chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 51-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Sep2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received Paxlovid as Anti-viral treatment for COVID-19 from 24Aug022 to 29Aug2022. Covid vaccine lot number was unknown since it was misplaced/discarded. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. Device Date was 04Sep2022. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on available information, the events Covid-19 and drug ineffective is assessed as related to the suspect drug BNT162b2.
High pitched cry lasting for approx 5 hrs beginning an hr p/vax; no tx;
9 days after vaccination I developed a firm itchy rash at vaccination site Day of vaccination I developed headache and back muscle aches about 8 hours after shot.
Pfizer BioNTech's COVID-19 Vaccine: 24-hour fever and muscle pain. Nausea and dizziness at 40hrs. Swollen lymph nodes under left armpit and left clavicle.
Cramps in legs, stomach and hands. Weak feeling. One night fever of 102 2/2/06. Urinate every 2 hr at night. Stool normal-no vomit. Lost 5 lbs, no diarrhea or vomiting.
administration of an expired product to a patient with no reported adverse event; Initial information was received on 14-Jul-2023 regarding an unsolicited valid non-serious case received from an other health professional (Pharmacist).  This case involves an unknown age patient of unknown gender who received an expired product of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of an expired suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection (lot number: U7092AA, expiration date: 24-Jun-2023, strength, route, administration site: Unknown) for Immunization (immunisation) with no reported adverse event (expired product administered) (latency: same day).  It was reported that "The product displayed an expiration date of 24-Jun-23. The caller believed that this meant that the vaccine expired 23-Jun-2024. It was administered to a patient. After speaking with the pharmacy technician, the pharmacist came on the line. She explained their confusion in reading the expiration date."  No lab data reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event administration of an expired product to a patient with no reported adverse event.  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.
Information has been received from a physician concerning a 15 year old male who on 29-NOV-1995 was vaccinated with a first dose of MMR II.  On 17-NOV-1999 the patient was vaccinated with a second dose of MMR II.  On 18-NOV-2009 the patient was vaccinated with a third dose of MMR II (lot # 664886/0776Y).  On 27-NOV-2009 the patient experienced mumps (thought the date diagnosed was reported as 18-NOV-2009).  Other symptoms presented by the patient included swelling under right ear.  On 18-NOV-2009 the patient had the following laboratories tests done: serum immunoglobulin G test (7.06), serum immunoglobulin M test (< 1:10), and a serum amylase test (246).  The patient was afebrile and had parotitis.  The patient's outcome was unknown.  Follow up information has been received and indicated that the 15 year old patient (also reported as 13 year old) experienced mumps on 28-NOV-2009 (previously reported as 27-NOV-2009).  The patient was diagnosed on 29-NOV-2009, patient's signs and symptoms included Left parotitis.  The patient was reported as afebrile.  According to the reporter blood work was not done.  The patient's outcome was not specified.  This one of several reports from the same source.  No further information is available.
started with mouth, major headache, body aches ,shortness of breath, fever and chills. 2 weeks later positive for strep. diarrhea with every meal.
This spontaneous report was received from a registered nurse concerning multiple patients of unknown age and gender. It was reported that on unknown dates, multiple unspecified patients may have been administered with an improperly stored VAQTA (lot number, expiry date, dose and route unspecified). VAQTA was exposed to 30 degrees Fahrenheit for 11.5 hours which was not supported. The nurse was unsure if this improperly stored vaccine was administered. No concomitant therapy was reported. This is one of the two reports from the same source. Additional information has been requested.
Severe aches  and pain  Nausea  Headaches  105.1 fever
Patient is a 41 y.o. female who received Covid booster left deltoid 3/1/2022, the following morning which was yesterday she noticed pain in the deltoid area, left axilla with swollen lymph nodes, mild to moderate left-sided and scapular chest tightness that radiates into the neck area, temperature 99.9, chills, sweats, achy all over, mild nausea without vomiting, mild sore throat. Headache yesterday that has resolved. She does not feel short of breath although she has to concentrate to take a full breath.  With 2 prior Covid vaccinations she had significant reaction to the left deltoid and left arm but did not involve the chest. Due to prior reaction she did see her allergist 3/1/2022.  Vomiting began evening 3/3/22.
Pharmacist gave a Johnson + Johnson shot to the patient.  After the shot the patient got up and sat down in a "Post-Vaccination waiting area" chair.  A few minute later the patient got up and walked towards  the pharmacy asking for water, as he was walking to the pharmacist the patient fainted, fell to the ground and bumped his head on the counter.  Patient woke up a several second later confused and laid on the floor.  Code white and 911 was called. Another pharmacist grabbed an ice pack and a bottle of water for the patient.  Patient said he went to the dentist office recently and received a shot in the mouth and something similar happened as well.  The patient did not disclose this information to the immunizing pharmacist.  Patient told us to cancel the 911 call and asked to leave, the pharmacist recommended he stay a while longer so we can monitor him.  Patient said he had no history of diabetes or seizures.  Patient forehead was slightly red.
