chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tender and sore around injection site then circular rash developed around injection site which migrated to inner arm. Also rash on chect, back, neck and ribs.
For 48 hours following vax, the infant had episodes about every 3 hours of having respiration's in which she would appear panicked, breath audibly and have retractions. She would then become more upset and start to cry and would fall asleep with exhaustion. Her breathing would then become normal. By 5:00 am on the following morning she had no further episodes.
pfizer first dose and moderna second dose; This spontaneous case was reported by a medical assistant and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (pfizer first dose and moderna second dose) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Pfizer (Dose 1) on 05-May-2021. Past adverse reactions to the above products included No adverse event with Pfizer. Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 26-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (pfizer first dose and moderna second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (pfizer first dose and moderna second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were provided.   This case was linked to MOD-2022-560565 (Patient Link).
Callwer had vacccine yesterday and this morning at 8:00 AM she started to vomit. She denies any fever, Shortness of breath, chest pain, rash, or any other symptoms. RN stated if she vomits again this morning to call her provider. Set for follow up tomorrow.
24MAR93 parents state pt's lt arm from elbow up to shoulder has redness & swelling; head start preschool teacher states there is an area of bright redness the size of a baseball @ lt deltoid area that is warm to touch;
Pt was being seen at clinic for a LAC on his scalp and was given a TDAP shot. The Lt arm was slightly painful after getting the shot, which patient figured was normal, the Sunday night he noticed that when he extended his arm there was pain in the lt arm where he got the shot, the pain has gotten worse since. He does have a hx of getting tetanus shots in the past w/no reaction.
Flu vaccine 29Sep2023; Flu vaccine 29Sep2023; Arm soreness; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 32-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 at 10:30 as dose 1, single (Lot number: HH7595) at the age of 32 years intramuscular, in right arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 29Sep2023 as dose 1, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 29Sep2023, outcome "recovering", described as "Arm soreness"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 29Sep2023, outcome "unknown" and all described as "Flu vaccine 29Sep2023". Therapeutic measures were not taken as a result of pain in extremity. Additional information: No covid prior vaccination and has not been tested for COVID post vaccination.
8/16/11: presented with 3in x 1in red raised warm lesion over site of PCV 13 (RVL upper), afebrile, rec warm compresses and call if worsened.
04/01/2021 around 5:00 PM:  1. Sore Arm, Shortness of Breath, Chest Pains, Fatigue. | Thought was Heartburn, took tums and had a little relief 04/02 to 04/05/2021: Same Symptoms throughout those day, had No appetite, increased fatigue. and Tums No longer gave relief. 04/06/2021 6:00 AM: Went to emergency room and had to receive emergency heart surgery as I was diagnosed with blood clogged arteries and had been having a heart attack for the past several days
Information regarding Dryvax was received from a healthcare professional regarding a male patient who experienced chills. The patient received a dose in 2003. Relevant medical history was not provided. Indication for Dryvax was immunization. Product was administered in 2003. Dose regimen was 1 dose 1 time per day (IM). Additional suspect medication included Anthrax Vaccine. Concomitant medications were not reported. The patient experienced chills (rigors). No additional information was available at the time of this report.
pt mom reports prolonged high-pitched crying >3hr induration p/vax;mom reports inc temp of 102-103;mom phoned ER & was advised to watch for inc fever & sz;mom reports crying lasted all day;
Sore arm, terrible headache, fatigue and generally not feeling well - like I was about to get the flu
pt recvd vax & 9 months later was found to have elevated liver enzymes;pt subsequently had a liver biopsy which was dx as liver cell induction
Pt recv vax on 3/25/99; 15 min post vax pt exp light headedness, itching arm, raised/ hot vax site, hot flashes, arm joints achy &sore; tx=Tylenol, Benadryl
Initial information received on 24-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves 11 number of elderly patient who was vaccinated with a dose of FLUZONE HIGH DOSE; lot UJ024AC and expiry date: 29-Apr-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 incorrect product storage. At this time no known reported symptoms from any patient. 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 and Module VI of the 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. List of documents held by sender: none.
