chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event/ No known pt adverse events; Indavertently administered improperly stored GARDASIL 9/ Vaccines went out of range - temp. Vaccines given despite temp excursion.; This spontaneous report was received from a licensed practical nurse (LPN) regarding to a 15-year-old female patient. The patient's concurrent conditions, pertinent medical history, concomitant therapies, drug reactions, and allergies were not provided.  On 28-JAN-2022, the patient was vaccinated with an improperly stored doses HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot number U007667 with an expiration date of 23-MAY-2023 second dose, intramuscularly, in her right deltoid (dose, strength and formulation were not reported) and varicella virus vaccine live (Oka/Merck) (VARIVAX), lot number: U020239, expiry date: reported as 23-JUN-2023, but upon internal validation, established as 28-JUN-2023, second dose, subcutaneously, in her left arm (strength, dose and formulation, were not reported) for prophylaxis (product storage error). There were no known patient's adverse events (no adverse event). Administered dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) experienced the temperature excursion of 27.2 degrees Fahrenheit (F) and 49.8 F for 8 hours 30 minutes and 21 hours and 15 minutes respectively. There were no previous excursions reported. Temperature excursion details for varicella virus vaccine live (Oka/Merck) (VARIVAX) were not provided. Digital Data Logger was involved.  This is one of nine reports received from the same reporter. ; Sender's Comments:  US-009507513-2202USA007811: US-009507513-2202USA007814: US-009507513-2202USA007815: US-009507513-2202USA007816: US-009507513-2202USA007817: US-009507513-2202USA007818: US-009507513-2202USA002574: US-009507513-2202USA007813:
redness / at the injection site / redness / reappeared; soreness at the injection site / soreness reappeared; felt tired; not feeling well; This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received on unknown date).   On 20th October 2020, the patient received the 2nd dose of Shingrix. In October 2020, less than 2 weeks after receiving Shingrix, the patient experienced injection site erythema, injection site pain, tiredness and feeling unwell. On an unknown date, the outcome of the injection site erythema and injection site pain were not recovered/not resolved and the outcome of the tiredness and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain, tiredness and feeling unwell to be related to Shingrix.  Additional deatils were provided as follows: The patient was vaccinated with 2nd dose of Shingrix and experienced redness, soreness at the injection site and felt tired. The symptoms were  resolved in a few days but then the redness and soreness reappeared. They did not know the exact days that the symptoms were resolved and then reappeared. The reporter consent to follow up.
This case was reported by a physician and described the occurrence of fever in a 4 month old patient who received DTAP, Hep B recombinant, and IPV combined Pediarix for prophylaxis.  On an unspecified date when the patient was 2 months of age, the patient received the first injections of Pediarix, Hib (manufacturer unknown), and 7-valent pneumococcal conjugate vaccine (Prevnar).  At an unspecified time post-immunization, the patient developed a fever of 101 degrees F.  The fever resolved after an unspecified period of time.  On 06/16/2003 the patient received the 2nd doses of Pediarix, Hib (manufacturer unknown) and 7-valent pneumococcal conjugate vaccine (Prevnar).  On 06/17/2003, one day post-immunization, the patient experienced a fever of 104 degrees F.  The patient's mother telephoned the vaccine provider for guidance.  The outcome of the episode of fever is unknown.
face felt very warm devel rash on tope of feet, h/a; throat felt funny (constricted) chest face & neck look like sunburn & itch feels like has the flu; MD told pt it was probably something ate
Changes in her menstrual cycle are debilitating and have already lasted four months thus far, including *more severe cramping  *heavier bleeding  *much more intense pain  *more fatigue *inability to sleep--almost inconsolable at night on two separate cycles; never previously had sleep loss due to period pain *new symptoms of bloating, loss of appetite, and constipation that turns into diarrhea that never previously coincided with menses *absences from schoolon 12/7/21 and 1/7/22 both due to severe menstrual pain & cramping since vaccination.  Pt had never missed school due to period previously.  This side effect jeopardizes her 4.0 GPA and athletic pursuits *absences from trackincapacitation 3/7/22 workout after being awake past 3 am due to pain.  This stands in stark contrast to Sept 2021 when she surprisingly had to do a cross-country workout in jeans on the first day of her period (without having any previous cross-country training for the many weeks prior).
