chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Child had received the flu vaccine with mother in attendance at a parent teacher conference. They had left the room where shot was given and were in the hallway when child fainted and had jerky movements of extremities lasting 10-15 seconds. This nurse did not see child faint, but it was witnessed by another mother present for her child to get the flu vaccine. This witness happens to be a registered nurse and reported the jerky movements. Child awoke after 15 seconds and was able to say her name and where she was correctly. Child had scrape on forehead and was found lying with her head against a brick wall. Uncertain if she hit her head when she fell or if she turned to side during the jerky movements that were reported. Mother took child to the Hospital to have her checked. Phoned child's mother the next day and she reported that the doctor felt everything was ok, but did check with a neurologist to make sure. Child attended school the next day and mother reported child just had sensitivity to touch where she had a "goose egg" on her forehead.
Red, warm, raised area to direct injection site measuring 5.6 cm width by 4 cm height
Significant local reaction at injection site after 3rd injection of Anthrax. After 6th injection continued and increasing joint and muscle pain.
Medium pain and soreness in left arm at injection site immediately after, 30 min later heavy soreness in entire left arm down past elbow  -8 hours later moderate headache  - 1 hour after above splitting headache -  20 minutes later extreme chills chittering teeth and coldness  - then after 20 minutes heat feeling overtook body - splitting headache continues
Received vaccines at 11 am. At 11:20am complained of nausea,light headed and feeling hot. Patient reports took Lisinopril this AM. 11:23am B/P 140/100.  Gave Sprite. Complained of feeling weak and faint.  Place on floor,on back with feet in air. Places O2 at 4L per mask. Called Dr. Complained of throat feeling tight, EPI pen given in right thigh at 11:25am. Called EMS. Ambulance arrived at 11:30, B/P 150/100. Ambulance personnel checked Blood Sugar 88. Left on stretcher with ambulance at 11:35am. Patient was talking and able to give phone number of family member to call. Pt. did not leave with ambulance.
Headache; Fatigue; flushed face; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), FATIGUE (Fatigue) and FLUSHING (flushed face) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 18-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 HEADACHE (Headache), FATIGUE (Fatigue) and FLUSHING (flushed face). At the time of the report, HEADACHE (Headache), FATIGUE (Fatigue) and FLUSHING (flushed face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Patient presented to the ED and was subsequently hospitalized for tongue mass and facial swelling within 6 weeks of receiving COVID vaccination.
Pt. participated in a Astra Zenica Covid-19 vaccine trial on 11/30/2020. He was unblinded and did receive vaccine. He tested + for Covid on 12/19/2020 and was advised by his MD to get vaccinated.  He received first dose of Moderna on 01/29/2021. He returned for his 2nd dose on 02/26/2021 and it was not administered d/t discovery of participation in vaccine trial.
Swollen and tender axillary lymph node in left underarm (same side as injection). Resolved fully without treatment approximately 72 hours from onset of symptom.
Exclusively breastfed infant had increased fussiness and was inconsolable. Milk supply decreased as well.
Upper right arm and shoulder area feel weak, painful, keeps twitching, feels restless; Upper right arm and shoulder area feel weak, painful, keeps twitching, feels restless; Upper right arm and shoulder area feel weak, painful, keeps twitching, feels restless; Upper right arm and shoulder area feel weak, painful, keeps twitching, feels restless; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 02Feb2022 17:45 (Lot number: FJ5682) at the age of 40 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Major depressive disorder" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE SODIUM; PROZAC. Past drug history included: Meloxicam, reaction(s): "Allergy: Meloxicam", notes: Allergy: Meloxicam. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: 33025BD, Location of injection: Arm Right, Vaccine Administration Time: 05:45 PM), administration date: 12Jan2022, when the patient was 40 years old, for COVID-19 immunization. The following information was reported: MUSCULAR WEAKNESS (non-serious), PAIN IN EXTREMITY (non-serious), MUSCLE TWITCHING (non-serious), RESTLESSNESS (non-serious) all with onset 05Feb2022, outcome "not recovered" and all described as "Upper right arm and shoulder area feel weak, painful, keeps twitching, feels restless".  Additional information: The onset time of adverse event was 12:00 AM. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID prior to vaccination and had not been tested COVID post the vaccination. Other medications in two weeks: Levothyroxine, Prozac.  Follow-up attempts are completed. No further information is expected.