I63.9 - Stroke determined by clinical assessment (CMS/HCC) I63.9 - Acute ischemic stroke (CMS/HCC)
Persistent crying for longer than 3 hours day of vaccination, cold and clammy in days following vaccinations, coupled with continued bouts of crying not typical of infant.
Irritability for 4 days. Vomiting, dehydration, requiring IV rehydration. Abdominal tenderness. Conducted test resulting in nml findings. Fever of greater than 101 for 24 hours. Anorexia for 48 hours. No reaction at injection site.
Headache, body ache and chills, dizziness and light headed did not eat or drink for two days with fever of 99.8. Husband to me to Hospital. Was put on 24 hour quarters after eating small amounts of food I then had diarrhea for 2 days and returned to Health Care where they gave me a shot in the butt and meds to take for the diarrhea.
pt began screaming & unconsolable approx 3 1/2 hrs p/vax; pt had no fever; pt began jerking about 5 hrs p/vax; seen @ ER; had muscle spasms but no seizures;
CONFUSION, HALLUCINATIONS, FEVER (103), INCREASED BLOOD PRESSURE, CHILLS
MEDICATION ERROR - GAVE 0.5 ML INSTEAD OF THE 0.25 ML THAT SHOULD HAVE BEEN GIVEN FOR THE BOOSTER
Arm pain, swelling, redness, warmth, itchiness started 1-2 days after injection in left arm, redness, warmth continued 6 days later. Required oral systemic steroids.
Sore arm right after injection, followed by dIzziness and then headache. Fatigue set in about 4:30pm. Felt chills and couldn?t sleep well, woke up around 2pm with intense pain radiating down my arm and my headache was worse. Symptoms continued the next day but I took ibuprofen to help manage. Felt fine by 3pm the next day.
blood pressure was notably high; Shingles; severe pain on the top life side of her head; This case was reported by a nurse via call center representative and described the occurrence of shingles in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd August 2019, the patient received the 1st dose of Shingrix. On 21st February 2020, 182 days after receiving Shingrix and an unknown time after starting Valacyclovir, the patient experienced shingles and headache. On 22nd February 2020, the patient experienced increased blood pressure. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the shingles, headache and increased blood pressure were unknown.   It was unknown if the reporter considered the shingles, headache and increased blood pressure to be related to Shingrix.  Additional case details were reported as follows: The patient experienced shingles, headache and increased blood pressure after 1st dose of Shingrix. The patient went to emergency room and underwent a CT scan. The patient blood pressure was high due to severe pain. The patient had no blisters on her head or on her scalp and wanted to receive 2nd dose Shingrix as soon as possible. The patient was not administered with the vaccine because she is taking antivirals. The patient consented to follow up.
Nausea within an hour of shot.  Body aches, Headache,  arm pain and 3 days after shot hives on arm/ looking like mosquito bites all over that arm.  took Benadryl and used benadryl cream for the itching, it was gone in about 24 hours  after use of benadryl.  After second vaccine ~ no reactions except headache.  but I am having allergic reactions to all kinds of antibiotics that I have NEVER been allergic to before.  Red face and eyes, Peeling and blistering skin, lips and face, major itching, rashes (on face).
INTENSE PAIN IN UPPER LEFT SHOULDER. DIFFICULTY IN MOVING ARM AROUND. PAIN IN DELTOID MUSCLE.
Mom reports swelling, redness of left thigh starting 08/17/2005 with pallor. Today mom reports decreased pallor, and on physical exam left thigh (mid) positive pain CRE 27cm, 26.5cm positive edema, pallor. Neurologic visit.
On 8/8/01, pt developed a fever and arm was pink and got worse in the evening. Went to ER; no labs but started on Keflex. On 8/9/01, pt's left arm was more red, more swollen about all of upper arm. On 8/10/01, redness was gone and on 8/11/01 and 8/12/01, swelling was down.