Headache beginning within 6 hours Fever at 30 hours lasting about 12 hours at 100 degrees to 102 degrees then  sought lingering headache by 48 hours  Treated with Tylenol, hydration and sleep
patient got second dose 21 days after first dose not 28 days/she got second dose earlier than what she was suppose to; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient got second dose 21 days after first dose not 28 days/she got second dose earlier than what she was suppose to) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E21A and 053E21A) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient got second dose 21 days after first dose not 28 days/she got second dose earlier than what she was suppose to). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient got second dose 21 days after first dose not 28 days/she got second dose earlier than what she was suppose to) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by reporter. No treatment details were provided by reporter.
Exactly one month later hitting 31 August I experience full body rash starting from my thighs to my legs to my toes going to my entire back up into my chest. Red dots everywhere of extreme itchiness and scratching. It will happen 3-4 times a day. Last about an hour or two and completely go away.  This outbreak has happened to me about 11 times all together and it?s still happening. I have tried everything to stop it I have not changed detergents I have not gone outside by plants I have not been around animals or be in different foods of any sort.
Patient taken to Hospital by ambulance complaining of nausea, vomiting and some mild chest discomfort.  Around 830pm he began to get nauseated and 9:30 pm had episode of vomiting.  States the episode lasted for 40 minutes.  Patient given 2 doses of Zofran, a dose of nitroglycerin.  Nausea resolved.  Chest pain improved.
VERTIGO, CHILLS, NAUSEA, HEADACHE,  LEFT ARM ARM UP TO BASE OF SKULL
2days after vaccine administration, left arm hot to touch, swollen, the size of an orange, sore throat, and achy all over. Instructed to place cool compresses periodically and contact PCP and to call after sees her PCP
in the past I have gotten a lump in my neck, like a swollen gland that eventually goes away; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 04Mar2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received flu vaccine on an unspecified date. Caller received first dose 04Mar2021 and second dose scheduled for 25Mar2021. Caller asked if she should get second injection on the same arm and stated: in the past she had gotten a lump in her neck, like a swollen gland that eventually went away. Her Doctor told her to definitely go get the Covid19 vaccination, the lump usually resolves. Caller mentioned they do not know if the lump was caused with another vaccine or with the flu vaccine in the past. The outcome of event was recovered on an unspecified date.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Occurring at the injection site: red circular rash, pain, itching, and swelling. A knot has formed as well. It is painful to the touch and itchy.
After getting the shot he stood on the side of counter waiting for his parents to finish getting their shot.  After couple minutes he looked pale and said he's dizzy & lightheaded.  Laid him on the floor and lifted legs unto a chair.  He also said he felt nauseated, hands cold and sweaty.  After laying on the floor the dizziness and lightheadedness subsided, returned after standing for a few minutes.  Had him stay in the pharmacy for over half an hour monitored for further syncope episode subsided.
Within 24-36 hrs had fatigue, achyness just tired after second dose; Within 24-36 hrs had fatigue, achyness just tired after second dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Within 24-36 hrs had fatigue, achyness just tired after second dose) and FATIGUE (Within 24-36 hrs had fatigue, achyness just tired after second dose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: FLU VACCINE in 2021. Past adverse reactions to the above products included No adverse event with FLU VACCINE. Concurrent medical conditions included Drug hypersensitivity (Macrodantin), Dust allergy, Allergy (MOLD) and Sinus infection (6 months or more , taking allergy shots) since 01-Jan-2019. Concomitant products included ZINC from 30-Jun-2020 to an unknown date for COVID-19, BIOTIN, CYANOCOBALAMIN (B-12), PEARL, ESTRADIOL, SIMVASTATIN, MONTELUKAST SODIUM (SINGULAIR), GABAPENTIN, VITAMIN C [ASCORBIC ACID] and VITAMIN D NOS for an unknown indication.    On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PAIN (Within 24-36 hrs had fatigue, achyness just tired after second dose) and FATIGUE (Within 24-36 hrs had fatigue, achyness just tired after second dose). At the time of the report, PAIN (Within 24-36 hrs had fatigue, achyness just tired after second dose) and FATIGUE (Within 24-36 hrs had fatigue, achyness just tired after second dose) outcome was unknown.            No treatment medication was reported.    This case was linked to MOD-2021-396514 (Patient Link).
