chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse refers to an unspecified number of patients of an unknown age and gender. The patients concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with improperly stored PROQUAD (Merck) (Lot # L023111, expiry date 24-DEC-2016). No adverse events reported. This is one of the two reports received from same reporter. Additional information has been requested.
The patient developed swelling, redness and pain at injection site-inner biceps of the left arm; The patient developed swelling, redness and pain at injection site-inner biceps of the left arm; The patient developed swelling, redness and pain at injection site-inner biceps of the left arm; This spontaneous report was received form a nurse and referring to a 69-year-old female patient. The information about the patient's concurrent conditions, concomitant therapies, historical drugs, drug reactions or allergies, or medical history provided was unknown by the reporter.  On 29-MAY-2019, the patient was vaccinated with 1 dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 milliliter, intramuscularly in the left deltoid, lot # R025296, expiration date 08-JUN-2020 (strength was not reported) for prophylaxis.        On 30-MAY-2019 in the afternoon, the patient experienced swelling, redness and pain at the injection site, also reported as the inner biceps of the left arm.   On 31-MAY-2019, the patient sought for medical attention in order to report the adverse events.   The outcome of the aforementioned events was recovered at the reporting time.   Furthermore, it was unknown by the reporter if any laboratory diagnostics or studies were performed.   The causal relationship between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the events was unknown.
Pt recv vax on 11/3/98; on same day pt exp sore, irritated, swollen, inflamed rt arm, rash, hot to touch
This spontaneous report as received from a registered nurse refers to an 18 months old patient. The patient was vaccinated with the first and only dose of live, oral, ROTATEQ (lot number not provided) oral on 28-SEP-2012 when the patient was "one year and six months old". No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Moderna Covid19 Vaccine EUA: About 12 until 36 hours after shot; slight fever; strong headache; sore injection site arm; elevated heart rate; insomnia.
diarrhea -- same day, resolved within 24 hours injection sight pain -- pain was much more than a typical shot, felt like a tendon injury by the end of the day, pain impacted mobility.  Completely resolved over night.
Pt describes feeling unwell that night, nausea and vomiting next day, general body aches, hypothermic, 3 days later seen in ED, hypotension, septic shock, and DKA/AKI. Also noted to have mild prominence of right oropharyngeal well with normal epiglottis and larynx on CT. There is noted uvular edema of unknown etiology
Patient received vaccine on 8/12/2020, the following morning noticed an irritating lump in her arm pit of her left arm, painful if pressed upon. This lump remained present for roughly 3 days and then went away completely. She did not need to take anything to treat the lump. She reports no other side effects
left arm felt numb all the way down to the fingers.  Next day, thumb, forefinger and middle finger still numb from the knuckle to finger tip.  Today, on day 8, still numb on foreginger and middle finger from the knuckle (middle of finger) to the fingertip. At night it darts up to the elbow.
mixed reconstituted dtap/IPV with normal saline that is used to reconstitute other medications with no AE; Initial information received on 06-Jan-2021 regarding an unsolicited valid non-serious case received from other health professional.  This case involved a 1 year old male patient who received a 0.5 ml dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number and expiry date not reported), via unknown route at right thigh, on 05-Jan-2021 (Wrong technique in product usage process).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  It was an actual medication error due mixed reconstituted dtap/ipv with normal saline that is used to reconstitute other medications (Wrong technique in product usage process) on same day.    At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Left leg parasthesias...pain, craming, heaviness and numbness.  Improved over next 4 hours but mild tingling and numbness persists.
Pain in neck . unable to move .Very stiff. Now I have nerve pain in arm. Unable to stop pain. burning throbbing pain.
Feeling of warm wave, then very shaky.  EMT?s reported BP 190 and heart rate 156.  By evening the site was very painful with a swollen red welt. Redness has lasted over a week. Pain gone after 6 days. Stared itching 2 days after injection.
the patient inadvertently received a dose of PROQUAD and a dose of VARIVAX at the same office visit.; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      On 14-SEP-2020, the patient was inadvertently received a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot #: T006838, expiration date: 24-AUG-2021; route and dose details were unknown) and a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot #: S021322, expiration date: 09-JUL-2021; route and dose details were unknown) for prophylaxis at the same office visit (inappropriate schedule of product administration).