SWOLLEN ARM /NECK/FACE/MUSCLE CRAMPS   - PT WENT TO ER DR SAID HE IS HAVING AN ALLERGIC REACTION TO HIS PFIZER VACCINATION ACCORDING TO PT
Client reported feeling anxious w/ elevated heart rate. She reported that it felt like a panic attack, Client was provided with water and powerade. PHN remained w/ client and talked to her until she reported feeling better. Vital signs taken again and stable. Client dismissed to home. VSS x 2 Pulse was 78 and 75 respectively.
A patient of unknown age and gender recently received Tice BCG (dosage and dates unknown) for treatment of bladder cancer.  Approximately May 2002, the patient had a recurrence of the bladder cancer.  The treating physician is very familiar with correct procedures and expected outcome.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 31-DEC-2015, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the long term prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. On or about 16-SEP-2016, the patient was treated for the onset of varicella pneumonia which is caused by the varicella zoster virus. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Upon internal review, varicella pneumonia was determined to be medically significant. Additional information has been requested.
only given the liquid portion of Menveo; only given the liquid portion of Menveo; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA466A, expiry date 31st March 2022) for prophylaxis.   On 18th November 2021, the patient received Menveo. On 18th November 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient received only the liquid portion of Menveo vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter stated that, a correct reconstituted Menveo vaccines was given on the day of reporting. The reporter consented to follow up.
Heat/cold intolerance , shivering , SOB Pt was taken away by Ambulance Pt came in on 9/3 to p/u meds and reported that she had a Heart Attack
This spontaneous report was received from an office manager concerning an unknown number of patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with doses of VAQTA, (lot # M003011, expiration date: 15-NOV-2017) (lot # M021124, expiration date: 02-FEB-2018) for prophylaxis (dose number, route and anatomical location of administration were not reported). The doses were stored between 32 to 35 Fahrenheit degrees for 120 hours, and 31 Fahrenheit degrees for 216 hours. There was no previous temperature excursion nor data logger involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA004193: US-009507513-1705USA004190: US-009507513-1705USA004191: US-009507513-1705USA004192: US-009507513-1705USA004194.
This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 8-year-old female patient who received INFANRIX (batch number AC7AG, expiry date 17th October 2016) for prophylaxis. Concomitant products included loratadine and melatonin. On 14th May 2015, the patient received INFANRIX. On 14th May 2015, unknown after receiving INFANRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, less than a month after receiving INFANRIX, the patient experienced injection site swelling, injection site erythema, injection site streaking, rash lips, tongue pigmentation, rash and skin discoloration. The patient was treated with BENADRYL and PEPCID. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site streaking, rash lips, tongue pigmentation, rash and skin discoloration were recovered/resolved and the outcome of the inappropriate age at vaccine administration was unknown. The reporter considered the injection site swelling, injection site erythema, injection site streaking, rash lips, tongue pigmentation, rash and skin discoloration to be related to INFANRIX. Additional information was reported as follows: This case was previously reported to the physician. This case was reported by the mother of the patient. The patient received a dose of INFANRIX and experienced swelling, redness at injection site with a white streak through it. Caller reported that the patient also experienced purple spots on face, lips and tongue. Caller reported that she took the patient to emergency room for treatment was not admitted and gave the patient BENADRYL and PEPCID which helped. Caller reported that the events resolved about a month after the dose was administered. The vaccine administration facility information was not obtained during phone consultation. This case is linked with case US2018115051, which was reported for different suspect product.
fever 101 degrees, headache, severe joint pain and body aches, nasua, stomach pain, shivering, weakness and tired, sore and swollen at injection site unable to perform daily functions for approximately 48 hours, lesser symptoms lingered for 72 hours no treatment just complete bed rest for 36 hours
NAUSEA, AND VOMITING. REDNESS, ITCHING AT SITE OF ZOSTAVAX IMMUNIZATION. LEG CRAMPS, AND WEAKNESS.