None.  Patient was 17 and EUA is approved for 18 and above.  Patient experienced no ill affects.
p/vax pt devel an inj site rxn characterized by pain, warmth, redness & swelling;pt also exp fatigue & gen achiness;seen by MD;pt recovered;
fast heart beat; ears ringing; pain in neck; terrible migraine for 4 days; Sore arm; Pain in head; Chills; Fatigue; Muscle pain; nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (fast heart beat), TINNITUS (ears ringing), NECK PAIN (pain in neck), MIGRAINE (terrible migraine for 4 days) and PAIN IN EXTREMITY (Sore arm) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A, 013A21A and 013F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No patient medical history was provided by the reporter.  Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced HEART RATE INCREASED (fast heart beat), TINNITUS (ears ringing), NECK PAIN (pain in neck), MIGRAINE (terrible migraine for 4 days), PAIN IN EXTREMITY (Sore arm), HEADACHE (Pain in head), CHILLS (Chills), FATIGUE (Fatigue), MYALGIA (Muscle pain ) and NAUSEA (nausea). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. In December 2021, HEART RATE INCREASED (fast heart beat), PAIN IN EXTREMITY (Sore arm), HEADACHE (Pain in head), CHILLS (Chills), FATIGUE (Fatigue), MYALGIA (Muscle pain ) and NAUSEA (nausea) had resolved. At the time of the report, TINNITUS (ears ringing), NECK PAIN (pain in neck) and MIGRAINE (terrible migraine for 4 days) had not resolved.
Immediately after vaccines were administered patient passed out for a short duration of time (under 1 minute), then became diaphoretic with nausea and attempts at vomiting. Blood pressure was approximately 80/50, with episodes of intermittent confusion with garbled speech. Unable to walk with assistance, or sit upright in a chair. Cold pack applied to nape of neck, along with O2 as a comfort measure. Refused juice drink due to complaints of nausea. EMS called to transport patient to ER for evaluation and treatment. Patient not sure where he was, or what city he lived in.
Hospitalization 7/5/22. Dose #2 of Pfizer Covid vaccine 3/27/21, LOT ER8730 Dose #3 of Pfizer Covid vaccine 12/16/21, LOT FJ8757, IM LD
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received SHINGRIX. In January 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In January 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the patient experienced injection site discoloration, swelling arm, pain in arm and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site discoloration, swelling arm, pain in arm and injection site pain were recovered/resolved. The reporter considered the injection site erythema, injection site discoloration, swelling arm, pain in arm and injection site pain to be related to SHINGRIX. Additional details were reported as follows: This case was previously reported to the doctor. The age at vaccination was not reported. The patient received SHINGRIX on left arm. The patient's injection site was initially red after the vaccination. But, the following day (1 day after receiving SHINGRIX), it turned black and blue. The patient described that, her arm was swollen, hurt really bad and was painful. All the symptoms were resolved after one week. After the second week post vaccination, the patient developed pain at the injection site that lasted a couple of days. On an unknown date, the patient recovered from injection site pain. The patient denied permission to contact their physician and would not provide her address or date of birth. Also, she did not have the lot number or expiry date of the vaccine. The patient stated that, she reported the symptoms to her pharmacist and they told her that, they would report it. The patient could not provide the name of the pharmacist that reported the information.
3 hours after vaccine, he screamed in agony for hours, stopped sleeping, stopped crawling, stopped talking. He just turned 3 still doesn't talk. We had a EEG done following issues. They gave me no info whatsoever I was simply told he won't have seizures. When I asked for copies of the scan they told me $25 per copy. Recommended by Doctor. I had also brought up that I didn't want to further vaccinate and that I have a autoimmune disorder (psoriasis). I was hushed right there.
