chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE details; TE evaluation states vaccines have been administered to multiple patients; This spontaneous report has been received from a medical assistant, concerning a 5-years-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On 05-APR-2022, the patient was vaccinated with improperly stored second dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U025790, expiration date: 19-AUG-2023 (exact dose, vaccination scheme frequency and anatomical location were not provided) administered subcutaneously for prophylaxis, after the vaccine underwent a temperature excursion of -14 degrees Celsius (C) up to -10 degrees C for 3 hours (h), 0 minutes (min) and 0 seconds (sec); -10 degrees C up to 8 degrees C for 1 h, 30 min, 0 sec on 23-MAR-2022 (Product storage error). No previous temperature excursion was reported. No additional adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA008004: US-009507513-2205USA007978: US-009507513-2205USA007982: US-009507513-2205USA008006: US-009507513-2205USA008105: US-009507513-2205USA007703: US-009507513-2205USA007704: US-009507513-2205USA007723: US-009507513-2205USA007809: US-009507513-2205USA007821: US-009507513-2205USA007852: US-009507513-2205USA007871: US-009507513-2205USA007957: US-009507513-2205USA008000: US-009507513-2205USA008002: US-009507513-2205USA008008: US-009507513-2205USA008028: US-009507513-2205USA008051: US-009507513-2205USA008066: US-009507513-2205USA008069: US-009507513-2205USA008100: US-009507513-2205USA008189: US-009507513-2205USA007739: US-009507513-2204USA009330:
1. Tingling and numbness to the teeth ? immediately after the vaccine (the feeling went away) 2. Tingling and numbness to the teeth, tongue, and lower jaw about 30 minutes after the vaccine (lasted for about 1 hour) 3. Experiencing residual (very mild) numbness to the lower jaw/teeth 17 hours after the vaccine
This case was received from a health professional on 09 November 2007. Seriousness Criteria: Other-Medically Significant A male patient in his early 40's, with a history of aortic dissection and aortic valve replacement, received an intramuscular left deltoid injection of Fluzone (lot number not reported). Approximately one week after vaccination, the patient developed left arm pain radiating to the left side of his neck. The pain became increasingly worse, and the patient was referred to an orthopedic doctor, who diagnosed him with Parsonage-Turner Syndrome. Treatment included pain medication and physical therapy twice a week. Concomitant medications included warfarin, and the reporter noted that the patient received annual flu vaccinations. At the time of the report, the patient had not yet recovered.
cannot see out right eye; Flu; Red right eye; Blurry vision from right eye; Soreness at injection site; This case was reported by a consumer via call center representative and described the occurrence of visual disturbance in a 63-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) for prophylaxis.   Previously administered products included Fluarix Quadrivalent with an associated reaction of ocular hyperaemia (for tolerance of 1st dose refer case US2020AMR002438).   On 23rd November 2019, the patient received the 2nd dose of Fluarix Quadrivalent 2019-2020 season (intramuscular). On 23rd November 2019, less than a day after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site pain. On 25th November 2019, the patient experienced eye red and blurred vision. On 28th November 2019, the patient experienced influenza. On 3rd January 2020, the patient experienced visual disturbance (serious criteria GSK medically significant). Rechallenge with Fluarix Quadrivalent 2019-2020 season was positive. On an unknown date, the outcome of the visual disturbance was unknown and the outcome of the influenza, eye red and blurred vision were recovering/resolving and the outcome of the injection site pain was resolved with sequelae.   The reporter considered the visual disturbance, influenza, injection site pain, eye red and blurred vision to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient had soreness at the injection site after receiving the vaccine. Two days later, the patient had redness and blurry vision in her right eye.  The patient also experienced flu. The patient reported that the eye redness and blurry vision had not resolved and the intensity fluctuated, sometimes it was better in the morning then the following day it got worse.  On the day of reporting the patient could not see out the right eye and was asking for how to manage with it. The patient had not fully recovered from the flu so far. The reporter consented to follow up.
