chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu like symptoms; Diarrhea; Dehydrated; Throat closing; Anaphylactic reaction; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Prophylactic vaccination: Flu shot (reactions to Flu shot). Past adverse reactions to the above products included Adverse event with Flu shot. Concurrent medical conditions included Allergic reaction to excipient.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant) and OROPHARYNGEAL DISCOMFORT (Throat closing). On 26-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), DIARRHOEA (Diarrhea) and DEHYDRATION (Dehydrated). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Anaphylactic reaction, at an unspecified dose and frequency. On 25-Feb-2021, ANAPHYLACTIC REACTION (Anaphylactic reaction) and OROPHARYNGEAL DISCOMFORT (Throat closing) had resolved. On 28-Feb-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved. On 05-Mar-2021, DIARRHOEA (Diarrhea) and DEHYDRATION (Dehydrated) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported Throat was closing right away after vaccination. She took Benadryl and next day she was okay. When she was dehydrated and her physician gave her intravenous (IV) fluids. The patient was also given natural remedies. Her physician told her not to get the second shot.  79 Y/O F, with prior allergic reaction to excipients in flu shot, had a serious expected anaphylactic reaction, with oropharyngeal discomfort, influenza like illness, diarrhoea, and dehydration. Onset the same day as first dose mRNA-1273. Events resolved with diphenhydramine. No rechallenge. Reporter causality not provided. Causality possible from temporal association. Events consistent with known profile of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: A 79 Y/O F, with prior allergic reaction to excipients in flu shot, had a serious expected anaphylactic reaction, with oropharyngeal discomfort, influenza like illness, diarrhoea, and dehydration. Onset the same day as first dose mRNA-1273. Events resolved with diphenhydramine. No rechallenge. Reporter causality not provided. Causality possible from temporal association. Events consistent with known profile of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Merck Vaccine Representative called on behalf of physician to report a patient who received GARDASIL 9 over a year ago had syncope within seconds of receiving injection. Limited patient demographic information available. No further information provid; This spontaneous report was received from a physician via company representative referring to a female patient of unknown age. The patient's concomitant medications, pertinent medical history, concurrent condition, and drug reactions/allergies were not reported.  On an unknown date (reported as over a year ago), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose, administered intramuscularly (IM) for prophylaxis (strength, anatomical location, lot #, and expiry date were not provided). Within seconds of receiving injection, the patient had syncope. At the time of the report, the outcome of syncope was not provided. Action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not applicable.  The causal relationship between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the event of syncope was not provided. Upon internal review, the event of syncope was determined to be medically significant.
Post vaccine chills; fever; aches; This is a spontaneous report from a contactable consumer. An adult patient in 5th decade (in early 40's) of unspecified gender received the first dose of BNT162B2 (solution for injection, lot number/expiration date: not provided) via an unspecified route on an unspecified date as a single dose for COVID-19 immunization. The Patient medical history and concomitant medications were not reported. On an unspecified date, the patient had post vaccine chills, fever and aches. The outcome of events was unknown.   Information on the lot/batch number has been requested.
My left arm is locked in a paralyzed stage where I haven't been able to lift it no more than a few inches since the second week that I got the Pfizer shot three weeks ago. The left side of my shoulder and neck was stiff like I had a muscle spasm for about the whole second week. I informed Nurse at my doctor's visit on April 28th at .  She advised me to apply heat on the areas, move and rotate the areas and to continue to take Tylenol,  I still am not able to fully lift my left arm. I will not be getting the second shot on May 6th 2021.
Client came in to receive dose of Johnson and Johnson vaccine after receiveing his first dose of Moderna (lot #048C21A) at  4 days prior on Friday 7/16/2021. Client felt fine at clinic after immunization was given, was brought to staff's attention only through looking up his immunization record in  immunization registry as a double check. When discussed with client, client stated he knew he received his first dose of Moderna but wanted to receive Johnson and Johnon in order to be fully vaccinated faster so he could travel to  when the borders opened to fully immunized people.
