chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little bit of a sore arm), ABDOMINAL DISCOMFORT (stomach upset or his stomach's not feeling well), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (body aches) and NAUSEA (Nausea) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No adverse event history). On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (little bit of a sore arm). On 18-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach upset or his stomach's not feeling well), PAIN (body aches), NAUSEA (Nausea), PYREXIA (fever), CHILLS (chills), FATIGUE (fatigue) and HEADACHE (headache). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 28-Feb-2021, PAIN IN EXTREMITY (little bit of a sore arm) had resolved. On 20-Mar-2021, PYREXIA (fever) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (stomach upset or his stomach's not feeling well), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (body aches), NAUSEA (Nausea), CHILLS (chills) and FATIGUE (fatigue) had resolved and HEADACHE (headache) had not resolved. Not Provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Chest X-ray: negative (Negative) Negative. On 18-Mar-2021, Influenza virus test: negative (Negative) Negative. On 18-Mar-2021, SARS-CoV-2 antibody test: negative (Negative) Negative. No concomitant medications were reported. Patient was seen in the ER on 18-MAR-2021 for treatment of his symptoms.  He was treated with Tylenol and released.  Patient reports he has a follow up appointment scheduled with his HCP.  He grants permission for Safety Follow-up. Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Follow up received, Patient details updated, event of flu like symptoms updated.
I was very sick with all the regular symptoms for 2 days; headache, all over pain, nausea, fatigue, extremely cold feet, chills.  In addition to symptoms above, I also loss part of my vision. I couldn?t read because I couldn?t see the entire print. I did not go to hospital or call doctor. I went to bed because I felt so bad. The next morning my vision was back to normal.
Bone and joint pain in the arm the vaccine was received in. Applied heating pad, kept elevated with a pillow, took ibuprofen for pain. Symptoms lasted about 16 hours at a pain scale of 8/10. Today it?s more tolerable at about a 4/10
The night of the vaccine, patient began having terrible headaches. She has missed almost seven weeks of school. They vary in intensity but do not go away. To date, we have been to our pediatrician, the ER, a neurologist, and had an MRI. So far, no medicine has worked to stop the headaches.
The day after the shot I was very lethargic and my legs felt like lead.  Appetite and desire to go about my daily routine were drastically impacted.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021 at 12:55 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 12:55 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 65.68  No concomitant medications were reported.  Product moved to clinic on 13-Jan-2021. Vial was moved to fridge on 09-Feb-2021. Batch number 031L20A underwent temperature excursion on 13-Feb-2021 with temperature 32 degrees Fahrenheit from at 9 AM. Beyond use date for the vial was reported as 10-Mar-2021.   Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
A hard bump at the site of the vaccine appeared today. It is raised, about 1.5 inches long, red and hot to the touch.    Treatment: Just letting it be as it is a side effect from the vaccine.
worsening Vasomotor sxs/ night sweats/ hot flashes increased frequency of complex migraines
Patient had a syncopal episode in parking lot about 10 - 15 minutes after receiving vaccine.  Mother assisted to ground.  Patient taken to acute area for evaluation immediately afterwards.  Patient treated for vasovagal syncope and abrasions to knees cleaned and dressing applied.
Neuropathy in bilateral feet, numbness/tingling/pibs&needles, cold sensitivity in bilateral hands/fingers
103 degree fever within 24 hours of vaccination for 24 hours. Rash/Hives all over body began 7 days after vaccination. Hives/Rash continued sporadically for 2 months. Within 30 days of vaccination developed RAD which has now been linked to allergies to Dairy and Soy. No such allergies before vaccination. Emergency Room visit for RAD required on three separate occasions.
Patient presented for Moderna Booster.  Vaccinated without incident.  One hour after vaccination thru an interpreter developed complaint of substernal/epigastric pain.  Felt light headed. No respiratory distress.  0x 98%; BP 130/80.  Called 911.  12 lead EKG done.  Normal but PVC every  4 -5 beats.  blood sugar 133; repeat BP 120/89.  Paramedics offered to transport patient but he refused stating pain was improving.  Wife and patent understand need to call 911 if symptoms return or worsen.  They were advised to see PCP and they agreed to call clinic to schedule an appointment.  Patient and wife left.
After taking the vaccine, the next day, I cut my finger while making a salad and I bleed for a long time.  It was like 3 1/2 hrs my finger bleed.  It seemed unusual but nothing I couldn't handle or out of control.  I just wish they had informed me so I would have taken extra care when handling the knife.  I'm not sure if this was related to the vaccine but I had never bleed that long before so I wanted to report it as a potential side effect.  I still think benefits of vaccine outweigh risk involved with vaccine so I am glad to have had the shot.
Arm is painful, swollen, & has redness around the injection site that looks like a set of eye glasses with a red circle around the site a small red bridge then another big red area.