probably 3/4 of the dose did go in. Some dripped down her (patient's) arm as I was injecting it with no adverse event; syringe cap and a tip cap. It seemed like it was leaking from underneath the syringe cap. The syringe cap seemed like it wasn't that tight with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via regulatory authority (Reference number- 00682181) and transmitted to Sanofi on 14-Jul-2021.  This case involved 19 year old female patient who administered probably 3/4 of the dose did go in and some dripped down her (patient's) arm as injecting it (underdose) due to syringe cap and a tip cap it seemed like it was leaking from underneath the syringe cap the syringe cap seemed like it wasn't that tight (device connection issue) while receiving RABIES (HDC) VACCINE [IMOVAX RABIES].  Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.   On 14-Jul-2021, the patient received 1 ml dose of suspect RABIES (HDC) VACCINE (lot: T1D851M and expiry date: 26-aug-2022) via intramuscular route in the left arm for product used for unknown indication  On 14-JUL-2021 the patient administered probably 3/4 of the dose did go in and some dripped down her (patient's) arm as injecting it (underdose) due to syringe cap and a tip cap it seemed like it was leaking from underneath the syringe cap the syringe cap seemed like it wasn't that tight (device connection issue) (latency: same day, non-serious events) following the administration of RABIES (HDC) VACCINE.  It was reported that, "When she administered it leaked out where the needle attached. She stated she spoke to someone Drug information that told her to repeat vaccine. The IMOVAX leaked during injection. Yes, this occurred today. I do not know how to describe it. Let me look at the picture. I was very careful with the instructions because this seemed more complex than the usual one. I held it by the cap, not by the plunger rod or the barrel. I felt like I did everything right. I can not say exactly where it was leaking, like if it was down towards the needle or up towards the syringe. Since we do have to re-administer the shot, I would like a replacement to the pharmacy. The IMOVAX has already been discarded in the sharps container".  This case was an actual medication error case (vaccine underdose and syringe connection issue)   At the time of reporting, no adverse event
MS diagnosis; Bounding heartbeat; Headache; Extreme fatigue; This case was reported by a consumer via call center representative and described the occurrence of multiple sclerosis in a 69-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced multiple sclerosis (serious criteria GSK medically significant), heart racing, headache and fatigue. On an unknown date, the outcome of the multiple sclerosis, heart racing and headache were unknown and the outcome of the fatigue was recovered/resolved.   It was unknown if the reporter considered the multiple sclerosis, heart racing, headache and fatigue to be related to Shingrix.  Additional details were provided as follows: It was reported that the patient received 1st dose 2 months ago and patient was now due for 2nd dose. The patient experienced bounding heartbeat and headache within 8 hours followed by extreme fatigue 2 days. The patient was also diagnosed with multiple sclerosis. The patient asked if the patient could receive 2nd dose.
Began with intense itching  at injection site on the evening of February 24th (one week after first vaccination). Quickly progressed to  hard, hot, red, swollen  and painful  area over top of arm,  continued itching, and stiffness.  It has been difficult to raise my left arm above shoulder level.  Somewhat better today (February 26th), but injection site still hot and hard, and stiffness in muscle still present.  Itching has subsided.
About 4 hours after vaccine a very large blood blister came up in the right side of my tongue.; busted blood blister and dentist checked area; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot Number EN6202) via an unspecified route of administration in arm left on 01Mar2021 13:00 as dose 2, single (age at vaccination: 67 years) for COVID-19 immunisation. Medical history included prinzmetal angina, thyroid, both from an unknown date and unknown if ongoing. Concomitant medications were not reported. Historical vaccine includes bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot Number EL9264) via an unspecified route of administration in arm left on 06Feb2021 11:30 AM as dose 1, single (age at vaccination: 67 years) for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No known allergies to medications, food, or other products. The most recent COVID-19 vaccine was administered at hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and the patient received other medications within 2 weeks of vaccination. On 01Mar2021, the patient experienced about 4 hours after vaccine a very large blood blister came up in the right side of my tongue, busted blood blister and dentist checked area. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Treatment was received for the adverse event. The clinical outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Vaccine given was invalid due to exposure to out-of-range temperatures during transport.  Manufacturer, CDC, and medical director recommended revaccination.
