muscle pain; lesions; This non-serious case was reported by a physician via call center representative and described the occurrence of herpes simplex labialis in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 01-SEP-2023, the patient received the 1st dose of Shingrix. On 03-SEP-2023, 2 days after receiving Shingrix, the patient experienced herpes simplex labialis (Verbatim: herpes simplex on the lower lips), erythema (Verbatim: redness), fatigue (Verbatim: fatigue), muscle pain (Verbatim: muscle pain) and skin lesion (Verbatim: lesions).  The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the herpes simplex labialis, erythema, fatigue, muscle pain and skin lesion were not resolved.   It was unknown if the reporter considered the herpes simplex labialis, erythema, fatigue, muscle pain and skin lesion to be related to Shingrix.     It was unknown if the company considered the herpes simplex labialis, erythema, fatigue, muscle pain and skin lesion to be related to Shingrix.   Additional Information: GSK receipt date: 07-SEP-2023 The physician was the patient himself had his first dose of Shingrix and after 3 days he developed herpes simplex on the lower lips, he developed more lesions and had to start Valtrex.  He waited 4 to 5 days and lesions are getting worse . He also had systemic symptoms like muscle pain, fatigue and redness. The reporter consented to follow up.
This spontaneous case was reported by a consumer and describes the occurrence of EATING DISORDER (Cannot eat or drink anything) and VOMITING (Throwing up twice) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EATING DISORDER (Cannot eat or drink anything) and VOMITING (Throwing up twice). At the time of the report, EATING DISORDER (Cannot eat or drink anything) and VOMITING (Throwing up twice) outcome was unknown. No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events were not applicable.
This is a spontaneous report from a contactable nurse. A male child patient (age unknown) received a dose of PREVNAR13 on 29FEB2012. Relevant medical history and concomitant medications were unknown. Since 29FEB2012 the patient experienced reflux which has worsened over time, had poor appetite and was irritable. Relevant laboratory tests of the patient were unknown. The therapeutic measures taken at the time of report were unknown. The clinical outcome of the event was unknown at the time of report. Follow-up (29APR2012) Follow-up attempts completed. No further information expected.
UTI; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (UTI) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concomitant products included METOPROLOL and APIXABAN (ELIQUIS) for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced URINARY TRACT INFECTION (UTI). The patient was treated with CLARITHROMYCIN (MACROBID [CLARITHROMYCIN]) for Adverse event, at an unspecified dose and frequency. On 08-Mar-2021, URINARY TRACT INFECTION (UTI) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
In October 2022, my blood pressure was high, 142/92, I was put on a monitor.  In April 2023, it was 152/96 and in May of 2023 it was 170/90.  I've been given a water pill to help and I have changed my diet and it has helped.  There are no symptoms.  The only way I know is when I check my pressure.
Pt developed headache with vision loss on the right eye which has since resolved. She had vomiting and bloody nose as well.
This spontaneous report as received from a medical assistant refers to 4 years child patient of unknown gender. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX was exposed to 46F for 1 hour, at worst. The patient received VARIVAX dose 0.5 ml, intramuscularly, lot J006358 expiry 23-MAY-2015, between 12-APR-2014 and 24-APR-2014. There was a site visit from local health department on a unspecified date. No adverse effect was reported. This is one of several reports form the same source. Additional information has been requested.
Small amt of bruising surrounded by area of erythema near injection site.  Area slightly warmer than surrounding skin.
Has a cold; cough; congested; runny nose; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Has a cold), COUGH (cough), NASAL CONGESTION (congested) and RHINORRHOEA (runny nose) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced NASOPHARYNGITIS (Has a cold), COUGH (cough), NASAL CONGESTION (congested) and RHINORRHOEA (runny nose). On 28-Mar-2021, NASOPHARYNGITIS (Has a cold), COUGH (cough) and NASAL CONGESTION (congested) had resolved. At the time of the report, RHINORRHOEA (runny nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
12 hours after vaccine I had the same reaction as the 1st dose. I had fever and that fever included night sweats, body aches, headache, stomach pain, tiredness, and loss of appetite. Symptoms lasted for 3 days.
I have developed persistent tinnitus, of a frequency over 8000Hz, and it is 24/7. I visited my doctor today to ask for a hearing test and I've been referred to Head and Neck Dept. I find myself having to use earbuds to listen to white noise during the day to try to drown out the ringing. I have no medication changes, no head injury, no loud noises. I am retired.
With in 3 hours of shot pt reported throat swelling and uvula swelling with one side thicker than the other. She also reported flu-like symptoms w/ malaise, achyness. She took Benadryl and that relieved her throat symptoms.
patient came to pharmacy on 10/22/22 to receive a pneumonia vaccine.  Instead she received Fluad..  Patient stated on 10/29/22 when she came pharmacy again that she did not receive the correction vaccine on 10/22/22.  She had already received Flucelvax on 9/10/22.  She said she felt sick the next 2 days after the Fluad vaccine.  She did receive the Prevnar 20 on 10/29/22.
expired dose of Ipol was inadvertently administered; Initial information received on 30-Jul-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an 11 years old female patient who inadvertently received an expired dose of vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) for Immunisation; and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for Immunisation.  On 30-Jul-2019, the patient received a single 0.5 ml fourth dose of suspect IPV (VERO) lot N1G411M (expiry date: 28-Jul-2019) via intramuscular route in the right deltoid.  It was a case of actual medication error due to expired vaccine used.  It was not reported if any adverse event was experienced.  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 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.  Documents held by sender: none.
