chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm after both shots; Tired; Couldn't stop shaking; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm after both shots), TREMOR (Couldn't stop shaking) and FATIGUE (Tired) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced TREMOR (Couldn't stop shaking). On 20-Feb-2021, the patient experienced FATIGUE (Tired). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm after both shots). On 20-Feb-2021, TREMOR (Couldn't stop shaking) had resolved. On 22-Feb-2021, FATIGUE (Tired) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm after both shots) outcome was unknown. Unknown          Concomitant product use was not provided by the reporter. Treatment medication use was not provided by the reporter.
Covid positive no prior history after full vaccination. Positive test 7.12 2021. PMH of covid 11.23.2020.
About 15 minutes after receiving the Pfizer vaccine patient experienced a strange taste in her mouth, dizziness and nausea. Patient is still experiencing episodes of drops in her blood pressure and syncope. Patient advised not to get the second Pfizer vaccine but to get the J&J instead. Pt agreeable to this.
This is a spontaneous report from a contactable consumer (mother of the patient) with follow-up from the same consumer (listed as other health care professional on follow-up). This is the first report of two reports from this same reporter. A 2-month-old male patient (son of reporter) received the first dose of PREVNAR in the left leg on 05Aug2011 for the prevention of pneumonia. There was no relevant medical history. Relevant concomitant medication included a dose of PENTACEL administered in right leg on 05Aug2011. According to the mother, the right leg did not hurt and the patient did not really cry after injection. On 05Aug2011 the patient experienced uncontrollable screaming and crying due to excessive pain (reported like a seizure) for almost 15 minutes after injection of PREVNAR in left leg. Outcome was unknown. Follow up (09Aug2011): New information reported from the same contactable consumer (listed as other health care professional on follow-up) includes: patient demographics, change in product from PREVNAR 13 to PREVNAR, product details, concomitant medication, medical history and course of event details.
Child complained of dizziness approx two minutes after giving immunizations. Child's grandmother stated child had not eaten since breakfast. Sugar drink was provided and child ate fruit and chips. Child sat in chair for approx 30 min and she stated the dizziness was gone.
Sore arm; Slight chills; Low energy; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the right arm on 22Apr2021 at 19:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as thyroid cancer survivor. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included levothyroxine sodium (SYNTHROID 88), cetirizine hydrochloride (ZYRTEC), paracetamol (TYLENOL ES), multivitamin (MANUFACTURER UNKNOWN) and vi (MANUFACTURER UNKNOWN), all for unknown indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the right arm on 01Apr2021 at 19:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021 at 09:30, the patient experienced sore arm, slight chills and low energy. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events sore arm, slight chills and low energy was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
A non-serious spontaneous report of administration of one-half dose of expired product was received from a certified medical assistant concerning a 15-year-old male subsequent to FLUMIST. Neither medical history nor concomitant medications were reported. On 30-Dec-2008, the reporter administered one-half of FLUMIST dosage when she noticed that the product had expiration date of 26-Dec-2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 20-Mar-2009: Investigation lot analysis results. Follow-up information was received on 04-May-2009: confirmation that the patient did not experience any adverse events.
Pale, collapse, BP 80/65, p60, 2min p/vax;
A few days after, he, my husband, rec'd the flu shot, he had side effects - like flu symptoms, which at time, is normal. However, the effects from the shot went on for 2 wks. and gotten worse - with headache, diarrhea. Went to ER 2x.
Left arm pain and swelling at injection site (immediate, lasting 7 days) Fatigue, aches (whole body), chills, headaches, (starting 5 hours later, lasting 8 days) Sore throat and some nasal congestion (48 hours later, lasting 6 days) Low fever 99.5 - 100.7 (96 hrs later, lasting 4 days)
14 year old female presents to out clinic for well child check on 4/16/01. Pt received 4 vaccines. Pt returned to clinic on 4/18/01 with pain and swelling of left deltoid and was dx'd with cellulitis and treated with Keflex. Symptoms are improving.