About a week later an itchy rash appeared on my arm at injection site. In addition, the soles of my feet became itchy along with a few minor spots on either both hands. All reminiscent of bug bites. By far the biggest cluster was around the place of injection.
pt recv vax 15JAN96&devel several sl pruritic erythematous macular like skin lesions w/darkened ctr on stomach,upper back&shoulder;region also had some pain;
10/18/12 - Woke up with rash - covered all over body. Seen in ER dx contact dermatitis, PRELONE Rx given.
While driving home today, 5/7, one day after 2nd dose administered pt began to have blurry vision.  Husband was driving.  All of a sudden pt was looking out the window and things were very blurry.  No other symptoms noted at the time.  No Tx.  at 12pm pt states vision is a little blurry but not as bad.
Migraine like headache (Approx 4+ hours) Noticeable deep heartbeat (several hours Chills (2 hours +)
Patient was nervous about getting the vaccine. Patient felt dizzy as she stood up and started to faint. Her mother and I caught her to lower her to the ground and she came back out of it before we even got her to the ground. She became pale and sweaty.
Protocol for Moderna vaccine is 18 years and older.  Patient was only 17. Attempted to contact without luck and will try again.
After the second dose she had immediate pain at the injection site and over the next 24 hours she developed: A fever of 101.4 severe abdominal pain and chest pain that made her feel like her heart was being pulled out painful electric shocks down her neck and spine that made her walk hunched over numbness and swelling in the arm she got the shot pain in her fingers and toes that turned white and were ice cold to the touch  Over the next 2.5 months her abdominal, muscle and nerve pain became unbearable plus she developed new symptoms:  Fatigue gastroparesis, nausea and vomiting Eventually she couldn?t even swallow food or liquids without immediately spitting it up. An itchy rash on her arms  peeling skin on her feet Her menstrual cycle lasted a month with large clumps of blood   She had unexplained painful cysts vision problems headaches erratic blood pressure and heart rate memory loss, mixing up words and brain fog Dizziness, fainting and then nonepileptic seizures that we suspect were from lyrica verbal and motor tics loss of feeling from the waist down, muscle weakness, abnormal gait and eventually she wasn?t able to walk at all urinary retention  From the day she got her 2nd dose to today we took her to the ER nine (9) times and she was admitted to the hospital a total of 3 times totalling 2 months. The last time she was admitted to the hospital she could not walk, was unable to feel or move below her waist,  threw up anything she tried to eat or drink, had tachycardia and her blood sugar was at 47.  Once she got an NG tube and was stable they transferred her to Inpatient Rehabilitation and she was just discharged on June 1st. Today she is able to walk with a walker and take care of herself but she still has little to no feeling below her waist.  She still has an NG tube for nutrition and continues to have GI and urinary retention problems.
This spontaneous report was received from a licensed practical nurse refers to a 15 week old male patient. On approximately 10-JUL-2012, the patient was vaccinated with the first dose of ROTATEQ (lot # not reported) which was taken orally (dose 1 tube). No concomitant medications were reported. No adverse effect has been observed or reported. The nurse had informed her representative who had told her that she would take care of reporting the administration of ROTATEQ vaccine outside of the Prescribing Information (PI). Additional information has been requested.
Pt. Was given 1st GARDASIL shot today. Pt. passed out after feeling faint and sick to stomach. Pt. was pale but opened eyes and was alert after Ammonia salts.
Information has been received from a licensed practical nurse concerning a 22 year old female who on 15-JAN-2007 was vaccinated with a first dose of Gardasil (lot # 654741/1208F) 0.5 ml IM. On an unspecified date, the patient was vaccinated with a second dose of Gardasil (lot # 656049/0187U) 0.5 ml IM. On 17-AUG-2007, the patient was vaccinated with the third dose of Gardasil (lot # 658222/0927U) 0.5 ml. IM. Concomitant therapy included hormonal contraceptives (unspecified). On 13-OCT-2007 and 29-DEC-2007, the patient experienced a seizures. On an unspecified date, the patient was seen at the emergency room. The patient was not hospitalized. The outcome of the seizures was not reported. Upon internal review, seizure was considered to be an Other Important Medical Event. Additional information has been requested.
