chrisvoncsefalvay/vaers-outcomes huggingface dataset:
temperature excursion due to refrigerator data logger malfunction low of 15.22 F 47 min with no ae; product being administered not suitable to use post temperature excursion with no adverse event; Initial information received on 09-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional.   This case involves a 9-month-old female patient who reported HIB (PRP/T) VACCINE [ACT-HIB] product being administered not suitable to use post temperature excursion with no adverse event and temperature excursion due to refrigerator data logger malfunction low of 15.22 f 47 min with no adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (DTAP) for Immunization; Polio Vaccine Inactive (IPV) for Immunization; and Hepatitis B Vaccine (Hepatitis B Vaccine) for Immunization.  On an unknown date, it was reported that temperature excursion occurred due to refrigerator data logger malfunction low temperature of 15.22 Fahrenheit and time 47 min with no ae (product storage error).  On 08-Jun-2022, the patient received suspect ACT-HIB vaccine post temperature excursion at dose 0.5ml once intramuscular (lot uj633aaa, expiry date: 30-Nov-2022) via intramuscular route in unknown administration site for prophylactic vaccination (poor quality product administered, latency: same day).  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 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.
No additional AE reported.; expired dose of PROQUAD was administered to a patient on 7SEP2022; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 07-SEP-2022, the patient was vaccinated with expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA) subcutaneous injection, 0.5 ml, for prophylaxis (anatomical location, and route of administration were not provided), lot # U007504 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA), expiration date upon internal validation established as 04-SEP-2022 (the same as reported) (expired product administered). Administered vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) was not involved in temperature excursion through the date of administration.  There were no adverse events reported (no adverse event).
Patient was given MMR vaccination on 04/08/2019 with an expiration date of 04/05/2019
This medically confirmed spontaneous report (initial receipt date: 27-APR-2011) concerns a 76-year old female patient, who had a medical history of chronic pruritus. She had no known allergy. Concomitant medication included hydroxyzine, hydrochlorothiazide; lisinopril combination and estrogens conjugate. On 04-NOV-2010 the patient received a flu shot (brand name unspecified) in her right arm. On the same day the patient also received PNEUMOVAX in her left arm. When a call was made to the patient on 04-DEC-2010, the patient complained of a 5 inches area on her left arm that was red, hot and swollen. The area was getting bigger. The patient 'was faint' and nauseous last night. There was no improvement since 01-DEC-2010. The patient was treated with ice packs and paracetamol. The patient subsequently presented to the clinic complaining of rash and redness on left arm with no pain or fever. She was later diagnosed with VL (very low) superficial cellulitis / lymphangitis to her left arm. The site of injection had no induration or warmth. She was prescribed with a course of cephalexin and advised to call up the clinic if symptoms persisted. The event outcome was not specified.
Patient fainted in the waiting area after receiving her vaccination.   Paramedics were called.  While talking to the paramedics she began to faint again.  They transported her to the ER.  She was released from the ER
Patient report she received the 1st Moderna vaccine lot number 039K20A in her right arm on 12/31/2020 at  0856 at the vaccine clinic. Patient reports her arm was sore for a couple of days. Patient reports on  1/9/2021 she noted itching, redness, and swelling at injection site. Patient is improving today.
tested positive for COVID-19 2 days after my first dose of the vaccine; This is a spontaneous report from a contactable consumer (patient). A 23-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and Expiration date was unknown) via an unspecified route of administration on 06Apr2021 (at the age of 23-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was none. The patient concomitant medications in two weeks included fluoxetine (FLUOXETINE) taken for an unspecified indication, start and stop date were not reported. Patient had no known allergies. Other vaccines in four weeks prior to vaccination was none. The patient reported that, tested positive for covid-19 2 days after my first dose of the vaccine on 08Apr2021. The patient underwent lab tests and procedures which included sars-cov-2 test that was positive on 08Apr2021. Patient reported that, she tested positive for COVID-19 2 days after her first dose of the vaccine on 06Apr2021 after experiencing what she believed were side effects. The patient underwent lab tests and procedures which included SARS-CoV-2 test; Positive on 08Apr2021. The outcome of event tested positive for COVID-19 2 days after my first dose of the vaccine was unknown.    No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Vaccine expired on 02/04/2022 and was given on 02/09/2022. We called Pfizer and they stated that the vaccine has a shelf life of 14 days after expiration, that there was no treatment needed and no need for a repeat dose. Patient reported no adverse effects.