Follow up to FAERS18694343: Patient received casirivimeb instead of intended COVID vaccine. 48-hr follow up revealed arm soreness Patient received COVID vaccine December 31
On 10/22/09 at 12:30 HA present (vice-like grip on eyes and around head). Contacted provider via phone-placed on MEDROL dose pack-would become nauseated if sitting up from lying position-daily thru 10/26/09 HA decreased on 10/27/09 slight pressure behind eyes otherwise no other s/s.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 07-APR-2014, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 05-AUG-2016, the patient was treated by a physician for the onset of a vesicular rash, which was diagnosed as herpes zoster. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.
SEVERE MUSCLE WEAKNESS.  PATIENT FELL UPON RETURNING HOME BECAUSE HIS LEGS GAVE OUT.
temporary memory loss; This spontaneous case was reported by an other health care professional and describes the occurrence of AMNESIA (temporary memory loss) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AMNESIA (temporary memory loss). At the time of the report, AMNESIA (temporary memory loss) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.
pain at injection site; difficulty lifting left arm where  vaccine administered Narrative:  going to see her pcp today for further  evaluation  Other Relevant History:
pt recvd vax 6OCT93 & 2 days later pt exp nausea; fever; aching joints; swollen lymph nodes of the lt neck; red, burning eyes; h/a & resp distress; pt presented to ER;
experienced a full day of rapid heart beats; difficulty speaking; pain in back near the liver; fever that comes and goes; headaches in the mornings and evenings; weakness; diarrhea; fatigue; muscle pain; joint pain; chills; nausea; vomiting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHENIA (weakness), DIARRHOEA (diarrhea), HEART RATE INCREASED (experienced a full day of rapid heart beats), SPEECH DISORDER (difficulty speaking) and PAIN (pain in back near the liver) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hepatitis C. Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included UPADACITINIB (RINVOQ), PREDNISONE and CELECOXIB (CELEBREX) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced ASTHENIA (weakness), DIARRHOEA (diarrhea), FATIGUE (fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (nausea), VOMITING (vomiting) and HEADACHE (headaches in the mornings and evenings). On an unknown date, the patient experienced HEART RATE INCREASED (experienced a full day of rapid heart beats), SPEECH DISORDER (difficulty speaking), PAIN (pain in back near the liver) and PYREXIA (fever that comes and goes). At the time of the report, ASTHENIA (weakness), DIARRHOEA (diarrhea), HEART RATE INCREASED (experienced a full day of rapid heart beats), SPEECH DISORDER (difficulty speaking), PAIN (pain in back near the liver), FATIGUE (fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (nausea), VOMITING (vomiting), PYREXIA (fever that comes and goes) and HEADACHE (headaches in the mornings and evenings) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported.
11/19: Marked swelling, erythema elbow to shoulder to left side of face.  Went to ER, shot given left deltoid.  Prescribed Keflex 250 two times a day for 7 days and Benadryl every 6 hours.  Seen follow up office 11/21/2003.  Decreased redness, swelling, right eye with Rordeola, recovering.
Information has been received from a registered pharmacist concerning a 63 year old female who was vaccinated with ZOSTAVAX (Merck) and experienced shingles after vaccination. The patient told the pharmacist that the vaccine didn't work on her. At the time of reporting, the outcome of the patient was unknown. Additional information has been requested.
This spontaneous report was received from a pharmacist referring to patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 17-APR-2016, the patient was vaccinated with improperly stored dose of VARIVAX (Merck) lot #: L018001, expiration date on 19-MAY-2017 (dose, route and anatomical location were not reported). Concomitant therapies were not provided. The vaccine was stored in a temperature of 43F during 68 hours. No previous temperature excursion was reported. No adverse events were reported. Additional information is not expected, since no consent to contact the reporter was provided.
I have been going back between sweat. Chills severe nauseous. Fatigue  and headache
Deltoid soreness; This is a spontaneous report from a contactable pharmacist (patient himself). A 54-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration in left arm on 04Feb2021 10:00 AM at single dose for COVID-19 immunization in facility type of other. The patient's medical history included COVID-19 (the patient was diagnosed with COVID-19 prior to vaccination). Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not been tested for COVID-19 since the vaccination. On 05Feb2021 05:00 AM, the patient experienced deltoid soreness. The event was considered as non-serious by the pharmacist. No treatment was received for the adverse event. The outcome of the event was recovering.
