chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 16-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.  It was unknown if the doses are first, second or third doses for the patients.   The vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions
Mom noticed small welts on her daughters face & chest; Next day covered w/welts & was very hot (mom did not take temp); To ER MD gave a shot DPH; Mom states MD said child had Stevens Johnson synd;
I had a lot of hives all over my body, & it was getting worse I noticed that when I touched anything it left a larger impression than without the hives, I could tell that some were pressure related so I went to urgent care & was given a Medrol for 6 days & later I went to ER where I was prescribed prednisone.
tiredness and fatigue; muscle aches/achiness; Nausea; Chills; intermittent headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tiredness and fatigue), MYALGIA (muscle aches/achiness), NAUSEA (Nausea), CHILLS (Chills) and HEADACHE (intermittent headache) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to UNK dosage form. On 01-Mar-2021, the patient experienced FATIGUE (tiredness and fatigue), MYALGIA (muscle aches/achiness), NAUSEA (Nausea), CHILLS (Chills) and HEADACHE (intermittent headache). At the time of the report, FATIGUE (tiredness and fatigue), MYALGIA (muscle aches/achiness), NAUSEA (Nausea), CHILLS (Chills) and HEADACHE (intermittent headache) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.   No concomitant medications were reported  Treatment with two doses Tylenol was given for these symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: Updated contact information and last name
Itching developed 5 hrs after injection around site of TD.  Then, about 12 hrs. after injection pain started, and then 24 hrs. after injection redness, warmth, and swelling developed.  Local reaction suspected but cellulitis could not be ruled out so VEFLEX were given for 10 days.
reports severe h/a & extreme sensitivity on skin especially on back;actually painful;sx began 1-2 days p/vax;
was not able to receive his second dose within standard time frame; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (was not able to receive his second dose within standard time frame) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (was not able to receive his second dose within standard time frame). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (was not able to receive his second dose within standard time frame) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient under age 18 was vaccinated with Moderna, which is a vaccine error, on 3/16/2021. Second vaccine provided 4/03/2021 - Pfizer EP EP6955. Troubleshooting: Scribe and vaccinator did not validate age;  screeners at the beginning of the process did not ask or turn away on a Moderna-only day. For the second error (Pfizer #2) scribe, screener, and vaccinator did not look at the vaccine card or the computer- there is only one record for this person. Unreported as error, found in data mining. Age restriction/confirmation rules were put into effect after the date of this vaccine to prevent underage vaccines.
This spontaneous report as received from a other health professional (Licensed practical nurse) refers to unspecified number of patients of unknown age. Current conditions and medical history was not reported. On an unknown date in 2014 (reported as since August 2014) the patients were vaccinated with PEDVAXHIB for an unknown indication (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. Since August 2014, the patients were administered improperly stored PEDVAXHIB. No adverse effects were reported. Outcome and causality assessment was not reported. Product quality complaint was not reported. No additional information reported. This is one of 2 reports received from the same reporter. Additional information has been requested.
-increased anxiety, had redness on left forearm and right forearm. After two days redness was gone.  -took Tylenol that night which helped.
After 35 min: Right side facial itching and "hives" on side of face. Back itching and "hives" reported on arrival to mother's house (about 5-10 minutes away). Took Benadryl PO and reports "relief." No airway issues (denied). Reported High blood pressure of "154 over 12...Something." Reports fever of 101 and chills for three days afterwards.  Also reports "red ring around injections site from the 2nd week up until 3/22/21."