This spontaneous report was received from a registered nurse concerning an approximately 21 year old (at the time of adverse event) female patient with no pertinent medical history and no drug reactions or allergies. On 11-MAY-1992, the patient was vaccinated with the first dose of RECOMBIVAX HB (lot number and expiry date unspecified) intramuscularly. On 06-JUL-1992, the patient was vaccinated with the second dose of RECOMBIVAX HB (lot number reported as 1002A2, expiry date unspecified), intramuscularly. On 06-NOV-1992, the patient was vaccinated with the third dose of RECOMBIVAX HB (lot number reported as 1151V, expiry date unspecified) intramuscularly. There were no concomitant medications. On 13-MAY-2013, the patient was tested for titers via routine blood work at a hospital. The results of the blood work were negative for titer. It was reported that the patient would be getting a fourth dose of RECOMBIVAX HB in the near future. The patient sought a medical attention. No treatment was provided. The outcome of negative for titers was unknown. The relatedness for the event was unknown for RECOMBIVAX HB. Additional information has been requested.
Pain at the  site of injection and difficulty to move arm. Generalized moderate body pain and headache. Symptoms lasted for about 12 hours.
Throat tightness, R arm tingling, Rt side facial numbness. Evaluated by EMS-Cleared
@ approx 515AM 8AUG92 pt began having sz acitivty; no prior hx of seizures; cont w/intermittent sz acitivity x 1 hr;
Shots given in same arm at patient request, 1 inch apart. Arm is swollen from shoulder down to elbow, red, and warm to the touch.
Patient was vaccinated and in the waiting area.  5 minutes after the vaccine patient alerted staff she was having a rapid heart beat.  EMS was onsite and responded.  EMS personnel monitored patient for a short time.  Patient stated she forgot to take her anxiety medication this morning.  Patient returned to her vehicle and waited approx 5 more minutes and felt well enough to go home (husband was driving).  Informed patient to call 911 or present to nearest emergency room if she starts feeling like she is having additional issues.  Patient left site claiming to be feeling fine.
Itching, pain, and rash at injection site. Nausea, dizziness, and tired.
Extreme fatigue, worse the last few days, (today is Feb 01) started about the time of the injection.
Sensitivity and soreness in left arm. Bruising lasted over 3 weeks. After second vaccine, a rash developed under left armpit. Initially the rash was red, bumpy and sensitive. Then rash developed scabs that fell off within a week. 3 weeks later on 4/17/2021, I went to a public place where many people were not masked or not wearing mask correctly. I removed my mask to drink and eat but then put it back on during the rest of my time at the venue. Two days later, the rash came back and now the scabs are back. The rash covers more surface area now and is quite uncomfortable.
Started feeling achy around 4pm, By 8pm was having  shivering and sweats.  By 9pm her arm was in severe pain. Was up all night with pain of 15 on a scale of 1-10 .   Used a sling the next day and pain started subsiding around 12pm and continued to get better over the next few days.
Expired dose administered to patient / Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient / Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient / Dose administered after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient / Dose administered after 30-day Use By Date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The reporter stated that the patient was vaccinated on 02-May-2022 with expired doses of Moderna COVID-19 Vaccine. The dose was administered after 30-day Use by Date or after manufacturer date of expiry. The date when the vial was initially stored in the refrigerator was unknown. Reportedly, the vial didn't undergo any temperature excursions. It was unknown if the patient had experienced any symptoms.  No treatment information was provided.
Patient received  PPV23 on 1/29/2019 and received same vaccine 10 months later. He should have gotten his second dose 1/29/2020 and it should have been Pneumo13.  There were no Adverse Reactions or patient complaints.
8/24/05 at 3:15PM body aches all over, very tired, fever 99.4. Spine and hips holt, cold chills. 8/25/05 continued with fever highest 100.2 bodyaches, hips and legs hurt. Feeling horrible 8/26 Still having temp 99.1 arm hurts. Quarter size knot with fever and redness. Now baseball size w a hard knot red with fever, temp 100.0. 8/26 at 4:32 with headache. At 5:10PM Dr seen and dx'd with reaction to tetanus/cellulitis at injection site given an antibiotic Keflex.
Approx 10 to 12 days after doses 1 and 2 , I developed numbness and tingling in bilateral hands and feet.I also experienced sensation of warmth and coolness in the back of my hands and calves. As of 05/12/21,   I continue to experience the symptoms .As I report this the symptoms have been almost constant for the past 3 days. Ironically two of my cousins and one aunt gave experienced this also with the Pfizer vaccine.