This case was reported by a consumer and described the occurrence of seizure in a female patient who received BOOSTRIX (batch number 2E9JG, expiry date 8th October 2017). On 5th December 2015, the patient received BOOSTRIX. In December 2015, 3 days after receiving BOOSTRIX, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure was unknown. It was unknown if the reporter considered the seizure to be related to BOOSTRIX. Additional details were received as follows: This case was reported by a pharmacy via a pharmacy claims management company. In December 2015, 3 days after receiving BOOSTRIX, the patient experienced 2 known seizures.
1445 shots given child crying, mom at side. 1450 child did not feel well, laid back on exam table. 1455 child responded inappropriately to questions vital signs pulse 64  blood pressure  116/74. 1505 child still not responding appropriately to questions vital signs pulse 68 blood pressure 118/64 O2 Sat 99% 1510 EMS notified, mom told child if she did not feel well or felt queasy from the shots she needed to get up so they can go home and not trouble all these people, child was lying down with her head elevated 45 degrees, open her eyes and looked at her mom O2 sat 98%. 1520 EMS arrived child closed her eyes and than opened them in response to her name being called. 1530 EMS transported child to local hospital.
Fatigue and headaches 12/14/2020 about 12pm , Caller took Tylenol and advil with no relief and next day pain had subsided.
Received immunizations @ 9AM - broke out in rash starting @ 12 N 1 place under eye (looked like blister- went away- 2 under neck @ 1:30 they went away then @ 4PM started getting them all over arms, face legs.
Injection site red, swollen painful.  Redness 3 in diameter, itching at site day 2, redness increased, swelling unchanged.
Facility filled out consent form stating that the resident has not been vaccinated before.  Later the facility contacted the pharmacy stating resident has actually completed the series of Moderna previously.  Given this information the resident should not have been vaccinated again.  At this time no adverse events have been reported.
Red rash, rectal area and hairline. progressed to arms and body. Developed hives TC to MD given prescription for methylprednisolone PO.
persistent increased heart rate at rest. (90 bpm); This is a spontaneous report received from a contactable consumer (patient). A 14-years-old male patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot number: unknown), via an unknown route of administration on an unknown date as dose 1, single and second dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine , solution for injection, batch/lot number: unknown), via an unknown route of administration in right arm on an unknown date as dose 2, single for COVID-19 immunisation at public health clinic/veterans administration facility. The patient's medical history was not reported. Concomitant medications included sertraline hydrochloride (ZOLOFT) and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); both were taken foran unknown indication from an unknown date and take multivitamin. No other vaccine in four weeks. On 28May2021, the patient persistent increased heart rate at rest. (90 bpm); identified as "not looking well" at school and sent home resolved over time. did not seek additional medical support beyond school nurse. Event resulted in doctor or other healthcare professional office/clinic visit. No covid prior vaccination and no covid tested post vaccination. No treatment received. The outcome of the events was recovered on an unspecified date in 2021.  Information on the lot/batch number has been requested.
This is a spontaneous report from a non clinical study program (IBCC (Inbound Call Center for HCP's) for a contactable pharmacist. A 73-year-old male patient of unspecified ethnicity received PREVNAR13 (Lot # J49843), via an unspecified route of administration, on 19DEC2014, at single dose. Relevant medical history included arthritis in spine. Concomitant medications were not reported. On an unspecified date after the vaccination the patient noticed arthritis in his shoulder and other areas. Outcome of the reported event was unknown at the time of this report. The pharmacist said that she was not sure if arthritis in the patient's shoulder and  other areas was due to PREVNAR13. NDC#00005197102. Follow-up (06MAR2015): Follow-up attempts completed. No further information expected.
