chrisvoncsefalvay/vaers-outcomes huggingface dataset:
As a first time mother, I should have been thoroughly explained each and every vaccination my two month old son was going to receive. However, I was not, and only given a white sheet with bare minimal information to read over on my own with no assistance from the medical professionals. My son was administered numerous vaccinations without me signing any type of paper work or receiving explanations on what type of adverse reactions to look for afterwards. Immediately after the vaccinations being administered my son cried and screamed of distress for almost 2 hours straight. After finally settling him down he refused to eat and he went into a deep sleep. After a 6 hour nap, I forced my son to wake up and his entire face and eyes were swollen immensely and had hives. He still would not eat (had been almost 9 hours since his last feeding). I immediately took my son to the emergency room where we stayed and were closely observed for hours and administered TYLENOL as his fever came down. He slept until we left the hospital, and were discharged with swelling and hives still present. After getting home, he still refused to eat and I administered more TYLENOL and he stayed asleep. He was not sleeping as he normally does, but rather a very deep sleep. He woke up at approximately 8 AM, and was still not interested in eating a bottle. I forced him to eat 2 oz as it had almost been 20 hours since his last feeding. He immediately projectile vomited all over himself, me, our clothes, and bed. I bathed him, he passed a large bowel movement, and he began to feel a tiny bit better. I got him into a new pediatrician and his hives and swelling were still noticeable. This pediatrician believes that he had a severe allergic reaction to vaccinations. However, he still has swelling and trouble with appetite and sleepiness over 24 hours later.
Approx 2 weeks following vaccine, severe pain in lower back, groin, pelvis , legs resulting in admission to hospital due to inability to ambulate requiring wheelchair .
Immediately after HPV4 was administered today around 11:00 am, client fainted and convulsed for approximately 5 seconds. She immediately recovered consciousness and appeared confused for a short period. She indicated that she felt like being in a dark roller coaster tunnel with her little sister screaming. She complained of weakness, anxiety and for a few minutes she also expresses feeling strange as an impending doom feeling. BP and HT were taken WNL and patient was observed for approximately one hour until she fully recovered. Patient went home verbalizing that feels well and she appeared fine just like before injection, happy and playing with her little sister. It is very important to note that her brother received a second HPV4 dose an hour later and surprisingly a very similar reaction occurred. Adverse event also completed for her brother.
Localized erythema, warm to touch x 2 days 11cm x 8cm. Tx: pediatric care, warm compress.
Just had the typical muscle aches & pains & arm a bit sore. However, have also been experiencing some tightness in my chest . Not severe but I just did not have this before I got the booster shot. It may be from congestion that I have a tad of but wanted to report it in case it was a side effect to the vaccine shot.
Patient noticed a red, itchy area a couple inches below the site of injection that began about 4 or 5 days after the injection of Prevnar13. No pain or swelling, but itching has persisted for a few days. She will use hydrocortisone.
HIV+ patient. Trivalent influenza vaccine (Sanofi) administered 10/24/06.  72 hours vaccine, patient reported painful left-sided facial rash.  Patient examined 11/2/06 - symptoms consistent with herpes zoster. Rash resolving, no post-herpetic neuralgia.  No hearing or visual complications.
PUSTULES; RASHES; SWELLING; CHILLS; FEVER; PAIN; This spontaneous report received from a consumer concerned a 65 year old female. The patient's height, and weight were not reported. The patient's past medical history included breast biopsy, and other pre-existing medical conditions included breast biopsy done.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 09:15 am for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-MAR-2021, the subject experienced pain. On 08-MAR-2021, the subject experienced chills. On 08-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced rashes. On 09-MAR-2021, the subject experienced swelling. On 11-MAR-2021, treatment medications included: ibuprofen. On an unspecified date, the subject experienced pustules. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99 F. Additional treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, rashes, pain, chills, swelling, and pustules. This report was non-serious.
really bad sweats, sweats lasting quite a while; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (really bad sweats, sweats lasting quite a while), PYREXIA (fever) and CHILLS (chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNKNOWN) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (really bad sweats, sweats lasting quite a while), PYREXIA (fever) and CHILLS (chills). At the time of the report, HYPERHIDROSIS (really bad sweats, sweats lasting quite a while), PYREXIA (fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       no concomitant medications reported. no treatment details reported.
