chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ADACEL at 134.70F for 6 minutes due to a refrigerator malfunction with no reported adverse event; administered after the excursion, with no reported adverse event; Initial information was received on 04-Apr-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 10 years old female patient and diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] was unopened at 134.70 f for 6 minutes due to a refrigerator malfunction event and administered after the excursion 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 hepatitis b vaccine (Hepatitis B vaccine); influenza vaccine inact split 4V (Fluzone quadrivalent); and HPV vaccine (HPV vaccine) for prophylactic vaccination (immunisation).  On 18-Mar-2023 diphtheria-2/tetanus/5 AC pertussis vaccine was unopened at 134.70 f for 6 minutes due to a refrigerator malfunction with no reported adverse event (product storage error) (unknown latency) and On 28-Mar-2023, the patient received a dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine at dose of total (1x) 0.5 ml (lot number: U7549AA, expiry date: 04-Nov-2024, strength, formulation, administration site: Unknown) via intramuscular for Immunization (Immunisation) administered after the excursion, with no reported adverse event (poor quality product administered) (latency: same day)  No lab data reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events.  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 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. Cluster AE cases: 01562152, 01562191, 01562224, 01562233, 01562239 and 01562252
Left arm (injections site) is swollen. I have dull pain and at times itchy. Feels like a bee or wasp sting. A few days before I was sick and was chilled but did not associated it with the vaccine. Now, I'm not so sure given this showed up 2 days later.
Information has been received from a physician who cut her finger on a broken vial of MMR II (lot # 663667/0036Y).  The physician reported that it was not serious.  The physician reported that they had received a ten pack carton of MMR II, that had one crushed vial.  The physician stated that the vial was intact on the top, the flip off cap, metal crimp was intact.  It was only the bottom of the vial that was crushed.  It looked like there was a residue inside the vial, but the physician was not sure.  There were glass pieces inside the carton.  The physician cut her hand on the glass pieces.  The physician stated that there was no carton damage.  That vial was the last one in the carton, the first one from the left side, back row.  The physician stated that this had never happened before.  Product Quality Complaint was involved.  Follow-up information has been obtained from the physician stating that the vaccine was not administered to the patient and the vial was broken.  Follow-up information was received from the physician who had minor scratch.  Additional information is not expected.
pt recvd vax; pt devel redness & swelling at inject site;ice applied to rxn site & all sxs resolved w/o sequelae;
Shaky; Dizzy; Brain-Fogged; Lightheaded; Vomited; Tired; Body Pain; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaky), DIZZINESS (Dizzy), FEELING ABNORMAL (Brain-Fogged), DIZZINESS (Lightheaded) and MYALGIA (Body Pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy.   On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced MYALGIA (Body Pain). On 14-Mar-2021, the patient experienced TREMOR (Shaky), DIZZINESS (Dizzy), FEELING ABNORMAL (Brain-Fogged), DIZZINESS (Lightheaded), VOMITING (Vomited) and FATIGUE (Tired). The patient was treated with DIAZEPAM (VALIUM) at an unspecified dose and frequency. At the time of the report, TREMOR (Shaky), DIZZINESS (Dizzy), FEELING ABNORMAL (Brain-Fogged), DIZZINESS (Lightheaded), MYALGIA (Body Pain), VOMITING (Vomited) and FATIGUE (Tired) had not resolved.            Action taken with mRNA-1273 in response to the event was not applicable. Concomitant drug was not reported.
I had been working heavily in the yard landscaping and thought that was causing all over muscle soreness and tingling in upper and lower extremities. After a few days the sore muscles did not resolve. It is now the end of November and none of my symptoms have resolved. I get electric shocks down my left shin, up the achilles tendon, in bilat forearms, and hands. It is random pain and strong enough to awaken me at night. Numbness in both feet.
I had my vaccination on 04/07/2021. I started to have symptoms in 02/2022 to include cold and flu like symptoms. I did not test for COVID-19 but I do believe I was COVID-19 Positive.