Blood pressure rose to 160/100. Checked it several times. My normal blood pressure is around 120/80. Then, while cooking, my blood pressure dropped, dizzy. I sat down. checked BP at 111/68.  Then 30 minutes later it was back to 158/102. I was fine the next morning, BP 120/79
This spontaneous report was received from a registered nurse concerning a currently 3 months old  patient with unspecified gender. The patient's pertinent medical history, concomitant medication and drug allergies/reactions were not provided. On an unspecified date, the patient was vaccinated with an improperly stored doses of LIQUID PEDVAXHIB (incorrect product storage) lot# M047666, expiration date: 24-OCT-2019 for prophylaxis (dose, frequency, route of administration were not reported). The administered dose of the vaccine experienced a temperature excursion 32 degree Fahrenheit to 35 degree Fahrenheit for 6 hours. There were no adverse effects reported. There was no previous temperature excursion. Data logger was involved. The outcome were unknown. No product quality complaint was involved. This is one of several reports received from the same reporter.
Vaccine administered 12/2/22 at 1338. LVN reported No adverse reactions at 1438. LVN entry for  2125 indicates oxygen saturation of 60 on 2L by nasal cannula, cyanotic lips and labored respirations, s/s of respiratory distress noted, secretions from mouth, suctioned. Oxygen increased to 5L. Saturations to 96%. After suctioned, decreased oxygen to 2L (normal for her) and she remained stable. Dr ordered ECG and it had abnormality so pt. was transferred to the hospital.
Information has been received from a medical assistant concerning a male patient who was vaccinated with a dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (Lot # 654998/0827F).  On an unspecified date the patient developed a rash (site unspecified).  The patient sough unspecified medical attention.  At the time of the report the patient's status was unknown.  A product quality complaint was not involved.  Follow-up information was received on 20-SEP-2007 via a telephone call.  Medical assistant confirmed that a male patient developed a rash following vaccination.  This is one of several reports from the same source.  Additional information has been requested.
1-2 hours post vax, the pt again experienced arthralgia of the left shoulder, hip, knee, and ankle. He was treated with NSAIDS. The pt experienced complete resolution of symptoms after two months.
Received swelling and high temperatures around area of shot 10 days in the morning after injection, had also experienced side effects such as high temperature, fatigue, and sneezing as well
Body ache, sharp joint pain, headache, nausea, vomiting, diarrea, chills.
sore and achy arm; A spontaneous report was received from a Healthcare Professional concerning a 77-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore and achy arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 28 Jan 2021, prior to the onset of the event the patient received their second of two planned doses of mRNA-1273 (lot: unknown) via unknown route for prophylaxis of COVID-19 infection.  On 28 Jan 2021, the patient experienced sore and achy arm.   No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not applicable.   The outcome of event, sore and achy arm was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Neuritis of left shoulder/brachial plexus nerve irritation possibly related to injection of IPV Lot No: R0100-2 or Hep A Lot #1758K.
W/in 24 hrs p/immun, infant experienced a fever of 105. Fever lasted for one day. Recovered.
felt weak; chills; muscles hurt all over; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (felt weak), CHILLS (chills) and MYALGIA (muscles hurt all over) in a 74-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 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced ASTHENIA (felt weak), CHILLS (chills) and MYALGIA (muscles hurt all over). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. On 11-Mar-2021, ASTHENIA (felt weak), CHILLS (chills) and MYALGIA (muscles hurt all over) had resolved.            No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Updated contact information
Severe redness down her arm; This case was reported by a physician via sales rep and described the occurrence of erythema of extremities in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced erythema of extremities. On an unknown date, the outcome of the erythema of extremities was recovered/resolved.   It was unknown if the reporter considered the erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After vaccination with dose of Shingrix, the patient had severe redness down her arm that lasted for a week. The reporter did not consent to follow up.