Developing symptoms of covid/ symptoms of Covid after having the vaccine; Developing symptoms of covid/ symptoms of Covid after having the vaccine; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) lot number: EJ1688, via an unspecified route of administration in the left arm, on 21Dec2020 at a single dose for covid-19 immunisation as she works with disabled people and for general community health. Patient's medical history was none. Family history included her kids/children had covid (unknown if ongoing). There were no concomitant medications. It was reported that the patient had symptoms of covid after having the vaccine with outcome of recovering. The patient received the first dose of covid vaccine on 21Dec2020 and on the 02Jan2021 she started developing symptoms of covid. She mentioned that her children have virus and she had the covid test done. She wanted to know if she can get the second dose of the vaccine. She queried for her co-worker who has the Covid and was told to not take the vaccine yet and how long they need to wait. She was tested this morning. She has not gotten the results. Her kids had Covid and she felt certain she had it because she has symptoms. It comes and goes. It was better during the day and worse at night. She received the vaccine because she works with disabled people where there are extremely high numbers of the virus. She also got it for general community health. The Covid test was done on 06Jan2021 with unknown result.
48 years old patient was accidentally administered Fluzone High Dose on 24Sep2019, no AE; 48 years old patient was accidentally administered Fluzone High Dose on 24Sep2019, no AE; Initial information received on 25-Sep-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 48 years old male patient who was accidentally administered with a 0.5 mL dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ221AB, expiry date: 01-Apr-2020) via intramuscular route in the left deltoid on 24-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to inappropriate age at vaccine administration and overdose.  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.  Documents held by sender: none.
This is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 40-year-old female patients. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml 19 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursion lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
Injection site soreness- immediately after injection and lasted 48 hours  Fever 101 degrees - started 8 hours after shot and lasted 36 hours Chills - started 8 hours after shot for 24 hours  Body aches- started 8 hours after shot for 48 hours Nausea- started 8 hours after shot for 36 hours
About 5 minutes after the vaccine patient came to me because her arm was stinging/itching at the injection site. I checked the area and it was clear, no redness or swelling. As patient was explaining how it felt she became lightheaded and dizzy. She sat down and I monitored her symptoms. She was getting clammy, pale and nauseous. EMS was called and on scene within minutes and took over patient care.
Had flu shot (AFLURIA QUAD LOC: RA/LA - Lot YF41108 EXP 6/30/19 IM route MFG: Seqirus VIS 8/7/15 Dosage: 0.5 ml) at Pharmacy at 3 PM on 11/30/18. By 6 PM the same day, feeling symptoms of headache, muscle ache, nausea. Later that night, threw up and the next morning had diarrhea. Felt lethargic the next day 12/1/18, no appetite and continued diarrhea. 12/2/18 appetite returned, so ate "normal food" - threw up again that night. Diarrhea continued through 12/3/18. Ate bland diet 12/3/18 and did not throw up again. Still have a headache 12/4/18. Have had the flu shot every year for many years (20) and have never had any sort of reaction. Very strange, unusual and out of character for me and my body. I realize all symptoms are within the potential "adverse reactions", but wanted to report regardless as has never happened to me before and was relatively "severe", so not sure if something unusual or different with the vaccine this year? Additionally, I rarely get sick.
Got Influenza vaccine at 3:15pm 11/06/2002. Started itching at 6:30 pm and rash noticed 7:30pm. First developed small red hive left inner knee then it got larger in circular size and right knee hives appeared. took Benadryl 25mg at 11 pm. 11:30 rash over body, arms , and legs.
With 1st shot became nauseated, had slight headache and sweaty. Second shot, patient had no symptoms. With 3rd shot had real bad headache, cold chills and aching joints, that lasted 36 hours. One week later itching rash on back of neck and shoulders.
Site is swollen to the size of a tennis ball, red, warm to the touch, itchy and sore.