DEVELOPED A RASH/HIVES/SWELLING IN AREA JUST BELOW MY ARMPIT AROUND MY RIGHT PECTORAL MUSCLE. I NOTICED IT WHEN I WOKE UP FRIDAY MORNING, 4/9/21, THE DAY AFTER MY SHOT AND IT STAYED WITH ME UNTIL SOMETIME DURING THE DAY MONDAY, 4/12/21. THE SHOT WAS GIVEN IN MY RIGHT ARM
Patient came in for another vaccine and asked me to look at her arm. She said when she got her FLU shot her arm swelled and made a "cyst". She said it was painful, but not now. I felt the cyst and it was lower than her deltoid. Also it was positioned further back than her deltoid. Advised her to seek attention from PCP.
Focal Seizure...unknown date since my son didn't tell us until his grand mal seizure on Feb 25, 2017, which was 4 days after the meningitis shot.
We gave patient his second vaccinate at day 17 and not day 28. Patient was an inpatient in room, the clinic received request that his attending MD had approved him to receive a Covid vaccine. The RN up to the unit to vaccinate patient, she was not able to find patient in the system, and believed he may be a first dose, before vaccinating him she confirmed with the charge nurse he did need the vaccine, which the charge nurse did confirm. Nurse vaccinated patient and returned to the clinic to finish her system documentation . We were notified on 2.2.2021 that we had 2nd dose vaccinated patient sooner than recommended.- his first vaccine was on Jan 14th 2021,
pain in his arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (pain in his arm) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in his arm). At the time of the report, PAIN IN EXTREMITY (pain in his arm) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The caller reported an adverse reaction that his son experienced (AE-00016849/C-INT-0003181). While he was reporting that, he mentioned that he also received the Moderna vaccine and had also experienced pain in his arm for 3 days. He doesn't want to report anything more about this, he doesn't want to be contacted about this. He just wanted to report about his son. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-714200, US-MODERNATX, INC.-MOD-2023-714201 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714200:Mother-In-Law US-MODERNATX, INC.-MOD-2023-714201:Son
NO ADVERSE EVENT ON CHILD ONLY THAT HE DID NOT GET THE FULL DOSE OF THE 2 PART VACCINE.
Evening after the dose I developed fatigue, a headache and chills. They cleared up by morning. The injection site began to swell and was red from day 2 through day 4 and then cleared up as well.
Extreme headache, and weakness in the body. Felt flew like symptoms for the whole day and could not function
Developed a slight headache, took 2 aspirin, then felt "spacey" for about 2 hours. Also, since I am post menopausal, my left foot was colder at night - after the shot, my right foot was colder (and the left not as much)
Since receiving both COVID vaccines, my husband and I have both felt unusually tired during the evenings and nights. We have a difficult time sleeping and difficulty waking up after a normal amount of sleep (8-8.5 hours). Although we are healthy and physically fit, we feel ?old?; we feel like we have prematurely aged in the last few months.  We did not feel this way before getting either of the Pfizer vaccines.
Hives, crying for hours, high fever & diarrhea.  All subsided within a 2 days
Patient excursion case was accidently used on two patients even though they were no longer suitable for use / no AE; Initial information received on 14-Oct-2021 regarding an unsolicited valid non-serious case received from other health professional, physician and nurse via call center via Medical Information (Reference number- 00813237) in a specific country.  This case involves a 62-year-old female patient who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] that was reported in a past excursion was accidently used (product storage error).  The patient medical history, medical treatments, vaccinations, concomitant medication, and family history were not provided.  On 11-Oct-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot UT7315JA and expiry date: 30-Jun-2022] via an intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error due to product storage error due [Latency: on the same day].  It was reported "nurse states the FLUZONE QIV that was reported in a past excursion case was accidently used on two patients even though they were no longer suitable for use. Nurse was looking for information regarding if they need to re-vaccinate the patients and any possible adverse effects."  2 separate patients accidentally received FLUZONE QUADRIVALENT after an excursion that were aware that they were not supposed to use the FLUZONE QUADRIVALENT.  At time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
Started to develop back pain that spread through out my lower body.  Went to emergency clinic and received two shots for pain relief Problem persisted for three plus weeks managed with pain relievers.  Ultimately diagnosed as sciatica but that was only to describe location of pain.  Meds and physical therapy continued for several weeks.  Pain made it difficult to walk, stand .  After several weeks, pain stopped and I needed to continue physical therapy to strengthen muscles.  FYI, I had a similar reaction during a heart scan with contrast injection.  However, the symptoms only lasted about fifteen minutes while the tech had me pant taking deep breathes.  Do not know if these reactions are related.  I would like to know the recommendation for me to proceed to get vaccinated to develop immunity.  I am scared to take a second shot but will do so if recommended although I read the second shot is stronger than the first. Is it possible to take a booster shot or something else that would have less likelihood of a similar reaction.  It was terrible although I am pretty much fine now.  Thank you
A medical assistant reported the occurrence of an injection site reaction in a 6 month old female who received Infanrix. The subject's medical history, concurrent conditions, and concurrent medications were not specified. On 12/16/01, the vaccinee received her first injection of Infanrix without adverse event. On 2/16/01, the vaccinee received an injection of Tripedia without adverse event. On 4/18/02, the vaccinee received an injection of Infanrix (547A2). On 4/20/02, she developed an injection site reaction characterized by a large lump (knot) and redness. She was seen by the physician. The reporter stated that these adverse events were probably related to Infanrix administration. The outcomes of the events were unknown as of 4/22/02.