Extreme difficulty in rising from bed. Three hours later still very unsteady. By mid morning the unsteadiness was mostly gone. By evening all signs of discomfort were gone.
taste abnormality; soar throat; numb throat; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of TASTE DISORDER (taste abnormality), OROPHARYNGEAL PAIN (soar throat) and OROPHARYNGEAL DISCOMFORT (numb throat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TASTE DISORDER (taste abnormality), OROPHARYNGEAL PAIN (soar throat) and OROPHARYNGEAL DISCOMFORT (numb throat). At the time of the report, TASTE DISORDER (taste abnormality), OROPHARYNGEAL PAIN (soar throat) and OROPHARYNGEAL DISCOMFORT (numb throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   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.; Reporter'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.
Night of vax pt. awaken with pain, nausea, shaking, forgetful, memory delay, weak and swelling in the back of the head in the neck indentation with migraines and light sensitivity. Says swelling stayed 4 days. Pt. still having some symptoms of headaches and sensitivity to light as well as no energy and weakness. Pt. lives alone, she called dr. office 1 week after vax.
Localized 2-3 inch in diameter- red/swollen w/nausea & dry heaves X 2 days.  Extreme fatigue
This is an initial spontaneous report by a contactable physician. This physician reported on behalf of a patient who received a dose (reported as 1x/2months) of PREVENAR 13 administered intramuscularly in anterolateral femoral skin flap to prevent pneumococcal infection on an unspecified date in Apr2011. Relevant medical history included hemophilia factor-5 deficiency. Relevant concomitant medications were none. In Jun2011 the patient developed hematoma at the sight of injection of PREVNAR-13. Relevant lab data was none. At the time of report the patient had recovered from hematoma in Jun2011. Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of PREVENAR 13.
pt became nauseated & passed out w/in 2min p/vax;pt was brought into clinic room & ammonia was used to bring back;awakened & then lost consciousness again;c/o chest pain, arm pain & throat pain;BP 123/89 & pulse 100;epi given & DPH;
Note: my first 2 series in my COVID-19 vaccine was Pfizer.  I decided to cross boost. Approximately 36 hours after receiving a Moderna COVID-19 booster, along with the typical side effects (sore arm, swollen lymph nodes, chills) I had a burning pain that would come and go about every 10 minutes way down in my lower right pelvis region (felt like ovary/fallopian tube area). This pain and burning went on all day.  12 hours. The next day it was completely gone. I knew it was related to my booster. I never felt this burning pain before.
Pt recv'd Hep B & pneumonia vax on 11/1/99.Later that evening, pt experienced seizures.Pt does have a history of seizures.
fever, body aches, and headache on 04/11/2020.  was instructed to take tylenol and to apply cold compress. patient was instructed to seek medical attention if the symptoms got worse.
After receiving the COVID-19 vaccine, the client verbalized lightheadedness.  Client was evaluated by onsite Fire Rescue.  Client symptoms resolved within 15 mins. Client was released to go home at 2:34 pm by Fire Rescue.
He had a reaction, his tongue was swelling on the left side; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (BNT162B2, Pfizer Covid-19 vaccine), dose 1 via an unspecified route of administration on an unspecified date (Lot Number: EP6955) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had a reaction, his tongue was swelling on the left side on 21Mar2021 (not clarified further). Also, like two days after like on the 23rd, patient woke up at 8:30 and his tongue was swollen. So, reporter had to give patient Benadryl (treatment) and it did go down. The outcome was recovered.  No follow-up attempts are needed. No further information is expected.
Tachycardia for 5 hours. Onset several hours after injection.  After that, irregular pulse for at least 2 weeks on and off.  Abnormal mammogram 2 weeks after injection with inflamed lymph left breast, same side as injection. Confirmed by Radiologist that they had been seeing the swollen nodes in breast caused by vaccine. Also had several small blood clots to inside left cheek of mouth resolved after 3 days.
Upper left arm at injection site red, swollen, warm and pain. Area swollen approximately 7cm.
Pt received vaccines 8/1/2012. Came back to clinic 8/3/12 with mild erythema & redness to posterior left arm.
This is a spontaneous report from a contactable consumer. An adult female patient (late 50s or early 60s) received PREVNAR 13 via an unspecified route of administration, on an unspecified date in Sep2015 at single dose for immunization. Relevant medical history and concomitant medication was not reported. The patient almost passed out on unknown date and she had to be picked up, taken to emergency room and she received BENADRYL shots. The patient was not admitted to the hospital. The outcome of the event was unknown. Follow-up (29MAY2016): Follow-up attempts are completed. No further information is expected.
