chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt waited her 15 minute timeframe, then returned to work with no adverse reactions. Upon returning to work in the pharmacy, she sat down at her desk and noted her HR to be 159 via her Apple watch. She felt slightly lightheaded, so returned to  Auditorium for monitoring. On arrival, she complained only of high HR, no other symptoms. We checked her VS: BP 140/78, HR 132, RR 20, SaO2 94. She denied chest pain or SOB. We monitored her for about 15 minutes, and her HR decreased to 103-110. We monitored her for another 15 minutes or so, at which time her HR spiked again to 132, and she felt heavy in her chest and tight in her throat. At that point, we moved her to a gurney and called a Rapid Response. We administered 50mg of Benadryl IM per protocol, foregoing the Epinephrine, due to her tachycardic state. The Rapid Response team arrived and she was transported to the ED for evaluation. She maintained consciousness and was A&Ox3 the entire time.
Pt developed screaming starting shortly post vax until 10 PM. He would settle down for a few minutes a couple of times. He developed fever to 101 all evening. The next day, he wanted mother to hold him. He was very listless and and "eyes glassy."
Hives and itchy skin a couple of days after the vaccine was administered and continuing for more than two weeks
Erythema at site (left arm) warm, non tender.  Treatment: compresses.
SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. 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 were not reported, batch number: 207A21A, expiry: unknown) dose not reported, 01 total, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient felt like flu instead of pneumonia (suspected covid-19 infection). On an unspecified date in DEC-2021, the patient tested positive for Coronavirus disease (covid-19) (suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was unknown. This report was serious (Other Medically Important Condition). This case is associated with a product quality complaint: 90000214926. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20220200721.; Sender's Comments: V0-20220200531-Covid-19 vaccine ad26.CoV-2.s- Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
He received the shot on 8/7/07. Two weeks later he broke out in chickenpox, high fever-duration 1 week I did call the clinic to report it.
This case was reported by a physician via sales rep and described the occurrence of fever in a male patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 12 hrs after receiving SHINGRIX, the patient experienced fever, On an unknown date, the outcome of the fever was recovered/resolved. It as unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: The reporting physician was the patient. The age at vaccination was not reported. The patient developed fever with body temperature of 102. 4 degree Fahrenheit, 12 hours later. The fever resolved by 36 hours after injection. The reporter agreed to be contacted for follow up.
coughing; tender arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (tender arm) and COUGH (coughing) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), ACETYLSALICYLIC ACID (BABY ASPIRIN), OMEPRAZOLE, LEVOTHYROXINE SODIUM (LEVOTIROXIN), TOLTERODINE and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (tender arm). On 14-Feb-2021, the patient experienced COUGH (coughing). At the time of the report, PAIN IN EXTREMITY (tender arm) and COUGH (coughing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, SARS-CoV-2 test: positive (Positive) positive. On 27-Feb-2021, SARS-CoV-2 antibody test: negative (Negative) negative- she had no immunity.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 21Jan2021 the patient  tested positive to COVID-19.  On 25Jan2021 the patient was in ER, she was eligible for antibodies and got them on 27Feb2021. She received the clearance from a doctor to discontinue the isolation.  Tx: Antibodies  On 18Feb2021 the patient went to take her second shot which was denied as "she had no immunity" and that she "had to wait 90 days from the antibodies. It was reported that patient had a schedule for a stomach procedure.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: email address updated
"Moderna COVID-19 Vaccine EUA"  After I took the Moderna vaccine there was swelling and pain in my left knee. The swelling makes it difficult to walk and bend at that knee.
This spontaneous report was received from a healthcare worker regarding a approximately 5 year old patient of unknown sex. On 04-MAR-2015, the patient was vaccinated with expired dose of VARIVAX, lot number- J002318, expiration date- 22-FEB-2015, .5 ml, subcutaneous. No adverse event was reported. No concomitant medication was reported. No product quality complaint was involved. It was reported that potency was supported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Pt has been diagnosed with cellulitis at injection site. Placed on KEFLEX for 10 days. The area has reduced in size and redness significantly.
Case number PHEH2012US020375 is an initial spontaneous report received from a nurse on 16 Oct 2012 and with a follow up received on 16 Oct 2012. This case refers to a 50-year-old female patient. The patient was allergic to penicillin. She was vaccinated with FLUVIRIN (batch number: 1206501) intramuscular on 15 Oct 2012 and developed fuzzy tongue, furry and swollen tongue on an unspecified date. She took BENADRYL and was doing fine at the time of this report. The event outcome, seriousness and causality assessment was not reported. No other information was available. Follow up report received on 16 Oct 2012. Updated vaccination route and batch number. Added event swollen tongue.
Soreness at injection site, hoarseness, fever, severe chills, aches over entire body, severe headache, sporadic itching, could not sleep all night, fatigues for several days, gum infection on 3rd day.