Pulsatile tinnitus 8000 Hz developed in both ears 2-3 days after booster shot. Louder in left ear than right. Noticeably louder in mornings, but still loud even when driving with studded winter tires and the heater on. Only stops pulsing while I yawn and becomes a steady whine. When yawning stops, goes back to pulsatile. Has not diminished in severity since it developed.  Have not gone to a doctor. Waiting for it to resolve (hopefully)
Pharmacist did not perform intramuscular injection properly and underdosed - majority of injection was wasted (ran down patient arm) and did not go into muscle.
After covid booster vaccination , later that evening lymph nodes swelled underarm. 2 1/2 days after vaccination got hives all over .
Discoloration on my right forearm (which was the injection arm) of about 5 1/2 centimeters; a narrow red strip which I took to be a bruise.  Its presence was a surprise, as I had no recollection of any cause of which I was aware.  There does not appear to be any break in the skin, and there is no pain associated with the rash; it does, however, resemble the picture of shingles in the Zostavax literature, and has remained unchanged in the last two or three days.  This may indeed be a bruise and therefore, a coincidence, but as one who is curious, I wanted to report to you.
tender lymph node; lump at the injection site; red, indurated, and itchy lump; red, indurated, and itchy lump; red, indurated, and itchy lump; This spontaneous case was reported by a nurse and describes the occurrence of LYMPH NODE PAIN (tender lymph node), VACCINATION SITE MASS (lump at the injection site), VACCINATION SITE PRURITUS (red, indurated, and itchy lump), VACCINATION SITE INDURATION (red, indurated, and itchy lump) and VACCINATION SITE ERYTHEMA (red, indurated, and itchy lump) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LYMPH NODE PAIN (tender lymph node), VACCINATION SITE MASS (lump at the injection site), VACCINATION SITE PRURITUS (red, indurated, and itchy lump), VACCINATION SITE INDURATION (red, indurated, and itchy lump) and VACCINATION SITE ERYTHEMA (red, indurated, and itchy lump). The patient was treated with IBUPROFEN at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, LYMPH NODE PAIN (tender lymph node), VACCINATION SITE MASS (lump at the injection site), VACCINATION SITE PRURITUS (red, indurated, and itchy lump), VACCINATION SITE INDURATION (red, indurated, and itchy lump) and VACCINATION SITE ERYTHEMA (red, indurated, and itchy lump) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jan-2021: No specific follow-up information recorded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report as received from a health care worker refers to unspecified number of patients. The reporter stated that an unknown number of doses of (Oka/Merck) VARIVAX that have been exposed to 11 F for brief periods during defrost cycles had been administered. No adverse effect reported. Additional information has been requested.
This is a spontaneous report from a contactable consumer reporting for his wife's aunt. An adult female patient over 50 of an unspecified ethnicity received PREVNAR 13)at single dose on an unspecified date for pneumonia, suggested by the physician.  The patient medical history and concomitant medications were not reported. The patient could not move her arm, it was kind of frozen on an unspecified date with outcome of not recovered. After about 6 months she still cannot move/lift it above her head, it was kind of frozen on an unspecified date with outcome of unknown. The consumer was wanting to know how common the side effect of limited arm motion is and how it would manifest itself. No follow-up attempts are possible. No further information is expected.
Numbness and tingling on R side of the face with drooping of eyelids and face currently on day7 diagnosed Bells Palsy
screaming non-stop, very hot & red on thigh all the way to the knee, screaming cont for over 3 hrs;
This spontaneous report was received from the pharmacy student and refers to a 72-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies was provided. Concomitant therapies included LUMIGAN, levothyroxine, liothyronine, COSOPT, fluticasone propionate, azelastine hydrochloride, cephalexin, phenazopyridine, ciprofloxacin, ondansetron, CHERATUSSIN AC, permethrin, meclizine, methylprednisolone, meloxicam, ketoconazole, amoxicillin, polyethylene glycol 3350 and ANUCORT. On 26-SEP-2018, the patient was vaccinated with PNEUMOVAX 23 intramuscular in the left arm (lot # R022232, expiration date: 16-APR-2020) for prophylaxis. On 27-SEP-2018, the patient called the pharmacy to report that the injection site was painful and warm to the touch and that the pain radiated from the injection site down her entire left arm and into her left hand. The outcome of the events was unknown. The relatedness between the events and PNEUMOVAX 23 was not reported.
Headache, Myalgia, Fever, chills, fatigue   Narrative Fever 101, chills, myalgia, headache, fatigue; taking APAP   Other Relevant History:
Pt. states she woke up at 1:00am with severe shaking of her body, chills, and fever. Her son called an ambulance and she was taken to the ER. She states that the ER doc said she was having withdrawal from pain meds. Pt. denies this and states that these symptoms were from the quadrivalent flu vaccine. She had never had a reaction to the flu vaccine before.