Soreness, red circles on skin size of quarters developing into solid area about 2X3" to lower right of injection site
pt recv vax; exp high fever,redness,joint pain,knots behind ears,rash & sleeping & waking herself up w/ her own loud noises;weigh gain,chronic arthritis pain,unsteadiness,memory problems,depression,high blood pressure;ASA for pain;
Next evening had trouble lifting arm because of pain. Pain on touching not on vaccine site but lower up to elbow. Area was red, warm and swollen. Vaccine administered on 3/5, now it is 3/9 and I am able to move arm with no pain only sore when I touch area between shoulder and elbow. I have had one lymph node removed on that arm, could it have caused the reaction? I have never had any adverse reactions before with vaccines.
Unilateral carpal tunnel syndrome; Pain; Chills; This spontaneous case was reported by a consumer and describes the occurrence of CARPAL TUNNEL SYNDROME (Unilateral carpal tunnel syndrome), PAIN (Pain) and CHILLS (Chills) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On an unknown date, the patient experienced CARPAL TUNNEL SYNDROME (Unilateral carpal tunnel syndrome), PAIN (Pain) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and NAPROXEN at an unspecified dose and frequency. At the time of the report, CARPAL TUNNEL SYNDROME (Unilateral carpal tunnel syndrome) was resolving and PAIN (Pain) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of carpal tunnel on hand, aches pains chills due to vaccine unknown onset and aches pains chills due to vaccine unknown onset with humira(adalimumab) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Left arm - from shoulder to elbow red, swollen, warm to touch, tender, 3 in wide by 6 in long.
03/08/2019 Epsom Salt Bath before bed 03/09/2019 NOTICEABLE swelling in thigh around injection sight.  injection sight red, firm and warm to touch being about 2-3 inches diameter.  Diameter of swelling in thigh with redness was at least 5 inches in diameter.  Treatment included Tylenol or Ibuprofen for swelling followed by children's benydral.  Upon taking benydral signs of decreased swelling took place within 24 hours.  Two days after no pain reliever but continued with allergy medication.  Normal thigh size (or no swelling) took the course of about a week and a half.
Pt recvd vax in 1992 & 3 days p/vax pt did not feel well, devel a vision loss, & was hospitalized; dx w/viral meningitis; addtl details are being requested;
The pt was seen on 10/03/01 for exam. She was well and was given Pneumovax and flu vaccine, both in the right shoulder. She then developed fever up to 102.4F on 10/5/01, had sweats, chills and a headache. She also had erythema and pain in the left shoulder.
Pt recv vax & next day exp V&D. 2 days later V stopped but D persisted.No further information.
incorrect product storage; No additional adverse effects reported; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 30-DEC-2020, the patient was vaccinated with improperly stored hepatitis b vaccine (recombinant)(RECOMBIVAX HB) lot# R028529, expiration date 09-JUN-2021 (formulation, strength, dose and route of administration were not reported) for prophylaxis.  The administered doses of the vaccines were stored with the lowest temperature of 34.3 Fahrenheit during 4 hours. There was a digital data logger involved, but there was no previous temperature excursion. No additional adverse effects were reported.  This is one of several reports received from the same reporter. Additional information is not expected.
I exp pain immediately following on injection site, fingers tingling on left side and couldn't lift laterally. The pain felt on scale of 1-10 a 10 also exp dizziness. 114/68 around 4:30pm I couldn't utilize left arm at all. When I got home around 8pm spouse had to assist in showering still felt dizzy. I tried to go to sleep was awoken by the pain couldn't sleep on left side. The next day felt exhausted and still in pain took Tylenol every 6 hrs. On day 3 the pain start to improve had movement left arm. My(estimated date of delivery 6/1/2021).
Dose of vaccine leaked out  which was more than 1/2 of the dose. Second full dose administered in the other arm, same lot number.
Fever and Chills, joint pain and rash on the torso. My husband had the shot the same day and broke out with a rash at the same time as me, but did not get sick. He had the same rash pattern: Left nipple a few spots then across the back and a few spots on the stomach. My rash is much MUCH, worse and developed into pustules. I had to go on an anti-viral medication : Valacyclovir. I still don't feel well and it's been five days. After starting on the Valacyclovir the joint pain and fever left in 24 hours but the rash continued to spread. I asked the technician if I should get this shot since I have RA and Leukemia. He said I couldn't get sick because it's not a "live vaccine".