chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a licensed vocational nurse refers to multiple unspecified patients. The patient's concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients received improperly stored VARIVAX (Merck) (lot # reported as L043624, expiry date 03-NOV-2017 and lot # reported as L040419, expiry date 14-OCT-2017) (dose, route and site of administration were not reported). No adverse effects were reported. Temperature excursion was noted as 11 Fahrenheit for 40 minutes. Also, previous temperature excursion was reported as multiple defrost cycles. This is one of two reports received from the same reporter. Additional information has been requested.
Nurses please be on the alert as you give flu vaccine, today we had one that seemed to have a broken spot under the end piece where you have the screw hub meet the smooth syringe. When the nurse went to inject a spray came out sideways across the room. We are confident this was not the needle but rather something in the syringe. Please if you see anything further let me know. We have looked at the rest of the box with no indication of issue- so possibly it was when the nurse pushed down to twist the needle on it caused a slight crack?
Information has been received from a physician concerning a patient who was vaccinated with a dose of Gardasil.  The physician reported that the patient experienced asthma after vaccination.  The physician also reported that the patient was "fine."  Additional information has been requested.
The shipment of vaccine was received outside the 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside the 72 hour guideline and was potentially compromised, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via The Agency (Reference number- 00303291) and transmitted to Sanofi on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310352, 2020SA310901, 2020SA310354, 2020SA310460, 2020SA310461, 2020SA310462, 2020SA310463, 2020SA310464, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310559, 2020SA310704, 2020SA310705, 2020SA277871, 2020SA310706, 2020SA310707, 2020SA310708, 2020SA310760, 2020SA310759, 2020SA310762, 2020SA310761, 2020SA310764, 2020SA310765, 2020SA310766, 2020SA310767, 2020SA310768, 2020SA310769 and 2020SA310770 (same reporter).  This case involves a patient (demographics unknown) who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ505AA, expiry date: 30-Jun-2021, form: prefilled syringe) via an unknown route in unknown administration site for prophylactic vaccination on 05-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised (product storage error and product distribution issue).  It was a case of an actual medication error due to incorrect product storage.  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hour guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product. No thermometer was in packaging and product was cold when they received it.  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 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.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a female patient who received SHINGRIX (batch number G47M2, expiry date 11th October 2020) and (batch number 5NY3B, expiry date 13th July 2020). On 27th April 2018, the patient received SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. On 29th April 2018, 2 days after receiving SHINGRIX, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was not recovered/not resolved. The reporter considered the injection site rash to be possibly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Pharmacist reported that they had a SHINGRIX clinic on Friday (27th April 2018). Three of her patients returned to her pharmacy on reporting date with the same symptoms. All three patients were female. The reporter did not have additional details to differentiate one patient from the other. They used two different lot number of SHINGRIX. This case has been linked with case US2018GSK080994 and US2018GSK080995, reported by the same reporter.
pt recvd vax 8JUL92 & in approx 4 hrs pt's leg @ DTaP site devel localized hives (6 or 7 hives of approx 4-5 in diameter each), tenderness & induration of 4 cm in diameter; tx included ice & Atarax; resolving;
Information has been received from a female consumer concerning her 14 year old daughter with no known allergies and no reported medical history, who in October 2007, was vaccinated with Gardasil vaccine. There were no concomitant medications. The mother reported that on approximately 19-OCT-2007, her daughter received her first dose of vaccine. On approximately 22-OCT-2007, her daughter started experiencing heat inside her body and her face and chest would turn bright red for about 3 minutes. The mother also reported her daughter had same symptoms almost everyday until today,  30-OCT-2007. The mother could not reach the daughter's physician for consultation. No further information has been provided. Additional information not expected.
