chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reported redness surrounding the area of the pneumococcal vaccination on the right arm. In the same arm she reports weakness that has gotten better over the last 2 days. Additionally she is experiencing fatigue and loss of appetite secondary to nausea. She is taken Tylenol 1-2 tablets per day to control symptoms. She has not checked her temperature but says she does not feel like she is running a fever.
4 patients inadvertently received a 3rd Moderna Monovalent dose instead of the Bivalent dose; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (4 patients inadvertently received a 3rd Moderna Monovalent dose instead of the Bivalent dose) and NO ADVERSE EVENT (no adverse event) in a 4-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1417B) for COVID-19 prophylaxis.     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 WRONG PRODUCT ADMINISTERED (4 patients inadvertently received a 3rd Moderna Monovalent dose instead of the Bivalent dose) and NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (4 patients inadvertently received a 3rd Moderna Monovalent dose instead of the Bivalent dose) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (4 patients inadvertently received a 3rd Moderna Monovalent dose instead of the Bivalent dose).    It was reported that 4 patients inadvertently received a 3rd Moderna Monovalent dose instead of the Bivalent dose. No concomitant medication were reported. No treatment medication were reported.
error that occurred at my organization involving the administration of PROQUAD (MMR V) vaccine to a 17 year old patient; No additional AE; This spontaneous report was received from an educator via company representative referring to a 17-year-old patient of unkno gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication.  On an unknown date, at the reporter's organization the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). Other suspect therapies included sterile diluent (dose, route of administration, anatomical location, lot number and expiration date were not reported) (product administered to patient of inappropriate age).   It was also mentioned that the clinic leadership and provider were not sure what follow up was needed or if there were any health concerned, they should be aware of due to this error. No additional adverse events were reported.
This case was reported by a lawyer and described the occurrence of neurological damage in a male subject who was vaccinated with hepatitis B vaccine (Engerix B) and or unidentified hep B vaccine for prophylaxis. On an unspecified date the subject received unspecified dose of hep B vaccine. According to the legal complaint, at an unspecified time after vaccination with hepatitis B vaccine, the subject experienced "neurological damage" which was attributed to "cumulative mercury toxicity". The following information was received via medical records. The subject was vaccinated with hep B vaccine, manufacturer unspecified, on 11/4/1992, 8/11/1993, 7/13/1994. The subject was vaccinated with DPTa manufacturer on 09/25/1992, 2/18/1993, and 7/14/1994, and Dtpa on 5/4/1993. The subject was also vaccinated with live attenuated oral poliomyelitis vaccine, Hib, and MMR for prophylaxis. The subject reportedly developed normally until approx two years of age. IN Aug 1995, the subject was diagnosed with a developmental delay, suspect global delay. He was not speaking at that time, and exhibited frustration by tantrums. In Nov 1995, the subject underwent a comprehensive evaluation and demonstrated behaviors consistent with autism including temper tantrums with routine changes, perseveration on fine motor manipulative, abnormal emotional reactions, and failure to communicate normally. He was diagnosed with autism and mental retardation. He was enrolled in a special education program which included speech therapy. On 2/3/1997 the subject was examined for primary concerns of difficult behavior including hitting, throwing things, tantruming, kicking, hitting, and thrashing his body on the floor. On 12/24/1998, previous treatment with Prozac was replaced with Luvox. Upon examination on 2/19/99, the pt was described as restless, irritable, mute not communicating, and was engaging in attention seeking behavior. No physical abnormalities were noted. An updated psychological examination in March 1999 showed overall cognitive function that remained in the mentally deficient range. He continued to exhibit moderately serious behavior problems and maladaptations, including socially inappropriate behaviors within a school setting. This case was assessed to be medically significant by manufacturer (OMIC).
Numbness, heaviness in left arm, tightness in chest. Induration at injection site.
Fever 37.2, depression, nausea, weakness, high blood pressure, headache, absence of appetite, sweating, drowsiness since the next day after the first shot.
Employee describes her bicep "blowing up" (i.e. being swollen) post vaccination. Denies deltoid swelling. During her shift, she started feeling run down; went home to sleep. When she woke up, reports feeling her throat "felt odd." Her voice was hoarse and her uvula was visibly swollen. When she returned to work for her scheduled shift, her co-workers confirmed visual swelling. She sipped ice water all day and swelling never advanced. No c/o respiratory issues. No medical intervention.