Soreness and fever begun. Next two days of high fever (101 to 102.5) followed by the onset of pneumonia (diagnosed 10/13/16).
DTap #5 given in R thigh- 48 hours later, thigh with edema + splotchy erythema.  R thigh 33 cm diameter, L thigh 29 cm.  At 72 hours, rash worsened then Sxs largely noticed by 96 hours.
injection site edema and pain for + 2 weeks since injection. Unusual time frame for long term pain at site and localized muscle pain making it difficult to use arms for regular occupational activities required daily since that injection . This is an adverse event reaction for me since I have had COVID injections prior to this 2nd dosing and many other vaccines for polio, MMR, DTaP, pneumonia,etc.....
The best way I can describe it is an amped-up heartbeat.  I would put my hand on my heart and feel a strong beating. When driving I felt my heartbeat through the seatbelt pad.  It lasted for at least two weeks into the third week.
Raised, red itchy wheal at site of injection.  Aprox 6 cm by 8 cm.
Pt. arrived at Health Department at 12:10 complaining of shortness of breath, nausea & vomiting. States she received influenza vaccine at 10:40 AM during a Health Department sponsored flu clinic given at school.
Patient tested positive for COVID-19 and was hospitalized despite full vaccination and booster. Booster was given on 12/21/2021 and patient was hospitalized with COVID-19 on 01/09/2022
Cleared pharmacist verification with no red flags. Administered  in the shot booth in chair and informed patient to wait the designated 15 minutes. Patient seemed fine with no distress. Color normal. I came back into the pharmacy and seen patient doing well. Patient then a couple minutes later stood up and took a couple steps which put her out of my view. technician the asked if she was ok and the I could see the shot booth going  sideways. Then I could see her fall. I then ran out the pharmacy to check and she landed in the chair sitting up right. she was still semi-conscious and I talked to her. I got a pulse and told the technician to call an ambulance. while trying to keep the lady awake she drifted unconscious but was breathing ok. Pulse was low but didn't lose. Had the help of a nurse at this time and ambulance arrived. Patient was awake by this point with drowziness and could talk.
2DEC93 fever f 104.2 went to ER had convuls also had fine, red macular rash; was adm overnoc; adm dx febrile convuls, URI; WBC 10.700; 6DEC93 seen by MD dx pharyngitis, OM, poss react to MMR;
The day after I received the first dose of my vaccine, I felt numb on my tongue, around my mouth, and hands. In addition, I also experienced a low fever. Then on the third and fourth day, I stated to feel numb on my arms, thighs, fingertips and the bottom of my feet.  I also started to feel chest pain, back pain, and experience migraines. I've felt very tired throughout this time, had a dry mouth. The tops of my feet and hands were slightly swollen and my veins were much more prominent as well. The palm of my hands are always very warm and have a visibly pink color. During this time frame, I've seen also seen my GP twice. As of today, overall, all of these symptoms have lessened in severity. Although the feeling of numbness has also lessened in severity as well, the slight feeling of numbness is still present as of today-especially on my tongue (23 days after my first dose of the vaccine).
Day of injection: weakness and site pain Next day: Fever, skin hot but shivering cold (chills), headache, body aches Day 2: same as next day but less severe
4/10, 9:30 pm: chills, sensitivity, fatigue, arm pain at site of injection 4/11, 12:00am: dry heave followed by vomiting, extremely shakey, and fever. 12:52am: larger watery vomit, more shaking.
36 hours after vaccine:  Pain in left side of abdomen, vomiting, diarrhea for approximately 5 hours.   1 week after:  pain in left side of abdomen and vomiting approximately 4 hours   9 days after vaccine urinary tract infection
Fever - 6 hours - 99.1-100.5 (high for me) Chills- 3 hours - shaking very hard Joint Aches - 16 hours Muscle Aches - 16 hours Bone aches (not just in joints, but the bones) - 16 hours Headache - 8 hours Sore arm - 3 days
heat and rash at the injection site; swelling, heat and rash at the injection site; rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (heat and rash at the injection site), VACCINATION SITE SWELLING (swelling, heat and rash at the injection site) and VACCINATION SITE RASH (rash at the injection site) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (heat and rash at the injection site), VACCINATION SITE SWELLING (swelling, heat and rash at the injection site) and VACCINATION SITE RASH (rash at the injection site). At the time of the report, VACCINATION SITE WARMTH (heat and rash at the injection site), VACCINATION SITE SWELLING (swelling, heat and rash at the injection site) and VACCINATION SITE RASH (rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Crying, not wanting to walk  Left thigh, red, warm to  touch 5x6 inches long
Complaint of bruise at injection site and pain at top of shoulder inside, Saturday PM and 4 days later still painful.  One week after on 10/23 complaint of excruciating pain, 8 of 10 point scale, cannot raise left arm above head without pain.  Saw physician who diagnosed tendonitis and prescribed Motrin and arm rest.  12/02/2005 follow up call states still restricted range of motion and following up with doctor.