markings on his right legs; Felt a pinching feeling; Tired; Headache; On his left leg longer lines from 2 to 7 inches long  that looks like inflammation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Dec2022 at 15:00 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization, reaction(s): "Tired", "Headache", "On his left leg longer lines from 2 to 7 inches long  that looks like inflammation"; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization, reaction(s): "Tired", "Headache", "On his left leg longer lines from 2 to 7 inches long  that looks like inflammation"; Covid-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for COVID-19 Immunization, reaction(s): "Tired", "Headache", "On his left leg longer lines from 2 to 7 inches long  that looks like inflammation"; Covid-19 vaccine (DOSE 4, MANUFACTURER UNKNOWN), for COVID-19 Immunization, reaction(s): "Tired", "Headache", "On his left leg longer lines from 2 to 7 inches long  that looks like inflammation". The following information was reported: FEELING ABNORMAL (non-serious) with onset 07Dec2022, outcome "recovered" (Dec2022), described as "Felt a pinching feeling"; HEADACHE (non-serious) with onset Dec2022, outcome "unknown"; INFLAMMATION (non-serious) with onset Dec2022, outcome "unknown", described as "On his left leg longer lines from 2 to 7 inches long  that looks like inflammation"; FATIGUE (non-serious) with onset Dec2022, outcome "unknown", described as "Tired"; SKIN DISORDER (non-serious), outcome "unknown", described as "markings on his right legs ". Additional information: It was reported that, vaccine causes marking on the legs and doctor convinced it was from the vaccine. Patient experienced headache, gets tired, last for 24-36 hours, within an hour or two gets markings on his right legs which was verified with his doctor and were not blood clots, and on his left leg longer lines from 2 to 7 inches long that looks like inflammation which last for 3-4 weeks and disappears until he gets the vaccine again. Patient stated it seems like circulation issue. Patient get the same reaction every time he received the vaccine. Patient stated last night he felt a pinching feeling to where the markings were and then it goes away, any pressure that happens on his legs it causes that issue to arise. Patient emphasizes that it was like long indentations on his skin. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Initial report received from a consumer's parent on 13 October 2010. A 35 or 36-year-old female patient (both ages reported) with a history of epilepsy, received on 06 October 2010 a left arm intramuscular (IM) injection of ADACEL, sanofi pasteur Inc. lot number U3281AA and sanofi pasteur ltd. lot number C3354. The patient's mother reported that on the evening of 06 October 2010 the patient had a swollen area the size of a quarter at the injection site. On 07 October 2010, the patient developed giant hives and was seen in the Emergency Room (ER) where she was treated with intravenous (IV) steroids and given steroids to take at home. On 09 October 2010, the patient developed again giant hives and went back to the ER where she was treated with IV steroids and given more steroids to take at home. The outcome was reported as unknown. No available contact information was provided. Documents held by sender: None.
Case number PHEH2011US06695 is an initial spontaneous report received from a health care professional on 29 Sep 2011: This report refers to an adult female. She was vaccinated with MENVEO (batch number: M10061 and expiry date: Sep 2012) intramuscularly and with Varicella vaccine (batch number and manufacturer: unknown) into the same arm on 12 Sep 2011. After vaccination the arm that had received the injections had swollen up to three inches larger in circumference than the other arm. This was her second dose of MENVEO, first dose was given on an unspecified date but she did not experience any reaction after the first dose. No further information was reported.
pt recvd vax 28SEP95 & @ 8PM t104 & face began to swell;taken to ER; WBC & Ketones in urine
sore arm; extreme cold; body aches; extreme fatigue; This is a spontaneous report from a contactable consumer (parent). A 22-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unspecified route of administration on 21Jan2021 09:30 (lot number and expiry date unknown) at single dose for Covid-19 immunization in a workplace clinic. Medical history included Covid-19. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks. On 21Jan2021 09:30, the patient experienced sore arm and still has sore arm 3 days later, extreme cold and body aches (within 12 hour window), extreme fatigue that lasted 2 days. The patient was not Covid tested post vaccination. The outcome of the events sore arm, extreme cold, body aches, extreme fatigue was recovered in Jan2021.  Follow-up activities are possible, information on the batch number has been requested.