On day 8, experienced 4" diameter red swollen area around injection site.  Warm to the touch.
post vax w/in seconds pt turned blue periorally & in extreme lasting 1min then recovered w/no further problems
Bruise & rash on left arm, below injection site- started 2 days after injection, getting better after 2 days Dizziness - starting 4 days after injection Face tingling - starting 5 days after injection
A non-serious spontaneous report of gave FLUMIST to a child with asthma was received from a health professional concerning a 41-month-old male. Medical history included mild asthma. On 04-Nov-2009, the patient inadvertently received FLUMIST. The doctor's office was informed the patient had asthma after FLUMIST was given. There is no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
Janssen COVID-19 Vaccine EUA 2:00am - severe vomiting that lasted for 6 hours and a fever 5:00am - fever 101.2 and severe body aches 6:00 fever 102 that wouldn't break for 24 hours My body ached so badly, it felt like someone was cutting me open with razor blades, my fever went from 101-102 for 24 hours and would not break, vomiting for 6 hours - I couldn't keep any food or liquids down, my pelvis to toes were completely numb - I couldn't feel my legs at all for 24 hours, my vision was very blurry w/ extreme disorientation for 48 hours, extreme fatigue - I slept for 72 hours (awake maybe 5 of those hours), extreme chills, and body shakes for 48 hours. Big goosebumps all over my body and very red cheeks/forehead for 24 hours.  Some of these symptoms lasted about a week after the vaccine (fatigue, soreness and brain fog)
Fatigue, chills, very sore arm from elbow to top shoulder/neck, headache, bone and muscle aches, loss of appetite, hitching of chest area but no rash/sporadic dizziness/unable to sleep.
Information has been received on 14-MAY-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 01-FEB-2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route 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 20-FEB-2016, the patient was treated at a hospital for a blistering vesicular outbreak, which was diagnosed as herpes zoster. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the 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. Additional information has been requested.
Injection in right deltoid, pt states she has redness swelling and pain at site. Advised to ice for 24h then heat and use ibuprofen.
Approximately an eight inch red band and swelling on the left arm 72 hours after the vaccine was adminstered.  This is the fourth of the series with no previous reactions.
Received vaccines on 8/28/07 and mom states that 2 days later, patient developed rash (hives) that's more on body.  Patient also with runny nose.
hot flashes; This case was reported by a consumer via interactive digital media and described the occurrence of hot flashes in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced hot flashes. On an unknown date, the outcome of the hot flashes was unknown.   It was unknown if the reporter considered the hot flashes to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for herself/himself. The age at vaccination was not reported. The reporter asked was hot flashes a symptom of the 2nd Shingrix shot. The follow-up would not possible as no contact details were available.
-  Severe headache - behind my eyes, temples, down the back of the neck and into the shoulders  -  Severe  muscle and joint pain and aches all over my body.  -  Severe chills and shivering.  -  The feeling of being "hot"  but without an abnormal temperature - mine usually runs about 97.6 and that is what I measured.  -  Totally "stuffed up" with some breathing difficulty - like you had a really bad cold that included your lungs.  -  Bloating or "fullness" in the stomach but no nauseousness.  -  Dizziness to the point of not being able to get out of bed or walk without hanging on to something - extreme "unbalance" and some "spaciness."  -  An elevated pounding heart-rate - running over 110 bpm all night and sometimes spiking at 125 bpm - - today, at about 8pm - after slowly declining all day - this has pretty much returned to normal which for me is about 60 bpm +- when resting.  -  Insomnia followed by night sweats  -  By 4:30 the next day most symptoms were gone except for a lingering mild headache
Patient was hospitalized with COVID-19 symptoms on 8/26/2021 with respiratory failure. Patient was subsequently intubated and mechanically ventilated for a total of 17 days before being make compassionate care by family on 9/14/2021.
The day following administration of Pediarix, Prevnar and HIB, mother called and was upset about fever of 104, leg pain and refusal to walk.
Information has been received from a physician concerning a female patient that had not started her menstrual cycle who on an unspecified date was vaccinated with a dose of GARDASIL (Lot #, expired date and route not reported). Physician stated that on an unspecified date, the patient experienced abdominal and vaginal pain. It is unknown if the patient sought medical attention. At the time of the report, patient's outcome was unknown. This is one of several reports from the same source. No further information is available.
Felt like the vaccine was burning through my veins in both of my arms....woke up in the middle of the night with it and could not get comfortable due to pain and due to burning sensation.