FELT LIKE A TRUCK HIT; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin) dose was not reported, administered on 01-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 03-JUL-2021, the subject experienced felt like a truck hit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt like a truck hit was not reported. This report was non-serious. This case, from the same reporter is linked to 20210738403.
-Hives almost immediately after receiving vaccine -Swollen, red, raised circle around injection site, about the size of my palm, started 1-2 days after injection, lasted 2-3 days -pain at injection site for at least 2 weeks afterwards -fatigue, chills, headache, malaise starting the day after the vaccine and lasting 2-3 days
big lump on arm; red round circle on arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 04-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (big lump on arm) and VACCINATION SITE ERYTHEMA (red round circle on arm) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE INDURATION (big lump on arm) and VACCINATION SITE ERYTHEMA (red round circle on arm). At the time of the report, VACCINATION SITE INDURATION (big lump on arm) and VACCINATION SITE ERYTHEMA (red round circle on arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details and concomitant medications were not reported.
greater than 35 days from first Covid-19 vaccine to second; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 35 days from first Covid-19 vaccine to second) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 35 days from first Covid-19 vaccine to second). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 35 days from first Covid-19 vaccine to second) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment medications were not provided by the reporter.
Based on information previously received, the suspect was coded to  influenza vaccine from Sanofi product NOS (not otherwise specified), case considered valid and the classification was corrected.  Initial information was received on 12-Nov-2020 regarding an unsolicited valid serious case from a consumer/non-health care profession (patient) via media.  This case involves a patient (unknown demographics) who had Guillain-Barre syndrome, when received INFLUENZA VACCINE.  Medical history, medical treatment(s), past vaccination(s) concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number, expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious Guillain-Barre syndrome (unknown latency) following the administration of INFLUENZA VACCINE. It was reported as the patient cannot take vaccine as the patient had Guillain barre and wears mask.  This event was assessed as medically significant.  Laboratory data was not provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting the outcome of event was unknown.  Information on batch number was requested for this case; Sender's Comments: This poorly documented case concerns a patient, who had Guillain-Barre syndrome after vaccination with INFLUENZA VACCINE produced by unknown manufacturer. The time to onset is unknown. Additional information regarding medical history, condition at the time of vaccination and lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
From 3/16/18 telephone triage encounter. Pt seen on 3/14/18, received DTap/IPV and MMRV. Mom states pt's right arm, just above the elbow and below injection site is red, swollen, and warm to the touch. Just noticed this morning. Was not there last night. Area of redness is the size of mother's palm. Pt states it is painful. Reaction is in the arm that received DTap/IPV. He was treated for localized reaction as well as cellulitis. 5 days of oral steroid and Augmentin. Also TYLENOL, ibuprofen and BENADRYL PRN.
Swelling (hard) upper 2/3 of upper arm - local hard, hot, fine bumps. Iced & ADVIL. Soreness - day of.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unknown date in 2007 the patient was vaccinated with ZOSTAVAX (lot# was not reported, dose route was not reported). On an unknown date the patient experienced varicella like rash. The patient visited to physician's office to seek medical attention. Unspecified treatment was given for the adverse event. The outcome of varicella like rash was reported as recovering/resolving. Additional information is not expected.
develop fever 103 approx 12hrs p/vax; t103 x 24hrs then dec to 100;red rash trunck;red circles under eyes;sclera inj bilat, irritable, inc sleeping
Approx 930PM on 16JUN91 pt devel "high fever" (104 @ highest) & began crying as if in pain; APAP given; crying lasted 930PM-4AM; Seen next day @ ER;
Bells Palsy; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bells Palsy) 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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BELL'S PALSY (Bells Palsy). At the time of the report, BELL'S PALSY (Bells Palsy) outcome was unknown.            Concomitant drugs were not reported. Treatment medications were not provided.  It was reported that patient experienced Bell's Palsy after 2 days of dose 2 and wanted to know if patient can take booster dose as one internist said not to take it because there was a possibility to develop Gillian barre syndrome.