diarrhea, Congestion, Chills, runny nose, body aches, headache. starting 11/6/21
Tested Positive for Covid.  Supposely had 1st vaccine on 1/7/2021 but not in immunization registry.
Its hard to walk.; Lower back pain; 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 60 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 29Mar2021 13:30 (Lot number: ER8732, Expiration Date: 31Jul2021) at the age of 60 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious) with onset 30Mar2021, outcome "not recovered", described as "Lower back pain"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "Its hard to walk.".  Additional information: Patient has no history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines were administered on same date of the Pfizer Suspect. No history of prior vaccinations within 4 weeks of suspect administration. The patient did not visit Emergency room and Physician office. No prior vaccinations within 4 weeks. No AE(s) following prior vaccinations.  No follow-up attempts are possible. No further information is expected.
July 9, 2021 HPV 9-valent IM (Merck) lot T028583 in right deltoid. 11/2/21: symptoms not improved: Brain fog, dizziness w/ balance interruption, paresthesia, 2 fingers and toes & daily hot flashes that last 5-10 minutes.  Menses has ceased.  Hormonal labs ordered plus HH, HCG, iron and ferritin. 13yo lightheadedness, shakiness, burning sensation & itching at site HPV vaccine.  Pt taking Zyrtec & Benadryl w/o improvement.  Developed hot flashes, dizziness, paresthesia to fingertips and lower extremities, nausea, & brain fog.  Dizziness affecting balance at times and pain with ambulation at times.  Hot flashes, dizziness & paresthesias daily.  Nausea & brain fog occur intermittently. Pt states menstrual cycles stopped June 15 after HPV vaccine.  Cycles have been irregular, occurring every 2 weeks prior to immunization.
Persistent R shoulder/delt pain, 4/10 pain, only with overhead activity of his R arm, sharp, localized to the delt/shoulder area, and does not radiate down his arm. Did not remember anything unusual about the vaccination -- no excessive bleeding, no post-injection swelling/redness, no excessive pain at time of injection.
pt recvd vax & 1 hr later pt devel swelling & pain in the arm of inject which spread up to jaw & face & c/o lt side of face was tight & swollen; dx parotiditis; pt noted lt arm & ax soreness & swelling
Chills but no fever; Headaches for one and a half weeks; Dizziness; This is a spontaneous report from a contactable consumer reported for herself.  A 94-year-old female consumer reported that received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), on 06Feb2021 12:00 AM (at the age of 94-years-old) at single dose for COVID-19 immunization. medical history included Allergies to Penicillin. Concomitant drugs were unknown. On 08Feb2021 the patient had chills but no fever. Headaches for one and a half weeks and Dizziness. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Chills, headache and nausea. Patient thought she was having an allergic reaction. Counseled on a true allergy. Told patient to contact pcp if symptoms continue.
Information has been received from a medical assistant referring to a currently 16 years old patient of unknown gender. The patient's medical history, current condition and concomitant therapy were not provided. On an unknown date, the patient received dose of improperly stored PROQUAD (lot number R017628 with expiration date 18-DEC-2019) subcutaneously for prophylaxis or VARIVAX (route was unknown, lot number R018931 with expiration date 02-JUL-2020; lot number R018777 with expiration date 01-JUL-2020) for prophylaxis(product storage error). The administered doses experienced a temperature excursion ranged from -14 degree Celsius to -10 degree Celsius for 1 hour and 30 minutes. No previous excursions were reported. The temperature excursions were detected by a data logger. No adverse effects were reported in the patient. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1812USA000015: US-009507513-1812USA000016.