Patient developed a mild rash all over his body exactly 10 days after his MMR shot.
Raised red hives on l/shoulder extending across the back of shoulders and to the posterior neck.  Described as very painful.  No a true dermatoform distribution.  Started one week after flu shot (10/28/99).
At 1130 Vaccine administered IM to L deltoid. At 1136 Employee states that a burning sensation to left arm. At 1138 Employee states that itching began BP: 138/92 Pulse: 94. At 1145 Employee states that she was itching all over body. BP: 142/98 Pulse: 100. BENADRYL 50mg given PO. At 1155 BP: 140/90 Pulse: 88. At 1200 Employee began shaking, still complains of itching all over body. At 1210 Employee was driven to Clinic by another employee. Employee states that at Clinic she was monitored until stable and given a prescription for ZYRTEC and scheduled for a follow up appointment. Clinic physician recommended colloidal oatmeal bath treatment. Employee states that she currently has mild itching.
Itching at injection site started 6-7 days after injection on day 7 very red raised round itchy hot 6 cm wheal appeared and stayed for 24 hours then resolved in 1-2 more days with nothing more than ice. I am happy to share a photo in case useful.
redness, pain, heat, and swelling to injection site. Cellulitis diagnosed 14 days post vaccine administration
Suspected vaccination failure; still got shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles. The patient reported that, it was not 100 percent effective. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Information has been received from a nurse concerning a male on 26-APR-2007 who was vaccinated with Rotateq (LOT 656385/0030U) first dose and the second dose on 20-JUN-2007 (LOT # 656184/0558U). Concomitant therapy included PEDIARIX, PEDVAX HIB and PREVNAR given on 26-APR-2007 and 20-JUN-2007. The nurse reported that the child had presented to the office with foul smelling diarrhea with no fever. The nurse reported that they were testing the child for rotavirus. The nurse reported that the patient had not recovered. There was no product quality complaint. Additional information ha been requested.
Patient stated one week after first dose, sores appeared on upper portion of right arm. I saw about 4-5 scabs on right arm and one on left on date of second dose (2/24). She said they don't itch/bother her, but she was advised to consult physician since sores are still present.
After vaccine, patient developed persistent cough, shortness of breath, and fevers. Was diagnosed with COVID via POCT on 2/25/21 and was discharged from ED given lack of symptoms. Returned 2/27/21 after oxygen saturation found to be ~50% at home. Admitted for severe COVID infection requiring dexamethasone and remains inpatient.
No adverse event; Patient received the bivalent booster instead of completing the primary series(For the 2nd dose patient received the new Moderna bivalent booster); This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the bivalent booster instead of completing the primary series(For the 2nd dose patient received the new Moderna bivalent booster)) and NO ADVERSE EVENT (No adverse event) in a 27-year-old female patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 vaccination.     It was unknown, if the patient was ever had tested or diagnosed with COVID. It was unknown if the history was related to mentioned event and both Acute and Chronic illnesses at the time of vaccination. It was unknown whether other vaccines given within 1 month prior to Moderna COVID-19 vaccine (type, brand, lot, route, dose).     On 10-Sep-2022, the patient received second dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 10-Sep-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the bivalent booster instead of completing the primary series(For the 2nd dose patient received the new Moderna bivalent booster)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the bivalent booster instead of completing the primary series(For the 2nd dose patient received the new Moderna bivalent booster)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the bivalent booster instead of completing the primary series(For the 2nd dose patient received the new Moderna bivalent booster)).    It was reported that patient took 1st moderna dose 0.5 ml on 09Jan2022, Intramuscular (left arm) with lot number 066H21A with indication of COVID-19 vaccine. Patient received 1st booster Bivalent as 2nd dose. Reporter does not know if patient was taking other medication.  No concomitant medication was reported. No treatment medication was reported.