Arm and hand swollen; Joints, knuckles hurt a little bit; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm and hand swollen) and ARTHRALGIA (Joints, knuckles hurt a little bit) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-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 PERIPHERAL SWELLING (Arm and hand swollen) and ARTHRALGIA (Joints, knuckles hurt a little bit). At the time of the report, PERIPHERAL SWELLING (Arm and hand swollen) had not resolved and ARTHRALGIA (Joints, knuckles hurt a little bit) 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.   No concomitant and treatment medication was not provided   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up received and significant information, outcome of the event swollen from unknown to not recovered/not resolved
55 year old female was administered Fluzone High Dose, no adverse event; 55 year old female was administered Fluzone High Dose, no adverse event; Initial information received on 21-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 55 years old female patient who was vaccinated with a 0.5 ml dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot: UJ285AA, expiry date: 02-Jun-2020), via unknown route in the right arm, on 21-Oct-2019.  The patient past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to inappropriate age at vaccine administration and it was a case of overdose.   At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
69 yr old female felt dizzy and lightheaded in observation area. Pt was moved to medical room and bp was taken and in the 190?s systolic. Pt has a bump on the injection site of her arm with some tenderness. Pt stated her bp has been high and pt is on a new blood pressure Med she didn?t know the same to. Pt rested for over 30 minutes and bp reduced to 180?s  systolic. Pt states she gets dizzy when she gets high blood pressure reactions and she is due for her meds now and forgot them at home.  Pt states her husband will bring her home to take her meds and she?ll see how she feels . If she feels worse she?ll go to the hospital . Pt also states she will see her primary doctor to have her meds adjusted since she is on the lowest dose. Pt lump on her injection site was decreased and pt signed a release to be let back into the observation area where she checked out.
TOOK THREE DOSES OF EXPIRED VIVOTIF; This spontaneous case report was received from a nurse (PVX2019-149) on 16-Jan-2019. The report describes a 41-year-old adult male consumer who "took three doses of expired Vivotif". The consumer was receiving Vivotif (lot number: 3003202 and expire date: Nov 2018) for an unknown indication.  It was reported that the consumer took three expired doses of Vivotif.   The action taken with Vivotif with respect to the event "took three doses of expired Vivotif" was not applicable.  The clinical outcome of the event "took three doses of expired Vivotif" was unknown.  Company's Comment: The causality of the event "took three doses of expired Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took three doses of expired Vivotif" was considered as not applicable.
Severe pain, swelling, redness to left deltoid/shoulder area.  Vaccine given 5/13/19.  Seen in office 5/15/19 with Dr.  Toradol given for pain.  Naproxen script given.
I was sleeping and was woken by violent Seizures a few hours after the vaccination. I was almost thrown out of bed. I don't know how long the seizures lasted as I had no awareness. (Imagine those films where someone turns into a Werewolf and their whole body and limbs strongly crack and convulse.) When it subsided I was so shocked and horrified, nothing like this has ever happened to me before. I took a warm shower to get my blood flowing. I went to my Doctor first thing the next morning so that he do a blood test  and report it. He scoffed scornfully at me saying "It can't have been the vaccination- it must have been something else!" Unknown iExcruciating severe Diaphragm muscle spasms, tests by an Orthopaedist,
Information has been received from a consumer concerning her son who on an unspecified date was vaccinated with MMR II (lot number 663877/0356Y, per OMC vaccine lot expiration 19-MAR-2011). The patient "was damaged" after getting the vaccination. The adverse event was happened a while ago. No further information is available.
PATIENT RECEIVED DOSE #2 TOO EARLY. RECEIVED DOSE #1 ON 2/24/21 AND SECOND DOSE ON 3/5/21. PATIENT REPORTS NO ILL EFFECTS. CDC DOES NOT REQUIRE ANY MORE DOSES. PATIENTS NOTIFIED.
May 2021 One week after the second and final dose of Pfizer: My heart was fluttering irregularly and pounding heart beat.  Over the next year and half I noticed myself experiencing extreme anxiety as well as social anxiety when around people. I lost weight and can?t gain any weight. My body is always cold. My hands and feet are always ice cold. I can?t sleep on my left side without waking up in the middle of the night with pains coming from my heart that?s beating against my rib bones. (Probably inflammation) Sept 2022: At work I was climbing down a ladder from a hot attic and experienced super sharp pains in my heart with each beat for a couple of minutes straight. My chest was very tight and anytime I would breath it felt very  sore. I felt the soreness for the next 2 weeks into October 2022.  Jan 1st 2023: I received my health coverage from PRIVATE Blue.  Now I?m able to have this issue addressed and that is what I?m trying to start here now. Please and thank you
Sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left injection site arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore left injection site arm). At the time of the report, VACCINATION SITE PAIN (Sore left injection site arm) 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.   Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-337382, MOD-2021-337387 (Patient Link).