Chills; Fever; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the right arm on 08May2021 at 10:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included undifferentiated connective tissue disease, osteoporosis, controlled nonfamilial obstructive sleep apnea syndrome and aortic valve replacement. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the right arm on 17Apr2021 at 10:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. The patient previously also received paracetamol; oxycodone hydrochloride (PERCOCET), simvastatin (MANUFACTURER UNKNOWN) and naproxen (NAPROXIN) and experienced drug allergy. On 09May2021 at 15:00, the patient experienced chills, fever and body aches. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events chills, fever and body aches was recovered on an unknown date in May2021.  No follow-up attempts are needed. No further information is expected.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Weakness-Medium
07/11/22 presents to ED for "fatigue and chest discomfort". PMHx of "ESRD (s/p kidney transplant 2015), CAD, DM II, HLD, HTN, obesity, and gout"
Patient erroneously received a 3rd dose of the series, which was discovered when administering RPh charted the dose. Initial dose given on 3/30/2021. Second dose (assumed 1st) given 1/17/2023.
Mother called approximately 2 hours after vaccines were administered. Mother states he has hives on his face and neck. He is resting comfortably. She called private MD who referred he to clinic. Mother advised to seek medical care at PP's office or urgent care. No respiratory problems only hives. 7/12/06 PHN spoke with father child doing well. Mother followed up with private MD no other medical care required.
Large red welt around where vaccine was administered in Right deltoid. Warm to the touch, itchy. Treatment- Benedryl every 4-6 hrs as needed for itchiness, swelling.
This spontaneous report was received from a pharmacist referring to a 60 year old non pregnant female patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 29-OCT-2016, the patient was vaccinated in her right arm with ZOSTAVAX subcutaneously, lot # L034726, expiration date on 09-DEC-2016 (strength and dose number were not provided). On 30-OCT-2016, the patient experienced nausea, vomiting along with diarrhea and some itching at the injection site, no rash noted. It was reported that no specific treatment had been given for the events. There was no intervention to prevent serious criteria, the case did not involve cancer or overdose. No product quality complaint was involved. The outcome of vomiting, injection site pruritus and nausea was reported as recovering, but the outcome of diarrhoea was reported as not recovered. The reporter did not assess the relatedness between the events and ZOSTAVAX. Additional information has been requested.
Approximately 1 day after my 2nd dose I experienced extreme migraine which was very unusual - I have never had migraine before. I also passed out twice and had severe diarrhea which lasted for 3 days. The migraine up to this day still occurs up to this day 01/31/2022. I consulted my doctor regarding my condition but she cannot determine if this was due to the vaccine or my ear problem. As of right now I am taking Nortriptyline (25mg) and Sumatriptan (100mg) for my migraine.
This spontaneous report was received from a nurse practitioner via a company representative and refers to a 17-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 28-JUN-2010, the patient was vaccinated with the first dose of GARDASIL, intramuscularly, (dose, lot#, expiration date were not reported). On 01-AUG-2010, the patient was vaccinated with the second dose of GARDASIL, intramuscularly, (dose, lot#, expiration date were not reported). On 22-OCT-2010, the patient was vaccinated with the third dose of GARDASIL, intramuscularly, (dose, lot#, expiration date were not reported), which was off schedule. No adverse effects was reported.