This spontaneous report was received from a pharmacist refers to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX vial, (lot #, expiry date, dose, frequency and route of administration not reported). During administration of ZOSTAVAX, the needle did not go all the way into the patient's skin therefore a bubble appeared under the skin but then slowly went away. Reporter asked if ZOSTAVAX has to be re-administered because patient's skin "bubbled up" after receiving ZOSTAVAX. Pharmacist reported that none of the dose leaked from the injection site for this unspecified patient. The outcome of "bubbled up skin" was recovered (slowly went away). Causality assessment was not provided. No product quality complaint (PQC) was involved. No further information provided regarding this unspecified patient. This is one of two reports received from the same reporter. Additional information has been requested.
started to sweat a lot; felt week; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (started to sweat a lot) and ASTHENIA (felt week) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (started to sweat a lot) and ASTHENIA (felt week). At the time of the report, HYPERHIDROSIS (started to sweat a lot) and ASTHENIA (felt week) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: high (High) increase.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications are provided. treatment to the events not reported.   Reporter did not allow further contact
"body feels hot", elevated HR, tingling in hand and arms. Evaluated by EMS-Cleared
Tingling  of lips and throat. Received treatment with dexamethasone, benadryl
Vaccine Kinrix is to be given from ages 4-6 yrs old. Vaccine was given at 1 yr 7 months. There were no adverse reaction to vaccine.
2 days p/DTaP/OPV vax pt exp t104 & neck pain, & irritability; lasted 5-6 days, complete recovery; inject site reaction also seen, but resolved sooner;
red spot; hot spot; This case was reported by a consumer via interactive digital media and described the occurrence of localized erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced localized erythema and feeling hot. On an unknown date, the outcome of the localized erythema and feeling hot were recovered/resolved.   It was unknown if the reporter considered the localized erythema and feeling hot to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient never had chicken pox and his/her sisters and children had them. The patient did not think that he/she needed the Shingles shot but physician gave it and had the reaction of big red hot spot. It lasted about 3 days and was scared that it was shingles but it was not. The follow up would not be possible as no contact details were available.
19 days p/vax pt devel a burning, itching rash on lt arm, dorsum wrist & shoulder;also devel scattered vesicles on lt lateral chest wall in a T4-6 dermatome distribution;seen by MD & recovered;this is 1 of 2 pt to devel rash p/vax
Patient developed a left seventh nerve palsy. Patient received vaccine in the morning and starting feeling weakness in facial muscles by that afternoon.
AFTER RECEIVING VACCINE, EMPLOYEE BECAME DIZZY AFTER WALKING A FEW MINUTES. REMAINED DIZZY FOR A DURATION OF 30 MINUTES. EMPLOYEE MONITORED AND GIVEN WATER TO DRINK.
Contracted COVID-19.; Contracted COVID-19.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 28 year-old male patient received bnt162b2 (BNT162B2), administration date 13May2021 (Lot number: EW0167) as dose 2, single and administration date 22Apr2021 (Lot number: EW0175) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 18Jan2022, outcome "unknown" and all described as "Contracted COVID-19.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Jan2022) positive, notes: Nasal Swab.  Clinical Course : Patient did not received other vaccine with in four weeks of covid vaccine. Patient did not have covid prior to vaccination.
Information has been received from a physician concerning a 40 year-old patient, who, on an unspecified date (when the patient was a child), received one dose of VARIVAX (Merck). It was reported that the patient had low titer when it was drawn recently (date not specified). At the time of the report, the outcome for low titer was unknown. Relatedness for low titer was not reported for VARIVAX (Merck). Additional information has been requested.
Initial unsolicited report received from a physician via other company, Pfizer (Reference number- 2017052032) on 22-Feb-2017. This case involves a male patient (age was not reported) who was vaccinated with TETANUS TOXOID (lot number, expiration date, route of administration, site of administration, dose and dose in series were not reported) on an unspecified day. The medical history and the concomitant medications were not reported. On an unknown day, following the vaccination, the patient developed allergy to tetanus. The laboratory test and the corrective treatment was not reported. The outcome of the event was unknown. List of the documents held by sender: none.