No additional AE information provided; PNEUMOVAX 23 vaccine was accidentally administered to a patient after the expiration date; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 03-NOV-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) syringe, injection, 0.5 ml, lot number U003306, expiration date: 15-OCT-2022, administered for prophylaxis (strength, and route of administration were not provided) (expired product administered). It was reported that the vaccine was stored appropriately and did not have any temperature excursions. No additional adverse event information was provided (no adverse event).
indication=Treatment of COVID-19; indication=Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient received BNT162b2 (BNT162B2), on 10Nov2021 as dose 3 (booster), single (Lot number: en107), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diffuse Large B Cell Lymphoma" (unspecified if ongoing). Concomitant medication(s) included: VALACYCLOVIR HCL, start date: 31Jan2022, stop date: 22May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Body temperature: (10May2022) 100.3, notes: Fever never over 100.3. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow up attempts are needed. No Further information is expected.
1. 3/13 @230pm fever 101.6, took Tylenol and temperature went to 99.7 by 430pm. Have been cold (chills) since having the vaccine on Friday, though not feverish throughout.  2. 3/14 @ 0830am red and raised  rash from above shoulder mid upper arm, raised higher at injection site  3. 3/14 @ 0515pm lower lip (left side) swollen, red and numb. Sore inside roof of mouth (left upper). Tongue slightly swollen, but not hindering breathing.
Patient received shot on Friday night and was feeling fine for the next four or five days. Then on Tuesday afternoon she first started feeling itchy at the shot area and later it turned red and swollen and hard to the touch. She came to the pharmacy, spoke with the pharmacist and was advised to take some OTC Benadryl.  Today she reported the right arm area is soften, less red, less itchy and she thinks it is a lot better. However, the area still looked red and swollen and I encouraged her to call her primary care physician as per discussion during vaccination process. I encouraged patient to keep the shot area clean, continue OTC  Benadryl  and apply ice if needed. She is visiting with her primary care physician today to see if further treatment is needed.
Started to get a headache about 8 hours after. At 330am I got chills and massive headache. Headache, fever, nauseous, and fatigued all day long. Slept all10 hours and woke up on the second day after still with a headache and fever as I am filling this out
A healthcare professional prospectively reported the occurrence of neonatal jaundice in a newborn female neonate subject who was exposed in utero to Twinrix via the placenta. the subject's mother was vaccinated with Twinrix (GlaxoSmithKline) for prophylaxis. The subject was also exposed in utero to maternal concurrent medications that included prenatal vitamins and Lipil. Maternal history included smoking one-half pack per day of cigarettes. On 06 April 2007 the mother received 3rd dose of Twinrix (1 ml, unknown, left arm). On 17 April 2007, the mother notified the physician's office that she was pregnant and "found out last week." The mother received 3rd dose of Twinrix at approximately 6 weeks of gestation. Prenatal test showed no evidence of birth defects and the conception was normal. It was reported that, the subject delivered a female infant at approximately 41 weeks of gestation by normal vaginal delivery. The infant weighed 6 pounds 1 ounce and was 18 inches long. APGAR score and head circumference were unknown. No birth defects were noted. It was reported that the neonate developed jaundice and was hospitalized for three days after birth. The infant was treated with intravenous fluids and received light treatments. A check-up was done approximately one and one-half weeks and it was reported that the baby "was fine." Details of the mother case can be found in GSK manufacturer number A0648203A.
Information has been received from a physician concerning a 15 year old female who was vaccinated with Gardasil, Varivax, and MENACTRA on the same day and fainted.  The patient outcome was not provided.  No further information is available.
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 70-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 12-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250795, expiry date: 30-Apr-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805490 was crossed linked to original case 201804863 due to same reporter.
Disease (multiple myeloma) exacerbation; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PLASMA CELL MYELOMA RECURRENT (Disease (multiple myeloma) exacerbation) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 029K20A) for COVID-19 vaccination.     Concurrent medical conditions included Multiple myeloma in remission (in remission more than 7 months).   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced PLASMA CELL MYELOMA RECURRENT (Disease (multiple myeloma) exacerbation) (seriousness criterion medically significant). At the time of the report, PLASMA CELL MYELOMA RECURRENT (Disease (multiple myeloma) exacerbation) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Blood test: "went in roof," "significant change in blood count (abnormal) "Went in roof," "Significant change in blood counting".         The patient had multiple myeloma and was in remission more than 7 months at the time of the first vaccine dosing on 20-JAN-2021.  Treatment information was not reported.  Based on the mechanism of action of mRNA-1273, the event is assessed as unlikely related to mRNA-1273.   This case was linked to MOD-2021-098777 (Patient Link).; Sender's Comments: Based on the mechanism of action of mRNA-1273, the event is assessed as unlikely related to mRNA-1273.
w/in 5mins of vax pt c/o feeling weak & dizzy the face changed from good color to white & pulse was barely palpable;pt was placed in shock position on the floor w/feet up in chair w/in 5 mins color returned,P80,resp 21
A report was received from a health care professional on 9/2/03 concerning a 52 year old male vaccinee who inadvertently received expired Fluvirin vaccine on 9/2/03. On 9/2/03, the vaccinee inadvertently received 2002-2003 Fluvirin vaccine. No adverse event was reported in relation to the incident. There was insufficient information to determine the reporter's causality assessment. Update 2/16/04: A follow up report was received from a health care professional indicating that no adverse event had occurred at the time of reporting. No follow up pending, all information received. See PJP200300721 and PJP200300722.