Myocarditis inflammation; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (Myocarditis inflammation) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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 MYOCARDITIS (Myocarditis inflammation) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Myocarditis inflammation) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Heart rate: 130 (High) heart rate around 130.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported. "Patient mentions another girl at the hospital (patient 2, reported in a crosslinked case) experienced accelerated the heat rate around 130, in January, and now has to see a cardiologist all the time for a  myocarditis inflammation caused by the vaccine."  Company Comment: Very limited information regarding this event has been provided at this time.; Sender's Comments: Very limited information regarding this event has been provided at this time.
Moderna COVID-19 Vaccine EUA. Headache; fatigue; muscle & body ache; shortness of breath; chills. Duration 48 hours.
a eight years old female patient got her first dose of TD vaccine but did not get the other doses of the vaccine/No AE; Initial information received on 19-Nov-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a eight years old female patient who received vaccine DIPHTHERIA AND TETANUS TOXOIDS [DIPHTHERIA AND TETANUS TOXOIDS] of unknown manufacturer, batch number and expiry not reported and that she will not get anything except the adacel since she has had 3 Polio, 2 MMR and HEP A at other visits on an unknown date via unknown route and site of administration.(Caller states the school systems are so strict that the father has been to school several times and they will not let her go to school unless she has had the doses needed. States she will not get anything else today except the Adacel since she has had 3 Polio, 2 MMR and Hep A at other visits- as reported).  The patient's past medical history, medical treatment(s) and family history were not provided.   It was a case of actual medication error due to inappropriate schedule of vaccine administered.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  Information on the batch number was requested.
I experienced pityriasis and am still currently experiencing psoriasis or other like illness in my scalp and it is extreme.
Pt received immunization @ 1220 she was monitored after immunization for 15min with no side effects. States she went to bed around 9:30pm, was unable to fall asleep.  Developed shaking, chills, sweats and fever 101.5 @ 2am. Did take ibuprofen, some relief from shaking. Continues to have fever, bodyaches, joint pain, chills & sweating.
Case number PHEH2015US01956, is an initial spontaneous report received from a healthcare professional on 30 Sep 2015. This report refers to a 56 year old female patient. Historical conditions and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX (batch number: 173539) intramuscularly at a dose of 0.5 ml on 23 Sep 2015. It was reported that, before administration, the FLUCELVAX was stored at room temperature for 24 hours. No adverse event was reported following this medication error.
This spontaneous report was received from a physician via a company representative, concerning a currently 75 year old female patient. The patient's medical history, concurrent conditions and concomitant therapy were not provided. On an unspecified date in 2009, the patient was vaccinated with ZOSTAVAX injection for prevention of shingles. (Strength, dose, route, lot number and expiration date were not reported). On an unspecified date (reporter as recently), the patient had a severe breakthrough case of shingles. The patient sought medical attention and sawthe physician; who treated patient with unspecified antivirals but any other treatment was unknown by the physician. It was unknown if lab test were performed. At the time of reporting, the patient had not recovered from the event. The causal relationship between ZOSTAVAX and the event was not provided. Additional information has been requested.
Information has been received from an occupational therapist referring to her daughter, a female patient of unknown age with allergic to soy and beef. The patient had no pertinent medical history. On unspecified dates the patient received three doses of LIQUID PEDVAXHIB (lot#, dose, frequency not reported, for vaccination). The therapist added that the patient also received PREVNAR concomitant with LIQUID PEDVAXHIB (also reported that there was no concomitant medication), but she was not sure how many doses of PREVNAR were administered. The therapist reported that the patient experienced severe abdominal pain and upper respiratory infection (dates unspecified) after each of three doses of LIQUID PEDVAXHIB. The abdominal pain and upper respiratory infections resolved on unknown dates without requiring medical treatment. No lab diagnostics studies were performed. The patient had sought medical attention via office visit with unspecified physician. Additional information has been requested.