From initial information received on 11/3/03 from a health care professional, regarding an adverse event occurring in the USA, it was reported that a 48 year old female patient received FLUZONE, lot number U1271AA, administered IM in the left deltoid on 10/31/03 at 7:50 AM. Immediately following administration of the product, the patient complained of feeling faint. Approximately one minute after sitting her down, she went into anaphylaxis and had a loss of pulse and breathing. She was pale, cool and clammy. Epinephrine .2 cc was administered SC and the patient responded in approximately 30 seconds. The patient was transported to the hospital and was seen in the ER. The patient reportedly did recover from this event. (OMIC)  Follow up on 01/09/04: "From additional information received on 12/29/03 from mail correspondence received from the initial reporter, the ER physician and telephone number where the pt was treated was provided.  It was also reported that the ER records were not available and that this pt had no previous influenza immunizations.  The adverse reaction lasted approximately three minutes.  The reporter states that this pt initially stated there were no known allergies, but in a recent conversation stated she had an allergy to sulfa drugs.  No allergy testing was performed.  The reporter stated, "Reviewed, no additional information at this time."  No additional information is expected, therefore, this case is considered closed." 60-day follow up on 02/11/04: "Pt has recovered from adverse event. Per conversation, she has been monitored (by her family doctor) for a possible irregular heartbeat-the results being inconclusive."
Head Ache; Chills; Fever of 101 Degrees Farenheight; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 101 Degrees Farenheight), MYALGIA (Body ache), HEADACHE (Head Ache) and CHILLS (Chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever of 101 Degrees Farenheight), MYALGIA (Body ache), HEADACHE (Head Ache) and CHILLS (Chills). At the time of the report, PYREXIA (Fever of 101 Degrees Farenheight), MYALGIA (Body ache), HEADACHE (Head Ache) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.   Reporter did not allow further contact
December 1, 2021 Vaccine vial moved from freezer to fridge January 6, 2022 Vaccine administered.
Patient received Moderna vaccine on 12/23/20 at approximately 1530. No adverse events observed immediately following injection. Approximately 12 hours later (12/24/2020 @ 0300) patient developed fever, chills, body aches, fatigue and headache that last for approximately 24 hours. On 12/24/2020 @ 1200 patient experienced near syncopal episode. On 12/24/20 @ 1500 patient developed hive on b/l legs and arms. Symptoms treated with motrin and benadryl. All symptoms resolved by 12/25/2020
c.o irritability in pt 2 hrs p/vax given took pt to ER t99.9; pt crying;
Within 1 hour of vaccine became inconsolable, refusing feeds. Take to the ER - no fever but the right thigh had become edematous, 60% of the skin on the right thigh centered at the vaccine site was intensely erythematous. Treated with TYLENOL & BENADRYL. Gradually improved over 24 hours.
2 days of increasing redness upt to 3x4 cm, swelling, and tenderness.  Treated for cellulitis with Duracef.
Feeling cold despite warm room and clothing starting about 10 hours after injection. Uncontrollable shivering starting about 12 hours after injection and lasting an hour, nausea, headache, weakness, passed out when I got out of bed the next morning, exhaustion and diarrhea lasting two days.
This spontaneous report was received from a medical assistant regarding an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, drug allergies or concomitant therapies were not reported. On unspecified dates, patients were vaccinated with improperly-stored doses of GARDASIL 9 injection, (strength and dose were not reported) (lot # M017983, expiration date 30-MAY-2018) for prophylaxis. According to the reporter, GARDASIL 9 doses were exposed to the following temperature excursions: 51 hours between 32 degrees Fahrenheit (F) and 35F, and for 14 hours and 15 minutes between 47F and 77F (60F). No adverse effects were reported. A digital data logger was involved. This is one of several reports from the same reporter. Additional information is not expected as the reporter refused additional contact.; Sender's Comments: US-009507513-1705USA000386: US-009507513-1705USA000339:
Began experiencing throbbing  pain about 15 min after the injection that radiated down the entirety  of the arm along with a headache and tunnel vision. The headache dissipated about 4 hours later  and the tunnel vision dissipated about  30 min later. The pain and throbbing  the arm lessen but the days to follow I did notice a loss of strength to my forearm as with as the tricep and bicep although there was no swelling on the injection site.  The days to follow I applied heat, cbc, to try and heal alleviate the discomfort but have yet to fully gain the strength back in my arm. Some days are worse then others.  About 2 weeks after the injection I began experiencing  SOB and pain around my upper (r) ribcage, and shoulder.
Hospitalized for COVID with shortness of breath, chest pains, weakness, and confusion on 1/16/2022.