Was so sick for 12 hours; It was like a train ran him over but then ended right away; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Was so sick for 12 hours) and FEELING ABNORMAL (It was like a train ran him over but then ended right away) in a male patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Was so sick for 12 hours) and FEELING ABNORMAL (It was like a train ran him over but then ended right away). At the time of the report, ILLNESS (Was so sick for 12 hours) and FEELING ABNORMAL (It was like a train ran him over but then ended right away) outcome was unknown.            No concomitant medication was reported by the reporter. No treatment information was provided.
No other adverse events reported; Seven doses of improperly stored GARDASIL 9 were administered to 7 different patients; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications past drug reaction or allergies were not reported.  On 07-JAN-2022, the patient was vaccinated with one (1) improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dosage, vaccination scheme frequency, route of administration and anatomical site of application were not reported; lot number T039467 that was verified to be a valid lot number for syringe formulation with an expiration date reported and established as 20-MAY-2023) for prophylaxis (product storage error).   The vaccine previously underwent a temperature excursion of 33.4 degrees Fahrenheit (F) for 2595 hours. There was no previous temperature excursion. No further information provided.   No other adverse events were reported (no adverse event).  This is one of seven reports received from the same reporter. ; Sender's Comments:  US-009507513-2203USA007825: US-009507513-2203USA007997: US-009507513-2203USA008097:
developed diffuse brachial plexopathy involving mainly medial lateral and posterior cord brachial plexus. Thought to be 2hours to tetanus injection. Resolved 95% on  o3/01/2005
pt recvd vax & w/in 45mins p/vax exp vomiting, fever, h/a, flushing, joint pain, dizziness, & elevated BP;
Patient developed acute ataxia, which was treated with Benadryl and one dose of Decadron.  Symptoms resolved within 24 hours.
Information has been received from a registered nurse concerning a 17 year old white female nurse's aid who on 20-FEB-2007 was vaccinated with Gardasil (Lot 654702/0011U).  On 20-FEB-2007 the patient experienced malaise, slight fever and vomited x2 later that day.  The patient went to bed and on 21-FEB-2007, she had recovered from malaise, slight fever and vomiting.  On 23-APR-2007, the patient received her second dose of Gardasil (Lot 657622/0388U) and had no adverse effects.  Additional information is not expected.
Where the shot was is a small red spot & does itch some.  Around where the tape was put for the shot has a little red.  About 24 hours.
Patient became lightheaded, pale, and unresponsive for approx. 1 minute. BP 90/48. Placed on couch w/ feet elevated. Given apple juice after alert & oriented x3. BP 98/60 prior to leaving office.
2 day hx of fever T101, irritable, lethargic, poor feeding;resp failure &pneumonia dx w/ initial meningo-encephalitis picture;recovered; later had persistent paralysis but is socially appropriate for age; dx:paralytic meningoencephalitis?
At 330 am I got the chills and could not go back to sleep, after an hour went back to sleep  around 530 am  started running a fever of 100.3 and had a severe headache and body aches. Fever went down with tylenol,  but had headache all day.  Fever did come back later in the day resolved with Tylenol. Next day fine  but did have cold sores inside mouth .  Head ache on 1/8 no fever or anything.
fever of 103 degree F after her 1st dose; This is a spontaneous report from a contactable consumer (parent). A 17-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Patient medical history, concomitant medication or past drug reaction were not reported. On an unspecified date, after first dose of vaccination, patient experienced a high fever of 103-degree F which lasted about 48-72 hours before patient got back to her normal self. Reporter asked if this was normal for her daughter as everyone in their family (blood related) got the vaccine but only her daughter had these effects. Outcome of the event was resolved on an unspecified date.  Information on the lot/batch number has been requested
EXACTLY 15 MINUTES AFTER THE VACCINE ADMINISTRATION WHEN I FELT LIKE MY THROAT IS CLOSING UP LIKE I CAN'T SWALLOW THEN I FELT MY HR IS BEATING FAST THEN MY FEET AND MY LEFT SIDE OF THE BODY FELT COLD. THAT'S WHEN I RAISED MY HAND AND CALLED FOR HELP. THEY IMMEDIATELY CAME AND ASSESSED ME. THEY PUT MY HEAD DOWN, GAVE ME 02 WITH 2L/MIN AND WET TOWEL ON MY FOREHEAD. THE INITAL BP WAS ABOUT 158/90 111 PER THE MCS. AFTER 20-30 MINUTES OF MONITORING MY SYMPTOMS STARTED TO GET BETTER, THEY TRIED TO SIT ME UP SO I CAN TAKE BENADRYL BUT I FELT DIZZY. SO THEY PUT BACK MY HEAD DOWN AND CALLED 911. TOOK 50 MG OF BENADRYL AND LATER SENT HOME BY PARAMEDICS.