Information has been received from a registered nurse referring to a 4 years old patient. Information about pertinent medical history, concurrent conditions, concomitant medication and drug reactions/allergies was not provided. On 14-FEB-2019, during the same office visit, the patient was inadvertently administered a pediatric dose of RECOMBIVAX HB (thimerosal-free) (route: intramuscular, lot # : R00674, expiration date : 09-NOV-2020; strength: 5/0.5 mcrg/ml) and a dose of PEDIARIX (lot #, expiration date, dose, strength, route, and frequency were not reported) for prophylaxis (accidental overdose). No adverse effects were reported in the patient.
1 day post FLUMIST administration, student started wheezing. Seen by PCP, treated with albuterol via nebulization and sent home with albuterol inhaler. Seen by PCP for follow-up mild cough possible R.A.D.
Low sex drive; No stamina; This spontaneous case was reported by a pharmacist and describes the occurrence of LIBIDO DECREASED (Low sex drive) and ASTHENIA (No stamina) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIBIDO DECREASED (Low sex drive) and ASTHENIA (No stamina). At the time of the report, LIBIDO DECREASED (Low sex drive) and ASTHENIA (No stamina) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  No treatment details were provided.
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 38-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported. The vaccines was stored in freezer, and was taken out one to two vials and place in fridge each day as needed.
Resident had completed Pfizer Covid 2 dose series plus 1 booster dose (Dates:  1/15/21; 02/15/21; 09/28/21). At clinic to receive a influenza vaccine. Vaccinator administered an additional Pfizer Covid  in error.  This would represent a 4th dose. Error realized. Patient notified.  Correct vaccine (influenza High dose) was administered.   Follow up with patient the next day.  No adverse reactions.
Pt reports that he had diarrhea that began 1 week after receiving first dose of Covid vaccine by Moderna. Pt received the second dose of Covid vaccine on 1/1/25/2021. Pt states that even after 2 weeks after receiving the second dose of Covid vaccine by Moderna the diarrhea has continued. Pt reports not issues with diarrhea prior to receiving the Covid vaccine by Moderna.
Pt reports PMH of tinnitus since 20 YO. He states about a year ago, he had a sore throat and saw Dr. His Dr. checked for strep, which was negative, but he didn't check for COVID. However, since that illness, his tinnitus has worsened. Then, since his first dose of COVID-19 vaccine, pt said his tinnitus has worsened/changed. He is now "hearing additional tones" and "it's more sensitive now".  Patient will continue to monitor and follow up with Dr. if necessary.
15 minute seizure approx. 21 hours after receiving Proquad and Kinrix vaccines. Seizure responded to Diastat. Has had 12 febrile seizures in past and seen Neurology.
Systemic: Fainting / Unresponsive-Severe, Additional Details: THE PATIENT DESCRIBED FEELING LIGHTHEADED AFTER HIS VACCINATION. HE BECAME ALMOST UNRESPONSIVE WHILE SITTING IN THE VACCINE ADMINISTRATION AREA WHEREBY I WENT TO GET a staff member FOR ASSISTANCE. WE WERE ABLE TO GET THE PATIENT INTO A SUPINE POSITION AND staff member MEASURED HIS BLOOD PRESSURE, WHICH WAS APPROXIMATELY 70/50. Staff member WAS UNABLE TO GET A O2 READING ON THE PULSOXIMETER AT WHICH POINT WE CALLED 911. THE PATIENT LEFT ON HIS OWN AFTER EVALUATION BY THE EMTS.
Developed swollen reddened area on outer thigh at site of immunization of PCV and Hib received on 3-13-07. Grandmother reports child had a seizure. Was in ER on 3/14/07 at 22:27.
A non-serious spontaneous report of patient licked dripping vaccine, sores on inside of mouth, sores on tongue, slight redness to face and sore throat has been received from a pharmacist concerning her 25-year-old husband, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. On 9-Nov-2009, the patient received H1N1, Intranasal for an unknown indication. On 9-Nov-2009, the patient was requested to inhale deeply upon receiving the H1N1. Upon administration, the mist began to drip out of the nose. The nurse administering the vaccine told patient to lick the dripping vaccine to ensure full dose. Within hours, the patient reported sores on inside of mouth and tongue, slight redness to face, and sore throat. The symptoms were ongoing at the time of report and were treated with ibuprofen. The outcome of the events was not recovered at the time of reporting.