A report was received from a health care professional on 11/21/2002 concerning eleven vaccinees between the ages of 56-84 years who were inadvertently administered 1ml Fluvirin on and unreported date. On an unreported date eleven vaccinees were inadvertently administered 1ml Fluvirin. No adverse reaction was reported. There was insufficient information to determine the reporters causality assessment. Update1 12/31/2002: A follow up report was received from a health care professional indicated that a 65 year old male vaccinee was inadvertently administered 1.0 ml Fluvirin on 11/23/2002. Cross Reference with: PJP200200906, PJP200200905, PJP200200904, PJP200200903, PJP200200902, PJP200200901, PJP200200900, PJP200200899, PJP200200898, PJP00907.
Initial unsolicited report received from a consumer on 05-Oct-2015. This case involves a 92 years old female patient who was vaccinated with a dose of FLUZONE HD via intramuscular route in the right shoulder (batch number, expiry date were not reported) on an unspecified date in Sep 2015. Previous dose was reported as yes. The patient had no illness at time of vaccination. There was no known allergy and he had arthritis in the hands. Concomitant medications were not reported. On unspecified date in Sep 2015, one day post vaccination, the patient developed pain at site, it was reported that the vaccine was given in her shoulder, not the deltoid. The pain had persisited with "ten on a scale of ten at times". She was seen by her orthopedist who stated the pain was due to the vaccine. The patient stated she cannot move her arm the full ROM (Range Of Motion), she was unable to play tennis and could not get dressed without help. The patient took tylenol (Over The Counter) as corrective treatment. Laboratory tests were not reported. She required ER/doctor visit. The patient had not yet recovered from the above mentioned events. List of documents held by sender: none.
Member called to report one sided shoulder/neck/chest soreness 1 day after Anthrax vaccination. Patient denied any redness, swelling, signs of allergic reaction, fever, or any other symptoms aside from discomfort. Provided patient education on normal Anthrax vaccination side effects and advised member to report to ER if chest discomfort is present. Advised member that a VAERS will be submitted.
Patient reported dizziness and nausea after received vaccine about 9 minutes after receiving vaccine. Patient was sweating and pale.
Muscle sourness; lethargy; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the right arm on 22May2021 at 09:30 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 23May2021, the day after vaccination, the patient experienced muscle sourness and lethargy. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. 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 muscle sourness and lethargy were resolved in May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Severe diarrhea, no stomach cramps or warning, it just happened. It only lasted about 39 minutes, not a big deal, but I didn?t know that was a possible side effect. I hadn?t eaten all day so it couldn?t have been food related. I?m not upset at all and I?m looking forward to being fully vaccinated next mont, I just thought it might help if others are having this reaction to list as possible side effect?
No additional AE; Nurse reporting an AE for PEDVAXHIB and ROTATEQ being administered after a temperature excursion that occurred on 05-OCT-2022.; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 05-OCT-2022, the patient was vaccinated with improperly stored (product storage error) doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter, lot #: 1879874, expiration date: 19-OCT-2023; and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 milliliter, lot #: U039951, expiration date: 22-JUN-2024 (strengths, sites and routes of administration were not provided for both suspect vaccines) for prophylaxis. Temperature excursion information for haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB): 47.4 degree Fahrenheit for 30 minutes; previous temperature excursion: approximately August 2022, 49.8 degree Fahrenheit for 2 hours 25 minutes. Temperature excursion information for rotavirus vaccine, live, oral, pentavalent (ROTATEQ): 47.4 degree Fahrenheit for 30 minutes; no previous temperature excursion. There was no additional adverse event reported.
Some time post vax, the pt reported developing debilitating arthritis as well as full-blown Lyme disease.
Chief complaint of mild nasal congestion and cough. Symptoms began about 3 days ago. Fever has been high-grade. Other associated symptoms include: nosiy breathing at night. High fever 3 days, bronchitis the fever and cough came after the vaccine.
Once the shot when in, no asperation done.  Then I felt a warmth go around my arm in the area it was given, like someone grabbed my arm.  This lasted about 5 hours.  Only slight pain in the injection site for 4 days.  I also had a rush of warmth and fast heart beat 5 min. after the shot.  it lasted about 3 min.