Numbness, tingling and slight swelling in the right side of the face from the ear and cheek down to the jaw and mouth
A 77-year-old female was referred for evaluation of chronic diarrhea. The patient stated she has been having diarrhea for the last 2½ to 3 months (since early July). It has been happening on average once a day, but there are times when it was up to 3 times a day. It has mostly happened shortly after eating. It is usually of pasty or "cream of wheat-like" consistency. She denied seeing blood or having change in the color of stools. She also described having abdominal bloating after eating (less frequent but associated pattern started after the diarrhea started). However, she had that sometimes in the past too. She denied having abdominal pain, nausea, vomiting, constipation, melena, blood in stools or significant weight loss. She has been fluctuating up and down within a range of about 4-5 pounds. She had an EGD and colonoscopy back in January 2013 (almost 9 years ago) that revealed some distal esophagitis but normal colonoscopy. She planned for her next screening colonoscopy 10 years after the last one in 2013 (January 2023). She has strong family history of autoimmune disease per her statement (thyroid and others), in addition to some second degree relatives with IBD. She never had celiac screening. The patient was seen by her PCP around 2 months ago for routine check when the diarrhea issue raised. No work-up done yet. She was eferred to general surgery for further evaluation.
2017.10.09, 930 PM 100.4 temperature, chills and diarrhea. Took two 500 mg acetaminophen caplets and two 2 mg loperamide HCL tablets. 10:44 PM 100.9 temp, chills and severe diarrhea. 11:47 PM 101.4 temp, chills and diarrhea. 2017.10.10, 2:22 AM 100.4 temp, nausea with vomiting and diarrhea. Would have tried to take more for fever, but couldn't possibly keep anything down. 12:56 PM 100.3 temp and body aches. Mostly diarrhea, chills and nausea had subsided. 1:20 PM took two more 500 mg acetaminophen caplets for remaining temp and body aches. 9:04 PM 98.4 temp with fatigue and body aches. 2017.10.11, spent the majority of the day in bed sleeping and resting. 2017.10.12, back up and about.
Information has been received from a registered nurse concerning a 9 year old patient with seasonal allergies who on 30-JAN-1999 was vaccinated SC on right thigh with a first dose of varicella virus vaccine live (Oka/Merck) (Lot # 628694/1663H). Concomitant therapy included a SC first dose on left thigh with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) (Lot # 628901/1547H). At the time of vaccination, the patient did not have any illness. It was reported that on 04-MAY-2007 the patient developed less than 50 lesions for 5 days. The patient did not experience any problems and not itching. On 08-MAY-2007, the patient recovered. No medical attention was sought and no diagnostic laboratory tests were undertaken. It was also noted that the patient did not have any adverse events following prior vaccination. No further information is expected. This is one of several reports received from the same source. It was also reported that the patient's sister had a similar experience after therapy with varicella virus vaccine live (Oka/Merck) (WAES # 0705USA03994).
Red blotches on arm and left side of face. Sites were sore and hot. Treatment was two shots (steroids) in dr office. This happened ten days after shot. This was the first shot.
Lymph nodes swelling especially in groin where it was large and painful and it erupted.  Breasts hurt this time and also during a prior booster.  It seems with each injection the lymph nodes swelling gets worse.
received a dose which expired; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 60-year-old female patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd June 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 22nd June 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-JUN-2022 Reporter's Comments: The pharmacist reported that inadvertently patient received a dose of Havrix which was already expired. Lot number was provided by the agent who initially took the pharmacist's call before the initial call was disconnected. The reporter consented to follow up. Additional Supportive Information: The use of Havrix dose which was already expired on 18th June 2022, which led to expired vaccine used.
The 3 vaccines were administered to patient on 10/12/2023 at 11:39 a.m.  She was instructed on common side effects and asked to remain in waiting area for 15 minutes.  Patient then left area with no issues.  That evening, she began feeling bad and saw the facility nurse the next morning for vomiting.  The nurse kept an eye non her until Saturday morning when she was sent to hospital and admitted to ICU.  She then died sometime between then and Monday morning.
Incorrect dose amount of Moderna 23/24 6m-11 given on 10/24/2023. Patient's ordered dose was 0.25mL but was given approximately between 0.4-0.5mL. Patient's mother expressed understanding. Instructions provided to monitor patient for additional or prolonged side effects with call back number for Nursing Supervisor. Additionally, a message sent to patient's PCP informing them of error. Father called to request a letter containing information about the administered dose in order to contact the CDC and ascertain whether any additional precautions are necessary.