Headache, sinus headache symptoms, hot and cold chills, fatigue, hives next day  Recovered 24 hrs
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.             No treatment information was provided.  The vaccine was manufactured on 09 Mar 2021. Delivered at vaccination center on 30 Sep 2021. Patient did not experienced adverse event and there was no product quality issues.
Covid booster; Skipped a dose; not feeling good; weird feeling; headachy; something pulsing through body after Covid booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). Other Case identifier(s): 2021US005225 (Radius).  A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) (Batch/Lot number: unknown) as dose number unknown (booster), single for COVID-19 immunisation; Abaloparatide (TYMLOS), subcutaneous since 29Oct2021 (ongoing) (Batch/Lot number: unknown) at 80 ug daily for senile osteoporosis. The patient relevant medical history was not reported. Concomitant medication(s) included: CHLORTHALIDONE; LORAZEPAM; METHYLPREDNISOLONE [METHYLPREDNISOLONE SODIUM SUCCINATE]; VITAMIN D NOS. Vaccination history included: COVID-19 vaccine (Dose number unknown, Unknown Manufacturer), for COVID-19 Immunization.  The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Covid booster"; PRODUCT DOSE OMISSION ISSUE (non-serious), outcome "unknown", described as "Skipped a dose"; MALAISE (non-serious), outcome "unknown", described as "not feeling good"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "weird feeling"; HEADACHE (non-serious), outcome "unknown", described as "headachy"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "something pulsing through body after Covid booster".  Follow-up attempts are completed. The lot number for BNT162B2 was not provided and will be requested during follow up.
10 month old infant received Pfizer 12+ COVID vaccine instead of 6m-4 year COVID vaccine.
This spontaneous report as received from a nurse refers to a patient of unknown age. On 21-JUN-2013, the patient was vaccinated with GARDASIL, .5 ml, intramuscular (lot number 1397AA, expiry date 09-APR-2013) for prophylaxis. On 21-JUN-2013, the patient received an expired dose of GARDASIL. The outcome of received expired dose is unknown. The reporter considered received expired dose to be not related to GARDASIL. Additional information has been requested.
Unable to walk for 2 days, grapefruit size swelling and red/purple color skin at shot site location, fever 104, not eating, pain, muscle weakness, took to facility 3/06/2011 at 11:00 AM and got Bactrim antibiotic for tissue infection and was able to walk a little better that night starting at 5:00 PM and redness is light pink now 3/07/2011 at 9:00 AM and eating and fever is down, still soreness in the leg.
RECEIVED IMMUNIZATION 1 SHOT OF 3 YESTERDAY.  WITH IN 8 HOURS SITE OF INJECTION BECAME EXTREMELY SORE AND PAINFUL, COMPLETE RIGHT ARM WAS INVOLVED AND COULD NOT BE MOVED WITHOUT SEVERE PAIN.  I HAVE NEVER FELT PAIN LIKE THIS.  SLEEP WAS IMPOSSIBLE AND WIFE SAID THAT A SEIZURE HAPPENED, WHILE I WAS SLEEPING, WHICH SHE WOKE ME FROM AND FROM THAT POINT AROUND 2200 HRS - 2300 HRS THIS DATE, HAD SEVERE PAIN AND HAD TO SUPPORT ONE ARM WITH THE OTHER.  ALL MOVEMENT CAUSED SEVERE PAIN.  SITE OF INJECTION WAS NOT THAT RED.
swelling, petechiae, purpuric, erythema of hands/feet, hypersensitivity vasculitis.
Extreme sudden pain in right testicle. Went to ER for ultrasound to rule out torsion. Blood flow was normal. Pain dissipated after 11 hours. No other cause found.   Also soreness at the injection site surpassing what he had for the original doses.