pt recv vax that same day pt devel swelling, soreness & redness @ inj site;it was reported that pt was not pregnant but wants to get pregnant & MD did not explain the pregnancy contraindications to pt;
Vaccinee was in 15 min observation area and just before that time was up, she called for the Nurses because she "was feeling lightheaded and her hands were tingling".  She was talking but seemed alarmed. Lungs were clear BP was 148/98 which is high for her.  EMS on site and called over to respond. They transported her to hospital and en route gave Epi and Bendaryl IM, she was further treated at the ER.   She was discharged home at about 6pm.
Information has been received from a physician concerning a 29 year old female, with no medical history and no allergies, who on 30-OCT-2007 was vaccinated with a dose of RECOMBIVAX HB. There was no concomitant medication. Two days after the patient received RECOMBIVAX HB, on 01-NOV-2007, the patient broke out with a diffuse rash, on both arms. The physician considered the patient's rash to be related to vaccination with RECOMBIVAX HB. On 08-NOV-2007 the rash was described as in the antecubital area of both arms and slightly better than when the rash started. At the time of the report the patient was recovering. It was reported that the patient went to the physician for follow-up. There were no laboratory or diagnostic tests performed. No product quality complaint was involved. No other information was provided. Additional information has been requested.
It started with arm tenderness at the injection site on Thursday night 10/28/2021. The morning of 10/29/2021 I woke up with a pounding headache. During the course of the day, I took one Ibuprofen for the headache, and I took the day off of work because the headache did not get any better. I took a nap. When I woke up my arm was very swollen and started to get very red. It felt like it was tight. Like if someone put on a blood pressure pump. It was later evening now and I decided to take my temperature. I did not have a fever. I had no pain. No headache. I decided to wait until Saturday morning. I took a sharpie and marked the swollen spot on my arm. On Saturday morning I was volunteering at a vaccination site, and I asked an ENT to take a look. They recommended me to talk to my PCP. I spoke with a physician on call, and they suggested me to go to urgent care. I went in and the doctor was uncertain if this was cellulitis or an inflammatory immune response. She decided to treat it with Keflex. She did feel it was more an inflammatory immune response. The swelling started to go down the next day. On Tuesday, the swelling and redness completely dissipated.
6hrs post vax pt had questionable sz activity including deviation of the eyes backwards, limpness x 1-2 min;  no temp noted
Patient reported severe arm swelling and redness the size of a large orange after receiving Tetanus vaccine (she's not sure which specific one it was) at the hospital a week prior, she was given antibiotics from her doctor for it. Patient was at the hospital in the first place for falling, and received the vaccine during her hospital stay.  She noticed a large lump the day after she received it, and it grew in swelling and redness to the circular size (not 3d) of about a large orange which was still that large a week later. She just had a prescription for antibiotics filled due to concerns of an infection.
Vaccine received age 14; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of OFF LABEL USE (Vaccine received age 14) in a 14-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (Vaccine received age 14). At the time of the report, OFF LABEL USE (Vaccine received age 14) outcome was unknown.        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.
Fever, chills, body aches, nausea, vomiting, extreme fatigue and fainting at 12am. I now have extreme jaw pain.
Had vaccination Friday afternoon on Saturday had symptoms of nausea & vomiting, also extreme soreness/ achiness of muscles also soreness of bones of vertebrae down to ankles still sore as of Monday.
First hands are numb.  Then legs are extremely weak and it is hard to walk,  they are very unstable.  When I cough or sneeze,  I have shooting electric type pain through my arms and across my chest.  This has  been consistent since right after my first shot.  Doctors are saying that it is only arthritis.  They have run blood work and xrays.  But symptoms continue to affect me and I am unable to work due to severity.