high fever almost 103-104; lots of pain in her chest; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP), Program ID: A 61-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "ankylosing spondylitis" (unspecified if ongoing), notes: ankylosing spondylitis; "rheumatoid arthritis" (unspecified if ongoing), notes: rheumatoid arthritis (primary); "Crohn's secondary" (unspecified if ongoing), notes: Crohn's secondary.; "white blood cell used to be low but now not sure" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Manufacturer unknown), for COVID-19 Immunization.  The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "high fever almost 103-104"; CHEST PAIN (non-serious), outcome "unknown", described as "lots of pain in her chest". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: patient reports that she had to stop taking Xeljanz XR last year after getting her covid-19 (corona virus) vaccines (2 doses) for 2 months, her rheumatoid arthritis was on and off after stopping, patient had severe side-effects from covid-19 (second dose) - high fever almost 103-104, and lots of pain in her chest. patient reports her white blood cell used to be low but now not sure. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
2/19/2021; 15 days after receiving 1st Moderna vaccine. Pt had no complaints other than sore arm and tiredness after vaccination. Skiing with family; walking in ski boots to get skis on. She complained of sudden onset of headache and "not feeling well". Ski patrol was nearby and got her a glass of water. Patient stood up and fell to the ground unconscious. Taken to ski patrol hut; unresponsive with left sided deficits, snoring respirations & trisamus present. Unable to transport to major medical center due to adverse weather. Taken by ambulance to local hospital. CT showed significant hyperdense acute intracranial blood including lateral ventricles, 3rd & 4th ventricles with parenchymal blood in right greater than left bilateral parietal periventricle regions. Left midline shift.  ER Physician: Transported to Medical Center via air & then ambulance due to adverse weather. Overnight in Neuro ICU; brain dead; organ donation.
Pt noted some redness and tenderness of upper right arm following receipt of her 1st JEV vaccination and 05/17/06, but not additional symptoms recalled). Around 2 weeks following her 2nd JEV vaccine (5/24/06), she noted a rash which started on her left arm. She described the rash as starting as redness like a sunburn and then developing red bumps-whelps. Red bumps appear suddenly and resolve within hours; they have appeared on and off for over 6 weeks, primarily on her arms, chest and legs. Most of the time the rash is pruritic. Also notes some petechiae type lesions on her legs that she says are new and not normally there. Denies associated signs and symptoms such as rhinorrhea, wheezing or breathing difficulties, angioedema, headaches, metallic taste, diarrhea or vomiting, hoarseness, cough or tightness of throat. Denies new or unusual foods prior to onset of rash. Denies personal history of asthma, eczema, or environmental or food allergies; specifically denies gelatin allergy.
Information has been received from an 82 year old female patient with no drug reaction/allergies, who on 23-JAN-2009 at about 12:00, was vaccinated with a dose of ZOSTER vaccine live (Oka/Merck).  Concomitant therapy included BUSPIRONE HC1, LEVOTHROID, NIASPAN, MSD, TOPROL XL TABLETS and low dose aspirin.  On the morning of 24-JAN-2009, within 24 hours after she received her injection of ZOSTER vaccine live (Oka/Merck), the patient noticed that she was red at the injection site, sore at the injection site, hot to touch at the injection site, tight feeling at the injection site and swelling at the injection site about the size of a softball.  She did not have any difficult breathing. On 25-JAN-2009, she treated the injection site with LANACANE, but she did not notice any improvement in the symptoms.  There was no relevant laboratory data.  As of 25-JAN-2009, the redness at the injection site, soreness at the injection site, feeling hot to touch at the injection site, tight feeling at the injection site and swelling at the injection site felt as though they were worsening.  The patient planned to contact her physician for additional instruction on treatment of the reactions.  Additional information has been requested.
Case began feeling sick with extreme lethargy, fatigue and mild congestion on 0/17/2022. Due to these worsening symptoms case went to hospital on 05/20/2022, tested positive and was admitted for 2 days.
pt recvd vax 12JUL95 & 23JUL95 pt devel what looked like early chicken pox lesions a/they form vesicles;had a macular, hyperpigmentation around 4-5mm in size, many were smaller;
In December of 1999, the patient developed varicella and a fever. Also reported were "multiple" patients who were vaccinated and experienced similar events. No further information is available.
Patient reports muscle weakness post vaccine and pain hours later continuing to 11th day, says it has been getting better. Says shot seemed high but reports no joint pain or tenderness. Reports no discomfort at time shot was given. Getting better. Has not seen a doctor.
Acute Pancreatitis following administration of dose 1. Got worse after second dose and landed in the hospital following second dose.
Pt started coughing approximately one hour after vaccine administration.  By the time he was home for the day he complained of hoarseness, sore red itchy eyes & a dry cough that would not go away.  Symptoms lasted about five hours.  He took "inhalers" that he had at home to help w/ symptoms.  Later in the evening felt like he was getting "what is going around".  Awoke this morning (11/5/10) feeling "fine".
PT COMPLAINING ABOUT PROLONGED PAIN ( OVER 6 DAYS) AT INJECTION SITE AFTER IMMUNIZATION