Pt developed mac-pap rash on both thighs the day immunizations given. He was very fussy and scratching legs. He had similar rash 1-2 days after 2 month immunizations.
Patient felt like he was go to pass out. Patient turned pale white and said he felt lightheaded.
Primary series of Pfizer Covid 19 vaccine on 8 MAR 2021 followed by two dose series of Moderna Covid 19 vaccine that was completed the end of MAY 2021; Primary series of Pfizer Covid 19 vaccine on 8 MAR 2021 followed by two dose series of Moderna Covid 19 vaccine that was completed the end of MAY 2021; Interchange of vaccine products; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (Primary series of Pfizer Covid 19 vaccine on 8 MAR 2021 followed by two dose series of Moderna Covid 19 vaccine that was completed the end of MAY 2021), COVID-19 IMMUNISATION (Primary series of Pfizer Covid 19 vaccine on 8 MAR 2021 followed by two dose series of Moderna Covid 19 vaccine that was completed the end of MAY 2021), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) for an unknown indication.    No Medical History information was reported.   On 08-Mar-2021, the patient received second dose of TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form. In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of TOZINAMERAN (COMIRNATY) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Primary series of Pfizer Covid 19 vaccine on 8 MAR 2021 followed by two dose series of Moderna Covid 19 vaccine that was completed the end of MAY 2021), COVID-19 IMMUNISATION (Primary series of Pfizer Covid 19 vaccine on 8 MAR 2021 followed by two dose series of Moderna Covid 19 vaccine that was completed the end of MAY 2021), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Primary series of Pfizer Covid 19 vaccine on 8 MAR 2021 followed by two dose series of Moderna Covid 19 vaccine that was completed the end of MAY 2021), COVID-19 IMMUNISATION (Primary series of Pfizer Covid 19 vaccine on 8 MAR 2021 followed by two dose series of Moderna Covid 19 vaccine that was completed the end of MAY 2021), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. No concomitant medication was provided. No treatment medication was provided. The patient was completed primary series of Pfizer Covid 19 vaccine on 8-Mar-2021 followed by two dose series of Moderna Covid 19 vaccine that was completed the end of MAY 2021.
This spontaneous report as received from a physician refers to a patient of unknown age who on 20-JUN-2011 was vaccinated with the first dose of GARDASIL (lot number not reported). Physician mentioned "a patient was received the 2nd dose of GARDASIL (lot # is unknown) early on 08-AUG-2011, and the 3rd dose of GARDASIL (lot # is unknown) late on 14-JUL-2012". "The patient is not experiencing any known symptom". No treatment information was reported. Additional information has been requested.
10/17-10/19-headache, dizziness; 10/19-nausea.
Arm still sore / hand is hurting for 3 weeks now; Arm is hard; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm still sore / hand is hurting for 3 weeks now) and INDURATION (Arm is hard) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     Medical history has not been reported.  Concomitant products included ADALIMUMAB (HUMIRA), METHOTREXATE SODIUM (METOTREXATE), ASPIRIN [ACETYLSALICYLIC ACID], COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), VITAMIN C [ASCORBIC ACID], LEVOTHYROXINE and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm still sore / hand is hurting for 3 weeks now) and INDURATION (Arm is hard). At the time of the report, PAIN IN EXTREMITY (Arm still sore / hand is hurting for 3 weeks now) and INDURATION (Arm is hard) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional concomitant medication included cholesterol medication.  Patient did not seek any treatment.
Pt developed a 5 inch erythemic, hot rash from the point of DTAP injection site.
Patient w/ L sided heart palpitations after COVID-19 vaccine 2/8/21. First episode lasted 4-5 hours: BP=113/78, HR=78, O2=96. Happened a few hours after second dose of vaccine as well (3/1/21). He visited PCP and was stable.