Headache, ARM & NECK PAIN, LETHARGY, SORE THROAT Narrative:
This spontaneous report was received from a physician reffering to a patient of unknown age and gender. There was no information about the patient's concurrent conditions and medical history provided. On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX subcutaneously lot# R006753, expiration date 06-MAR-2020 or with dose of VARIVAX subcutaneously lot # N026999, expiration date 28-SEP-2019 (also reported as 20-SEP-2019), for prophylaxis. It was unspecified which lots of VARIVAX was given to the patient. The sterile diluent used to reconstitute the vaccine was properly stored. There was no adverse effect reported. Administered doses of vaccine were exposed to the temperature excursion of -14 degrees Celsius to -10 degrees Celsius (-13.7 degrees Celsius) for 2 hours 6 minutes. Data logger was involved. There were no previous excursions. This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-1808USA004533: US-009507513-1808USA004634:
20OCT92 pt recvd vax & 26OCT92 t101.4 & vomited; 28OCT92 red maculopapular rash, morbileform began spread to trunk neck, diaper area; no meds, no cough, no runny nose, no conjunctivitis; 2NOV92 pt seen; afebrile;
Injection site, left deltoid, became extremely hard, swollen, and warm. Site with petchiae like bruising greater than 1" circumference. Complained of extreme joint pain over body entire night with inability to sleep. Unrelieved with Advil. Symptoms resolving after 48 hours.
A nurse reported the occurrence of limb swelling in a 3 year old male who was vaccinated with Infanrix for prophylaxis. There was no relevant medical history, concurrent conditions, or concurrent medication. The subject had no adverse experiences following receipt of prior immunizations. On an unspecified date, the vaccinee received an injection of Infanrix (528E9); the number of previous injections of Infanrix was not reported. One day post-immunization, the subject's mother telephoned the vaccine provider and reported that the thigh into which Infanrix had been injected had swelled to twice the size of his other thigh. The physician prescribed Zyrtec. The event resolved after "several days."
After the 3 week period my husband suffered from a mild heart attack. It was very painful and he complained about not moving his arm for a day or 2 because how painful it was.
Fever got to 104.6,  freezing  so badly couldn?t feel hot water.  Our hands turned purple on the top and our fingers turned white, as if circulation issue - example of how it physically looked.  Couldn?t sit up without almost passing out.  Couldn?t walk without assistance.  Body aches so bad - I?ve never experienced this type of ache, and I?ve had three children.  This all started around 6pm same day of receiving the vaccine.  My husband started the same shortly after.  With exact symptoms, plus he had shortage of breath.  Fevers finally broke 1am- then we both felt better, until later the next day.   Body aches continued, not as badly as day before.  Sweating and chills.  Husband woke up the next night completely drenched from fever breaking.  Fatigue and soreness followed for next couple days.  By Tuesday April 6th finally felt normal again.   Minus continued sore arm.  Wanted to repost due to high fevers, feelings of passing out, and our hands turning purple.  Would think off coincidence if had it not happened to both of us.
Patient received incorrect vaccine as part of series. After Moderna COVID-19 vaccine was administered 03/03/2021, patient was given second shot 03/24/2021 of Pfizer.
she experienced side effects; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (she experienced side effects) in a 3-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. AU5509B) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In 2023, the patient experienced IMMUNISATION REACTION (she experienced side effects). At the time of the report, IMMUNISATION REACTION (she experienced side effects) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported.  Reporter asked what vial the patient received. Reporter stated that vial was not expired and believed that the syringe was only filled to 0.25mcg but was not 100 percent sure.  Patient only had Moderna vaccines, and this was the first time she experienced side effects.  No treatment drug was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-743797.   Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2023: Live follow-up received contains non-significant information. On 04-Oct-2023: Live follow-up received contains non-significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743797:Invalid Case (for other children)