Headache; This is a spontaneous report obtained from a contactable nurse through a Pfizer sales representative.  A 17-years-old male patient received meningococcal group b rlp2086 (TRUMENBA) on an unspecified date, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, after the vaccination the patient experienced headache that was so severe that the patient went to the emergency room (ER). Clinical outcome of the adverse event was unknown at time of this report.   The information on the lot number has been requested.
terrified; pain; feels like its an open wound on his right thigh; stomach has an egg; First shot on 13Aug2021, Second shot on 03Sep2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First shot on 13Aug2021, Second shot on 03Sep2021), FEAR (terrified), PAIN (pain), LIMB DISCOMFORT (feels like its an open wound on his right thigh) and INGUINAL MASS (stomach has an egg) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. FD0A09 and 1775978. FC3180) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure.   On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First shot on 13Aug2021, Second shot on 03Sep2021). On an unknown date, the patient experienced FEAR (terrified), PAIN (pain), LIMB DISCOMFORT (feels like its an open wound on his right thigh) and INGUINAL MASS (stomach has an egg). On 03-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First shot on 13Aug2021, Second shot on 03Sep2021) had resolved. At the time of the report, FEAR (terrified), PAIN (pain), LIMB DISCOMFORT (feels like its an open wound on his right thigh) and INGUINAL MASS (stomach has an egg) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included blood pressure medications. Treatment medication stated Aleve and cold compresses which was used for events related to Dose 1 and also include t already went to ER and his doctor and had an X-ray and sonogram and an MRI but they found nothin in there. Said that he will be seeing his doctor tomorrow morning and  ask for a pain killer and antibiotic.   This case was linked to MOD-2021-368988 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-Oct-2021: Significant follow-up appended include events added.
Red, blistered, itchy spots all over body, elevated temperature, diagnosis chicken pox.
Beginning 2/2/2021 I developed swollen, painful lymph nodes under my right arm and near the right side of my clavicle. I had visible swelling surrounding my right armpit. I felt fatigued and unwell, like I was sick.
HAD A SEIZURE THE NEXT DAY, NOT SURE IF RELATED...HAS HAD SEIZURES IN PAST AND HAD HAD A MIGRAINE AND LUNCH WAS VERY LATE
First day;   A little sore arm.  In the evening had periodic spasms of extreme pain in hand and fingers.      Second day:   Upper arm down to elbow more painful,  But pain in hands and fingers completely gone. But that night after undressing, I had swelling, warmth and redness traveling down my upper arm in a diagonal 2 inch line.     Third day:   The swelling and redness had subsided, but still there a little in the morning.  I could also see where it had traveled more down my arm in the night.   Pain is almost gone.  Fourth day:  Arm is still a little sore, but otherwise I feel ok.
Initial report received from a healthcare professional on 08 OCTOBER 2014. This case is part of cluster of two cases and is linked to case number 2014SA154599. 4 patients had received a dose of FLUZONE QIV (batch number UI188AA, dose in series and site of vaccination not reported) intramuscularly on an unspecified date. The patient had no illness at time of vaccination and had no known allergies. On an unspecified date, after receiving the vaccine, the patients developed site reactions with swelling, redness and heat. The patient also experienced dizziness, nausea, vomiting and chills within 12 hours. Laboratory investigations were not performed. The patient was advised to apply ice and take BENADRYL prn (as needed). At the time of this report, the patient outcome was unknown. Documents held by sender: none.
Pt had multiple vaccines 3/30 (typhoid, H1N1 injectable, TDAP, Anthrax, IPV) and received Yellow Fever on 3/31.  Evening of 3/31 reports myalgias, clammy feeling and noticed rash on right forearm.  On 4/1 rash was mild but on 4/2 rash extended to both arms and across back and chest.  Pt saw provider 4/2 and was given.
PT PRESENTED WITH HYPERVENTILATION, TINGLING AND BENIGN TREMORS  IN  HANDS AND FEET. TACHYCARDIA, NAUSEA. VITALS:  BP 126/85 AND 132/78; REPEAT 102/68 AND 112/68 AT 2:58 HR 97 RR 20 O2 98% THE ABOVE CONDITIONS RESOLVED ON THEIR OWN WITHOUT MEDICATION GIVEN. PT DRUNK GATORADE AND STATED THAT SHE FELT BETTER. AFTER 10 MINUTES OF OBSERVATION, SHE LEFT WITH HER HUSBAND DRIVING THE CAR.
I had pretty bad nausea. I contacted a doctor online. I was prescribed some medication. The nausea went away after about 2 days. That was followed by paresthesia, which was tingling sensation in different areas of my body. I still have tingling in my back and groin area. I let the doctor know about that but they did not have any treatment for that. I have sparks of pain in different areas. They did not have any treatment for that either.  I went to my cardiologist because I had a little bit of fluttering in my heart, this was before the vaccine. They did an echocardiogram, and it came back normal. I am supposed to go back for some additional tests. I also had insomnia the first night of the vaccine. I had some of the sparks of pain in my chest area and that lasted for about a week and it was not a continuous pain. The tingling sensation has not gone away.