Patient cried and would become hysterical if not being held. Patient was repeatedly trying to pinch himself at the injection site. Patient normally doesn't cry long or often cried for 3 hours (almost nonstop) that evening.  The next morning, there was a small amount of blood in the diaper (in the front).
pt recv vax 10MAY95 & w/in 24hr of vax pt devel gen hives & a hyperpigmented area @ inj;The hives were noted to be worse w/the 2nd dose;pt recovered;
within 12 hours of preservative free influenza vaccine had fever 104 and had febrile seizure.  neg w/u.  had clear runny nose/viral illness at time of vaccine
9/19 increased pain, erythema - 9/20 & 9/21  malaise and increased pain and erythema.
May 26, 2007 couldn't walk right - took him to ER they admitted him to hospital at that time. his condition kept getting worse - May 28, 07 he went Code Blue - twice - had ventilator put in and on oxygen - totally paralyzed from that time on. Approx 1 1/2-2 wks later had a spinal tap, found he had GUILLAIN BARRE Syndrome. He couldn't move talk nothing.  8/5/09 MR received for DOS 5/26-6/13/07 with D/C DX: Guillaine Barre Syndrome. Pt presented with arm and leg numbness/weakness. PE (+) for facial droop, dysarthria, sensation loss, upper and lower extremity weakness and difficulty with ambulation.  Progressed to full respiratory arrest and pt intubated and later trached. PEG tube placed. Still very weak and unable to lift arms/legs.  Transferred for intensive rehab.
Immunized at age 8; Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report was received from a physician concerning an 8-year-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, immunized at age 8 and administered vials that were exposed to room temperature for more than 12 hours.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 04 Jan 2021, the patient received a vaccine dose of mRNA-1273 that had been left at room temperature more than 12 hours. It was originally thought that the freezer which stored the mRNA-1273 vaccine died on 04 Jan 2021 at 2am, so vaccine administration occurred up until 2pm. After checking freezer temperature logs, it was discovered the freezer had died at 1:11am. Treatment for the events was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The events, immunized at age 8 and administered vials that were exposed to room temperature for more than 12 hours, were considered resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a 8-year old patient, who was administered the first dose of mRNA-1273 from the vials that were exposed to room temperature for more than 12 hours. This report refers to a case of Product storage error  and Product administration error for mRNA-1273, where out of specification product was administered to the patient of inappropriate age.
Vaccine received in left deltoid 09/20/2018 in the afternoon. On the evening of 09/20/2018 she started experiencing swelling, pain and itching at the injection site.
felt like million dollar; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (felt like million dollar) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (felt like million dollar). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (felt like million dollar) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Treatment information was not provided.   This case was linked to MOD-2021-207524.
This spontaneous report as received from a pharmacist refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unspecified dates since 23-SEP-2015, the patients were vaccinated with doses of improperly stored ZOSTAVAX, lot # L016283, expiration date: 07-AUG-2016, (dose, route of administration and injection site were not reported). No adverse effects were reported. Aditional information has been requested.
Patient administered bivalent Pfizer-BioNTech in error for a primary series dose.   No adverse signs and symptom at time of administration or 15 minutes after while observed in the clinic
Sever pain left armpit and horribly enlarged lymphonode at the injection site. 5 days early menstrual cycle start with extremely heavy bleeding to the point to go to emergency room. ( i have a very regular 28 days period and never experienced any changes though my all life). After that menstrual cycle no period at all. Negative pregnancy test done in the lab ( blood work checked by my doctor) today my period is 15 days late. Never happened to me before in all my life!!!  Every day I experience pain and unpleasant sensations at the pelvic era. Hurts a lot and feels like period should start but it doesn?t. Mood swings ( never had related to mensural cycle before). Reoccurring yeast infection on and off. My belly feels inflated and very heavy like a soccer ball. As of today no signs of period starting. I am very scarred, conserved as I never had any kind of go ecological issues before or any history with menstrual irregularities.  Reported this to my family doctor and was told that a lot of females in her practice experience exactly the same issues and some of them were admitted to emergency with heavy bleeding and had blood transfusion done. All these women still do not have their periods return ( yang and old).  The recommendations are not clear ( seat and wait for 2 months ). as doctors don?t know what is triggering  menstrual problem. What is it???? What should i do?
Exhaustion about 6 hours after. Fever, chills, headache, and muscle pain less than 24 hours later. The muscle aches and exhaustion have continued more than 24 hours later.
Systemic: Blood Disorder  (diagnosed by MD)-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Headache-Medium, Systemic: Tachycardia-Severe, Additional Details: Pt presented to the ER complaining of racing heart, chest tightness, and uneasiness. Pt was sent home without dx. Pt returned to ER and insisted to be seen and that something was wrong. MD diagnosed pt with 2 blood clots in lungs, Causality was not confirmed, but relation to vaccine was not ruled out. Pt has been on blood thinner and did not receive 2nd dose.