Unable to use left shoulder joint at all for 36 hours...totally frozen. Severe pain for 24 hours controlled w TYLENOL 1000mg q4h. Iced area for 12 hours. Bedrest. Started easy into movement in 3 days and able to use joint in 5 days. Continues to be tender at 1 week.
Arm has a strange rash/bruise at site of injection; Arm has a strange rash/bruise at site of injection; Current age-7; Current age-7; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 7 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Nov2021 (Batch/Lot number: unknown) at the age of 7 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE BRUISING (non-serious), VACCINATION SITE RASH (non-serious) all with onset 13Nov2021, outcome "not recovered" and all described as "Arm has a strange rash/bruise at site of injection"; PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious) all with onset 08Nov2021, outcome "unknown" and all described as "Current age-7". Therapeutic measures were not taken as a result of vaccination site bruising, vaccination site rash.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Known allergies reported as NKNDA. The patient had not received any other vaccine within 4 weeks and not received any other medications in two weeks.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient had a seizure on Sunday May 29th two days later at 5am ? eyes rolled in the back of his head? foaming at his mouth. ? and joints completely stiff. This was his first time having a seizure
pt brought to hosp after dialysis due to weakness, N/V, altered mental state; positive for COVIDO2 supplementation; CXR showed right sided pleural effusion and increased densities; intubated; pt suffered cardiac arrest, ACLS performed without success; pt passed away in the hospital
Numbness on left side face; Numbness on Left foot; Numbness on left shoulder; Numbness on left arm and shoulder; Numbness of left leg; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HYPOAESTHESIA (Numbness on left side face), HYPOAESTHESIA (Numbness on Left foot), HYPOAESTHESIA (Numbness on left shoulder), HYPOAESTHESIA (Numbness on left arm and shoulder) and HYPOAESTHESIA (Numbness of left leg) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced HYPOAESTHESIA (Numbness on left side face), HYPOAESTHESIA (Numbness on Left foot), HYPOAESTHESIA (Numbness on left shoulder), HYPOAESTHESIA (Numbness on left arm and shoulder) and HYPOAESTHESIA (Numbness of left leg). On 14-Mar-2021, HYPOAESTHESIA (Numbness on left side face), HYPOAESTHESIA (Numbness on Left foot), HYPOAESTHESIA (Numbness on left shoulder), HYPOAESTHESIA (Numbness on left arm and shoulder) and HYPOAESTHESIA (Numbness of left leg) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported by the reporter. Treatment information were not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow-up information received on 23-JUN-2021and contains significant information. Updated patient demographics, second dose details, outcome and stop date of the event.
A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning an eight-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
This case was reported by a consumer via call center representative and described the occurrence of headache in a 68-year-old female patient who received SHINGRIX for prophylaxis. On 30th July 2018, the patient received the 2nd dose of SHINGRIX. In July 2018, less than a week after receiving SHINGRIX, the patient experienced headache, fever, shivering and muscle pain. On an unknown date, the outcome of the headache, fever, shivering and muscle pain were recovering/resolving. It was unknown if the reporter considered the headache, fever, shivering and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The patient's symptoms were improved, especially compared to a day before the date of reporting.
Patient had a fever of 103.4 F and blotches on stomach on 6-18-11.
Noticed a raised rash on leg and buttock of injection site then spread to other leg. Went to ED and they gave him Benadryl hives started to disappear and then were back in the morning on the legs and arms.
Syncope, pt. passed out while standing. Unsure if struck head. Loss of consciousness, vomit x1.
Information has been received from a medical assistant referring to a 6 month old female patient. No relevant medical history or concurrent conditions were reported. On 06-JUL-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322. Additional information has been requested.
Bleeding at injection site upon receiving vaccine; sore arm; aches and pains; chills 20 hours after vaccine
c/o of head hurting about 1 1/2 hrs p/shot, started w/temp about 3 hrs p/temp cont to early AM next day highest t104 ax; vomited x 3 about 6 hrs; p/shot seemed to hallucinate, was groggy the next day didn't sleep well noc a/;