child received an expired dose of daptacel with no reported adverse event; Initial information received on 14-Oct-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 5 years old male patient who received an expired dose of diphtheria-15/tetanus/5 ac pertussis vaccine (Daptacel) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included polio vaccine inact (IPV).  On 13-Oct-2022, the patient had received a dose of 0.5 ml total (dose 4) of suspect diphtheria-15/tetanus/5 ac pertussis vaccine Suspension for injection standard (lot C5774CA, expiry date- 18-Sep-2022) via intramuscular route in the left deltoid for Immunization.  On 13-Oct-2022, the patient had received an expired dose of daptacel with no reported adverse event (expired product administered) latency same day following the administration of diphtheria-15/tetanus/5 ac pertussis vaccine.  No lab data was reported  Action taken - not applicable.  Outcome - Unknown   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 the guidelines. 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.
pt recv vax 24MAR98 okay until child took nap & when woke up @ 11400 had several red blotch like areas on stomach, lack, foot-head-described to look like ring worm w/an indentation into he center;MD was notified by mom;inc hives later 1130P
headache; little nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and NAUSEA (little nausea) in a 52-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 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced HEADACHE (headache) and NAUSEA (little nausea). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 19-Mar-2021, HEADACHE (headache) and NAUSEA (little nausea) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   This case was linked to MOD-2021-089710 (Patient Link).
This spontaneous report as received from a physician refers to a 18 year old female patient with no known allergies. The patient's medical history included syncope episodes. On 25-JUL-2014, the patient was vaccinated with the first 0.5 ml dose of GARDASIL (lot # J009788, exp 17-MAR-2016) intramuscularly in the left arm. There were no concomitant medications. The physician reported that on an unknown date in approximately July 2014 post vaccination, the patient experienced violent headaches and dizziness. The patient went for doctor visit on 30-JUL-2014 with complaints of violent headache, dizziness but no fever. The patient was sent for Nuclear magnetic resonance imaging (MRI) which showed normal results. The patient was sent to neurologist consult, the diagnosis was headaches with unknown etiology. The patient was treated with EXCEDRIN and MOTRIN. At the time of the report, the patient had not recovered. Headaches with unknown etiology was considered to be disabling and medically significant by the physician because the patient went to MRI and neurologist consult. Additional information has been requested.
Breakthrough COVID-19 case, Shortness of breath or difficulty breathing,  Fatigue or tiredness, loss of appetite, hospitalized at hospital and was admitted on 08/17/2021 for COVID-19 pneumonia
Information has been received from a registered nurse concerning a 6 year old male with no medical history allergies or drug reactions, who on 15-JUN-2004 was vaccinated with the first dose of VARIVAX (Merck) (Lot no. 648083/0072P) SC and with a dose of MMR (Lot no. 646906/0956N), SC (dose not reported).  On 18-APR-2008 the patient was vaccinated with the second dose of VARIVAX (Merck) (Lot no. 659941/1791U) SC and with a dose of MMR (Lot no. 659540/1745U), SC (dose not reported).  Other concomitant therapy included a dose of (Lot no. 495-212) PREVNAR and a dose of (B223AD) HAVRIX.  The nurse reported that on 14-MAR-2009 the patient developed many papules and a few vesicles on trunk, arms and legs.  It was reported that the patient experienced varicella.  The patient was prescribed TYLENOL and BENADRYL.  Subsequently, the patient recovered from varicella.  The patient sought medical attention by a doctor visit.  Additional information has been requested.
Did not receive 2nd dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 2nd September 2020, batch number zx27e, expiry date 16th September 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 07-SEP-2022 Reporter's Comments:  The pharmacist reported that the patient was late for the second dose of Shingrix.  No adverse event was reported. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of vaccine after 1st dose, which led to incomplete course of vaccination.