Initial report received from a consumer who is the patient's parent on 05 June 2013. A consumer reported that her 7 year old son who had medical history of Autism that was diagnosed in 2006 at age 2 years had received a 5th intramuscular right deltoid injection of either Tdap or Dtap vaccine on 18 July 2012. The following day after vaccination, the patient developed a local reaction of redness and swelling at the site and was evaluated by a physician the following day. He was prescribed corrective treatment with BENADRYL and ibuprofen. Four weeks later, the patient developed stiffness and contortion of the right hand that progressed to all 4 extremities and by September 2012 he was unable to walk. The patient was hospitalized (dates not reported) for 4 days for testing to rule out seizures. Blood work, an MRI and EEG were all normal. A spinal MRI was also performed in November 2012 (results not reported). Neurology evaluation diagnosed dystonia and the patient was treated with dopamine and muscle relaxants. No specific cause has been determined. The patient had been up to date on all immunizations by 2 years of age, but vaccination was ceased after he was diagnosed with Autism 2006. At the time of this report, the patient had not recovered. Documents held by sender: None.
PT VACCINATED WITH MODERNA ON 1/21/21 (LOT 039K20A) + 2/22/21 (LOT 015M20A). TESTED + 9/2/21
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 58 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 15-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular, Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 15-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patient's will be contacted for revaccination.
This patient presented to the Medical Center ED on 10/8/21, ultimately with concern for Guillain-Barré syndrome. The patient reported his symptoms started on 10/5/21. He is currently being treated in the medical center for Guillain-Barré syndrome.  At this time, neurology is consulted and following the patient who is receiving IVIG x 5 days. Neurology has ordered several labs to rule-out other causes for this patient's acute presentation.
All regular side effects on day 1 + day 2. (Fever, chills, bone and muscle aches, headache). Shortness of breath started the next day on Sunday , extreme, far beyond normal asthma or any asthma attack. Went to urgent care on Tuesday- they said it was likely a side effect of j &J and tested me for COVID, kidney disease other things, all came back negtative. Apparently I wasn?t the first person they had seen with shortness of breath. Blood in cough and spit on Wednesday after 2.5 days of  shortness of breath. Dizziness (extreme) throughout and chest pain, sternum hurt, chest tightness. Went to Er. They ran a lot of tests and they too said they had seen others with shortness of breath from j and j. They ruled out many things like pneumonia, a birth control blood clot, any lung diseases with X-rays and blood tests. I was given torkeril to ease the chest pain and tightness which it did. Blood stopped coming up in tissues. Doctor said likely inflammatory reaction to the vaccine in lungs, (I have a piece of paper proving that) and cartilage and sternum., which hurt extremely when he touched it. Blood was likely from burst capillaries from overcompensation from trying to breathe. Recommended I return if more blood came up, which it hasn?t.  Shortness of breath has not subsided. I can?t even hold a phone app without being winded. So email back, don?t call.
5/25/00 left arm red warm swollen on deltoid down to mid arm, mom says child had fever 103 on 5/22/00 and was much more swollen down to elbow, improving now.
Patient told the monitoring nurse he is going to pass out; monitoring nurse stayed with patient and called paramedics for help; while waiting for paramedics patient passed out in the nurse?s arms; patient did not hit the ground; patient woke up after 30 seconds; paramedics arrived in two minutes; patient was offered Gatorade; patient rested and was not transported.
Fever, chills, loss of appetite, fatigue, flu-like symptoms, dizzy (almost pasted out) starting 18 hours after receiving vaccine until 48 hours after vaccine received.
Fever 100.3, local rxn rt thigh; coma or marked alteration in LOC, cannot be fully aroused; hypnotic, hyporesponsive episode;
a week after I got Covid arm. Exactly a month after I had severe pain at the bottom of my right shoulder that progressively got worse throughout the day. I took anti-inflammatories and pain killers over 12 hours it just got worse. Then I took aspirin, I blacked out from pain. When I woke pain was gone.
I woke up Wednesday morning very dizzy & with abdominal pain. I started vomiting later in the day, went to the hospital, and ended up having appendicitis. I got my appendix removed on Thursday. One doctor suggested that since people usually get appendicitis after being sick, they might be related.
Information has been received from a registered nurse concerning a patient who on 19-JUN-2012 was inadvertently administered with a dose of ROTATEQ (dose and route not reported) (lot number 1463AA - in validation, Exp: 30-JUN-2013). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.