Product confusion; No additional AE/No PQC.; inappropriate age at vaccine administration; HCP called to report a product confusion AE with GARDASIL 9.  HCP stated that a 9 month old infant was inadvertently administered GARDASIL 9 today, July 19, 2023, instead of VAXNEUVANCE.  No additional adverse effects were reported.  HCP is also requ; This spontaneous report was received from Other Health Professional and refers to a 9-month-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 19-JUL-2023, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 ml, lot #W028573, expiration date: 06-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided). On an unknown date, the patient started therapy with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, , administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided).   On 19-JUL-2023, HCP called to report a product confusion AE with GARDASIL 9. HCP stated that a 9 month old infant was inadvertently administered GARDASIL 9 today, 19-JUL-2023, instead of VAXNEUVANCE. No additional adverse effects were reported. HCP is also requesting a callback from GMI to discuss potential safety issues and symptoms to watch for to identify any future adverse effects that might arise as a result of the inadvertent administration. Request case reference 02430672. Consent to contact is yes. No additional AE/No PQC
No adverse event; Patient received a 0.25 ml dose as booster from booster dose only presentation vial; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received a 0.25 ml dose as booster from booster dose only presentation vial) and NO ADVERSE EVENT (No adverse event) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In July 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In July 2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received a 0.25 ml dose as booster from booster dose only presentation vial). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received a 0.25 ml dose as booster from booster dose only presentation vial) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient received a 0.25 ml dose as booster from booster dose only presentation vial).    No concomitant product use was reported.  Vaccination dates reported as between 22-Jul-2022 and 28-Jul-2022. It was reported that the patient had received 0.25 ml (25 mcg) instead of 0.5 mL (50 mcg) as a booster dose. It was unknown if patient experienced any symptoms after getting the vaccine. Treatment information was unknown.
Within 30 minutes after Hep B #2 vaccine, the patient developed frontal headache, epigastric pain, and nausea, no emesis. History of the same symptoms after the flu vaccine 3 years ago.
Covid vaccine Pfizer ER8733 . Pt given vaccine and sent to seat. noted gait unsteady. pt seated and noted staring gaze .bp 121/93  HR 100 and reg. pt started to list to side. Placed on litter and taken to er. pt had some shaking  of extremities but was able to do some hand grasps on demand. placed in care of er staff. slow responses. husband with pt.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2009, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2016, the patient was treated for a persistent and severe vesicular rash, which was diagnosed as shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome is unknown. Additional information has been requested.
some slight irritation and scarring where the bumps were; bright red, itchy bumps forming on the inside of his right arm, rash continued to worsen over the next few days and spread to his chest and stomach; bright red, itchy bumps forming on the inside of his right arm, rash continued to worsen over the next few days and spread to his chest and stomach; Initial information received on 19-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 54 years old male patient who had bright red, itchy bumps forming on the inside of his right arm, rash continued to worsen over the next few days and spread to his chest and stomach (rash erythematous and rash pruritic) and some slight irritation and scarring where the bumps were (scar) after he received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's medical history, medical treatment(s), vaccination(s), family history and concomitant medication were not provided.  At the time of the event, the patient had ongoing high blood pressure.   On 01-Oct-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE, Prefilled syringe, lot number not reported via intramuscular route in the right deltoid for prophylactic vaccination.  On 01-Oct-2020, the patient developed bright red, itchy bumps forming on the inside of his right arm, rash continued to worsen over the next few days and spread to his chest and stomach (rash erythematous and rash pruritic) within a few hours following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Patient stated that he applied alcohol and calamine lotion to the area. He also reported taking Claritin which helped relieved symptoms. Patients stated that rash has gotten better, but still reported some slight irritation and scarring where the bumps were (Scar) unknown latency following vaccination.   Patient also reported that dark skin and rash was very red in comparison to his skin.  Relevant laboratory data was not reported.  The patient was recovering from rash erythematous and had not recovered from rash pruritic and Scar at the time of reporting.  There will be no information available on the batch number for this case.
Localized swelling, induration, erythema at left deltoid / sight of injection.
patient has NOT experienced any adverse events since; a 52 year old patient was administered PROQUAD; This spontaneous report was received from a physician referring to a 52-year-old female patient. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.   On 06-MAR-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), once, lot # reported as WQ029553 and expiration date reported as 14-MAR-2025, which was evaluated and changed to the valid lot #W029553, with expiration date: 14-MAR-2024, (dose and route were not provided) for prophylaxis (Product administered to patient of inappropriate age). The patient had not experienced any adverse events since (No adverse event).
Sore arm, medicine taste in the mouth, very hot and sweaty over the night, itchy foot and arm, hard to swallow my saliva, and the following day diarrhea, vertigo, nausea, fatigue.
Headache, arm pain, injection site swelling, site redness, site hardness, site pain, site itching, site rash <still spreading>, site expressing excessive heat, hot flashes, cold spells, body temperature irregularities
reports states  a hosp exp a failure to seroconvert in 50% of the patients;
This case was reported by a pharmacist via call center representative and described the occurrence of breast cancer in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 30 days after receiving SHINGRIX, the patient experienced breast cancer (serious criteria GSK medically significant). On an unknown date, the outcome of the breast cancer was unknown. The reporter considered the breast cancer to be unrelated to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was diagnosed with breast cancer about 1 month after receiving the first dose of SHINGRIX and would be undergoing treatment during the recommended time frame of the second dose of SHINGRIX. The healthcare professional inquired about the best time to give the patient their second dose of SHINGRIX.