Administration Error:  During vaccination with the 1st dose of J&J vaccine,  an estimated 90% of the dose leaked out of the syringe hub due to a loose connection with the needle.  The provider counseled the patient and it was determined we could proceed to repeat the vaccination with a new/full dose.  No adverse events were identified in the immediate observation period.  We continue to educate our teams to check for a secure needle connection during our quality check between production and vaccination.
Information has been received from a physician concerning a patient who was vaccinated PO with the first, second and third doses of ROTATEQ.  Subsequently after the first dose the child experienced severe vomiting for 24 hours after administration.  Subsequently the patient recovered.  With the second dose, the child vomited a couple of times then recovered.  On 06-JUN-2007 the child was vomiting several times within 24 hours from administration (similar to the first dose).  The patient sought medical attention through a nurse (mother).  The child got better within 24-36 hours of the third dose.  There was no product quality complaint.  Additional information has been requested.
Started complaining about her leg not being able to run. No fever at this point, site of injection not swollen, feverish or hard but just little dots. She didn't eat lunch, started slowing down and was telling me she just couldn't run. She appeared a bit pale and bags around her eyes. Sat on my lap not wanting to do anything and couldn't get comfy enough to nap, we got tylenol. First dose went ok, she ate dinner and laughed. Then the 2nd does didn't relieve the fever she gained and she kept complaining of an upset tummy.
Vaso-vagal syncope after shot. Continued to feel unwell after 10 min monitoring time. Transported to hospital for further evaluation. Discharged after approximate 2 hours observation.
2nd shot site reaction (pain, redness) lasted 9 days. Rash on torso and upper arms, appeared 2 weeks later. Diagnosed (by dermatologist) as Grover's Disease. Might be a coincidence, but I thought I'd better report it.
Immunocompromise patient received lower authorized dose volume; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromise patient received lower authorized dose volume) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Immunocompromise patient received lower authorized dose volume). At the time of the report, ACCIDENTAL UNDERDOSE (Immunocompromise patient received lower authorized dose volume) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Pharmacist informed that the patient did not receive their primary series or booster dose of Moderna COVID-19 vaccine at their pharmacy.  No treatment medications were reported.   Reporter did not allow further contact
Case number PHEH2016US026202, is an initial spontaneous report received from a pharmacist on 07 Oct 2016. This report refers to a patient of unknown age and gender. Medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: not reported) at an unknown dose intramuscularly on 06 Oct 2016. The pharmacist stated that, after administration of FLUVIRIN dose, part of vaccine came back out of injection site. No adverse event was reported following this administration error (underdose). The pharmacist assessed the case as non serious. The case was lost to follow up at initial.
Inflamed, erythematous, no lymphangitic streaking ROCEPHIN 1 gm given 10/19/18, KEFLEX 500 mg one 2 x day - 10 days.
Myalgia, Arthralgia,  Fatigue Narrative: Took Tylenol
This is a spontaneous report from a contactable consumer. This consumer reported he/she received my PREVNAR13 adult vaccine the day before this report at the Health Center. On the day of this report he/she had pain in t he arm that was injected. The site of injection was the upper left arm. He/she received the injection at 1PM on 29JAN2013. He/she had not other symptoms at this time.
Developed Shingles rash on right upper back.  Itching, sharp intermittent pain, redness, sores.  Currently on 2/9/2018 Shingles are still present.  Diagnosis confirmed by family physician on 1/29/2018.
4/7/17: Pt. given varicella vaccine. 4/11/17 (R) arm swollen around vaccine site, denied pain. 4/14/17 (R) arm no swelling. Reported swelling post vaccine in camp. Vaccine unknown.
Bilateral swelling of hands & arms 15 min after shots hands red & blothy, appearance & swollen.  swelling started in hands that went up to shoulders.  TD site red, hot, swollen.  Left arm and had more swollen then right.  Saw Dr., dx. allergic reaction to TD, vascular spasms.  4/8/03- spoke with mother by the phone.  Child saw Dr.x2 yesterday, better today.  He is back in school.