Had a terrible time breathing; Had to use her oxygen more often; A spontaneous report was received from a consumer, concerning herself, a 72-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed a terrible time breathing and had to use her oxygen more often.  The patient's medical history reported included chronic obstructive pulmonary disease (COPD).  Concomitant product use was not provided by the reporter.  On 02 FEB 2021, prior to the onset of the events, the patient received their first of two doses of mRNA-1273 (lot number: unknown) in the left arm for prophylaxis of COVID-19 infection.  On 02 FEB 2021, since patient took vaccine, she had started to have a terrible time in breathing and has had to use her oxygen more often.  Treatments of these events included oxygen.  Action taken with mRNA-1273 in response to the events were not reported.  The outcome of the events had a terrible time breathing and had to use her oxygen more often were considered unknown at the time of this report.; Reporter's Comments: This report concerns a 72-year old female patient with medical history COPD who experienced non-serious events of dyspnea and increased use of oxygen within 2 days of his receiving the  mRNA-1273 (Lot # 039K20-2A). Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidity
This is a spontaneous report from a contactable nurse (patient) reported that: A 52-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0178, Expiry Date was not provided), via an unspecified route of administration in left arm, on 16Aug2021 (age at vaccination was 52-Years-old) as DOSE 2, SINGLE for COVID-19 immunization at Hospital. Medical history was not reported. The concomitant medication was not reported. Patient had known allergies of Rocephin and Macrodantin. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8731, Expiry Date was not provided), via an unspecified route of administration in left arm, on 20Apr2021 (age at vaccination was 51 Years Old) as DOSE 1, SINGLE for COVID-19 immunization. The patient did not receive any other vaccines in four weeks. Patient did not receive any other medications in two weeks. Patient did not have COVID prior vaccination. Patient has not been tested post vaccination. On 16Aug2021, patient said that she got the shot in her left deltoid. she had headaches, joint pains and generalized bodily pain. Dizzy and tired the entire time. She then developed intermittent fevers for 4 days along with swollen armpits but more on my left armpit. Then 2 inches below the injection site, she developed a lump which was itchy, swollen and red. And for approximately a week, she couldn't blink her right eyelid normally without 'quivering' or like 'spasmic movements. She just couldn't close her right eyelid right. When she tried to close her eyes to sleep, her right eyelid would try to open by the spasmodic or quivering sensation. It all went away after about a week of misery. AE did not result in anything. Patient received treatment for all the events with Tylenol/Motrin intermittently. The outcome of all events was recovered on 2021.   Follow-Up (08Sep2021): Follow-up attempts are completed. No further information is expected
On 4/28/2021 pt had what seemed to be a normal Tdap immunization in left deltoid administered by MA. Pt was in clinic for back pain but consented to the Tdap because it had been more than 10 years since she had one. She returned to clinic for follow up back pain one week later and reported that she had pain and decreased range of motion in her left arm, but that her symptoms were improving. A week later she returned for follow up back pain and said that pain had worsened much 3 days after she had been here. She had gone to clinic for treatment. She has had follow up appointments with physical therapy and has been out of work because of this pain and decreased ROM. She has also been out of work during this time because of back pain.
Fungal infection rash on chest, back,, right armpit, and right arm Heart Palpitations  Increased resting heart rate
Itchiness, warmth, thickness in area, soreness, raised red area 2 inches by 3 inches, fading after 6 days. No treatment.
It was reported in a published article that a male child who on approximately 8/14/93, at the age of 14 months, was vaccinated with a dose of MMR (second generation). Subsequently, the patient's mother noted that the child was a lot different by 18 months and was subsequently diagnosed with Asperger's Syndrome. It was noted that the child was routinely vaccinated. In conclusion, the author stated that in spite of its limitation, this study suggests that an autism/vaccine connection may exist. Upon internal review, Asperger's syndrome was determined to be an other important medical event (OMIC). No further information is available.
Difficulty breathing after 20 minutes of having vaccine and soon after got a rash. By August 9, my feet began to get swollen & I felt pain.