She was vaccinated on 5/29/21. She is now hospitalized on 7/5/21 due to cough, fever, nausea, vomiting and diarrhea. She is still hospitalized.
given at Pharmacy Reoccurring itching on deltoid muscle where the shot was given.  Had small inflamed reaction site for about a month after shot but now I just have intense itching reoccurring at the site.
Pt. states that after receiving the 2nd dose of Moderna 04/24/2021, started experiencing symptoms 10/01/2021 of continuing pain throughout the (right) arm. Upon injection slight pain at the injection site continuing with lingering pain traveling throughout.
1 day after my first dose, the left side of my lower cheek area was swollen. 2 weeks later I experienced very bad cystic acne on my chin area that lasted almost 2 months. After the acne subsided, the edges of my lips got very raw, red, inflamed, burning sensations, and very dry. By early May I noticed my left side cheek swelling again, with still burning, red lips coming and going. By mid June my face swelling had gotten worse. I did not experience any pain or discomfort from the face swelling at any time. At the time of this submission, my face swelling as improved some but is still present.
The patient MAY have received a dose of Janssen vaccine that was administered after the Beyond Use Date.  The provider may have given the dose outside of the 6 hour window after the vial was opened.  No symptoms or signs.  Pt will be contacted and offered to be re-vaccinated to offer full protection, per our Medical Group.
Blurred vision in the right eye; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received single dose of bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration on 21Jul2021 (Batch/Lot Number: EW0198) as, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced blurred vision in the right eye on an unspecified date. The outcome of the event was unknown.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild
2 wks post vaccine -> myalgia/fatigue. Wt loss. Ultimate diagnosis Addison's Disease 8/09.  10/26/2009 PCP and Endocrinologist records, initial visit 8/13/2009. Patient with c/o's fatigue, arthralgias, myalgias and an 18 lb unexplained wt loss. Baseline cortisol levels were <1, patient dx'd with Addison's disease. Tx: started on hydrocortisone bid.
FEVER; INFLAMMATION IN RECTAL MUSCLE; VERY SORE; MUSCLE PAIN; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 11-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUL-2021, the subject experienced inflammation in rectal muscle. On JUL-2021, the subject experienced very sore. On JUL-2021, the subject experienced muscle pain. On JUL-2021, the subject experienced headache. On 18-JUL-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 37.4ºC. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from muscle pain, headache, and fever, and the outcome of inflammation in rectal muscle and very sore was not reported. This report was non-serious.
Patient tested positive for COVID-19. He was hospitalized due to falling frequency, fatigue, and worsening gait. Patient died.
This is a 37 year old female.  Within 10 minutes of her 1st dose Moderna, the patient developed a mild rash (location not specified).  She took a dose of diphenhydramine with some relief.  She went home.  2.5 hours later, she developed a facial twitching and reported to the ED.  She reported involuntary facial muscle twitching, like spasms, that were painful.  On ED presentation, BP=121/86, HR=93, RR=16, SpO2=98%.  ED noted no swelling, itching, SOB, chest pain, N/V/D, or rash.  The ED notes describe the symptoms as "Numerous and varying facial movements including contraction of the lower cheek muscles on the left and then the right along with movement of the tongue from side to side at which point she bites or gets the tongue in the way while trying to speak.  Speech is therefore slurred however at times clear. Oropharynx is clear with mildly dry mucous membranes.  No oral or pharyngeal swelling, difficulty swallowing, or stridor.  Neck is supple and nontender without adenopathy. Differential diagnosis includes: allergic reaction, dystonic drug reaction (unusual to be varying from the left to the right), dyskinesia, anxiety, somatization or conversion disorder, among others.  Her symptoms are not consistent with Bell's palsy, stroke, or clearly tardive dyskinesia. Subsequently given diazepam, fentanyl, and 500mL IV fluids."  She was discharged home.  Patient returned to the ED on 12/31 (within 24hrs) with ongoing symptoms.  Patient was monitored and discharged home again.   One month later, on 1/28/21, chart notes indicate that she has continued to have intermittent symptoms continue.  A trial of steroids reportedly made symptoms worse.  She reports that she also feels fatigued and with 'brain fog.'  She currently has a neurology consult pending.