Both injections I got Covid Arm; Both injections I got itchy surrounding my injection location; Both injections I got hard welt surrounding my injection location.; hard welt surrounding my injection location; Both injections I got red surrounding my injection location; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Both injections I got Covid Arm), VACCINATION SITE PRURITUS (Both injections I got itchy surrounding my injection location), VACCINATION SITE URTICARIA (Both injections I got hard welt surrounding my injection location.), VACCINATION SITE SWELLING (hard welt surrounding my injection location) and VACCINATION SITE ERYTHEMA (Both injections I got red surrounding my injection location) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 006C21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Drug allergy (Sulfur-based medications).   On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced VACCINATION SITE REACTION (Both injections I got Covid Arm), VACCINATION SITE PRURITUS (Both injections I got itchy surrounding my injection location), VACCINATION SITE URTICARIA (Both injections I got hard welt surrounding my injection location.), VACCINATION SITE SWELLING (hard welt surrounding my injection location) and VACCINATION SITE ERYTHEMA (Both injections I got red surrounding my injection location). The patient was treated with ARNICA MONTANA for Vaccination site swelling, at an unspecified dose and frequency. On 06-May-2021, VACCINATION SITE REACTION (Both injections I got Covid Arm), VACCINATION SITE PRURITUS (Both injections I got itchy surrounding my injection location), VACCINATION SITE URTICARIA (Both injections I got hard welt surrounding my injection location.), VACCINATION SITE SWELLING (hard welt surrounding my injection location) and VACCINATION SITE ERYTHEMA (Both injections I got red surrounding my injection location) was resolving.            No concomitant medications were reported.  Other treatment medications taken by patient were took Arnica tablets/Cold & Warm Compresses until the swelling subsided.
Swollen lymph nodes; Internal neck pain both sides of lymph nodes; This is a spontaneous report from a contactable consumer (Patient). A 36-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6201 and expiry dates were not provided), Intramuscularly administered, at arm right on 19Feb2021 11:00AM (at the time of vaccination 36-years-old), as a single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient did not receive other vaccine in four weeks of vaccination. The patient previously took first dose of BNT162B2 (lot number: EL9263) on 27Jan2021 05:30 PM (at the age of 36-years-old) in left arm for COVID-19 immunization. It was reported that the patient had experienced swollen lymph node on the side of her neck (one week after the 1st dose), Internal neck pain both sides of lymph nodes (2 weeks after the second dose). Patient did not receive the any treatment for both events. Outcome of the event swollen lymph node on the side of her neck was resolved with sequelae and for event Internal neck pain both sides of lymph nodes was not resolved.   No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Pt recv vax in Fall '97; post vax pt exp chronic persistent hematuria of glomerular origin
Temperature 39.7 C, Muscle pain and soreness of the posterior of the thighs and hips (both sides), smells a fishy odor that is causing a decrease in appetite. Continues to have symptoms. Instructed to use Tylenol by family physician, husband complained that it did not help with the pain and soreness but did help the temperature.  Advised to use ibuprofen instead.
Patient with history of COVID-19 vaccination admitted to hospital with COVID detected test. Per discharge summary, "70 yo male with pmhx CAD s/p PCI, HTN being admitted with NSTEMI. Pt states that his pain started about 1pm. He was roofing at the time, but he wasn't exerting himself significantly. He had COVID perhaps 2 weeks ago."
Death from enlarged heart, and out of control Diabetic Ketoacidosis after second dose of Moderna mRna Covid -19 vaccine
Medication was expired - expired on 8/1/21 - and administered on 8/25/21
Crying every hour. Tmax 103.2 at 0300 5/14/13.
This case was reported by a physician via a sales representative and described the occurrence of fever in a subject of unspecified age and gender who was vaccinated with Pediarix for prophylaxis. On an unspecified date, the subject received an unspecified dose of Pediarix (lot number not specified). Concurrently, the pt also received Prevnar. On an unspecified date approximately 4 days after vaccination with Pediarix, the subject developed a fever. At the time of reporting, the outcome of the fever was unspecified.
Below the shot sight there is 3X5 square patch, that seems to be warm to touch.