Patient same day experienced erythema, pain and swelling to the left arm with persistent erythema to the medial aspect of the arm and mild swelling to the deltoid 2 days later.
Information has been received from a physician concerning a female who on 25-MAY-2007 was vaccinated with a single dose of Zostavax (Oka/Merck).  It was reported that on 25-MAY-2007 the patient developed redness on her arm and hardness at the injection site. On 27-MAY-2007 the patient recovered.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information has been requested.
Flu; Initial information received on 21-Oct-2021 regarding an unsolicited valid non-serious case from a Social Media via a consumer/non-health care professional.  This case is linked to case 2021SA356566 (same reporter).  This case involves a patient (unknown demographics) who had flu (influenza) after receiving INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  It was unknown if the patient had any concomitant disease or risk factor.  The patient's medical history included mild corona virus disease of 2019 (COVID-19).  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (batch number and expiry not reported, formulation: suspension for injection) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  It was reported "Got a few shot couple years, as well as my partner, we both got the flu anyway, was way worse than the mild Covid we had this year."  It was unknown if the patient experienced any additional symptoms/events.   It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, outcome of the event was unknown.  The reporter did not report the causality of event with suspect.  There will be no information available on the batch number for this case.
Client given immunizations 05/02/05, Sx of swollen glands in neck and discomfort swallowing started on 05/09/52005 I saw her throat day after Dx her with an URI and CA cols. I alsos gave her meds foe the seasonal allergies.
A patient received Gardasil 9 about 2 years ago; The patient is wanting to finish the series; This spontaneous report has been received from a pharmacist referring to a 37 year old male patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.    On an unspecified date in 2018 (reported as "about 2 years ago"), the patient was vaccinated with the first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) dose 1 (strength, dose, route, frequency, anatomical location, lot # and expiration date were not provided) for prophylaxis. It was reported that the patient want to administer the third dose (inappropriate schedule of product administration and circumstance or information capable of leading to medication error).
Patient said her arm turned red, became swollen, and warm to the touch. It was also extremely sore. It began the night the vaccine was given. She reported it to her doctor 3 days later that she still had symptoms.
Shingles in left thigh radiating to left lower abdomen two days after vaccine Went to Urgent care 2 days after pain/rash started Treated with Acyclovir for 1 week 10 days later, rash improved. Pain continues, somewhat improved.
Patient had an allergic reaction/rash in the upper body: arms, face, shoulders, chest and back. Red rash appeared 3 days after the vaccine. Patient reported the rash with a burning sensation. Itching and swelling of the skin with hives
Chest pain Trouble breathing  Fever Rash on arm around the place the shot was given  Itching on hands and feet  Swollen fingers  Swollen tongue  Swollen feet Swollen throat  Dizziness  Nausea Headache Diarrhea  Stomach pain
Vomited up dose 3 of Vivotif within 30 minutes; Resumed taking dose 3 on day 6 and dose 4 on day 8; A spontaneous report was received from a nurse on 28NOV2022. It described a child (unknown age and gender) who "vomited up dose 3 of Vivotif within 30 minutes" (PT: Vomiting) and "resumed taking dose 3 on day 6 and dose 4 on day 8" (PT: Inappropriate schedule of product administration). The patient took oral Vivotif (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation. It was reported that the patient took the first three doses of Vivotif as scheduled on day 1, 3 and 5, however vomited up the third dose within 30 minutes due to norovirus. Reportedly, the third dose which was intact; was recovered by the patient's mother and was refrigerated. Furthermore, it was reported that the patient resumed taking the third dose on day 6 with no problems and the fourth dose on day 8. The patient had recovered from the event "vomited up dose 3 of Vivotif within 30 minutes" at the time of this report, whereas the outcome of the event "resumed taking dose 3 on day 6 and dose 4 on day 8" was not applicable.  Action taken with Vivotif with respect to the reported events was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer vomited up dose 3 of Vivotif within 30 minutes (vomiting) and resumed taking dose 3 on day 6 and dose 4 on day 8 (inappropriate schedule of product administration). Further information regarding the events is limited. Considering the case information, the role of Vivotif cannot be ruled out and the causality of vomiting is assessed as possible. Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer vomited up dose 3 of Vivotif within 30 minutes (vomiting) and resumed taking dose 3 on day 6 and dose 4 on day 8 (inappropriate schedule of product administration). Further information regarding the events is limited. Considering the case information, the role of Vivotif cannot be ruled out and the causality of vomiting is assessed as possible. Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif. The case is considered non serious as per medical assessment.
L JUGULAR AND UE DVT LEFT UPPER EXTREMITY SWELLING ACUTE THROMBOSIS OF LEFT BRACHIAL VEIN ACUTE THROMBOSISOF LEFT BASILIC VEIN ACUTE THROMBOSIS OF LEFT INTERNAL JUGULAR VEIN
Sudden onset of weakness (back and neck)progressed to lower extremities described as "gel legs", difficulty standing  DX with Guillain-Barre Syndrome