chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Crying unconsolably x 6-7 hours with refusal to nurse. Had large, watery stool with blood in it. Then settled and nursed well now stooling normally.
Received Tdap and HPV vaccine on 10/16/2006 noticed some blisters at the corner of mouth and swelling of lower lip on the evening of 10/18/2006 and facial swelling around eyes on 10/19/06. No fever, headache, dizziness or any GI symptoms. Information has been received from  nurse manager in a physician's office concerning a 15 year old female who on 16-OCT-2006 at 1600 was vaccinated in the right deltoid with the first dose of GARDASIL (lot # 653937/0637P). Concomitant therapy that day included DTP. Subsequently, the patient experienced an allergic reaction, her face and body began to swell. The physician recommended the patient take an unspecified dose of BENADRYL. After raking BENADRYL the patient's face and body swelling "went down". On 20-OCT-2006 it was reported that "the swelling became worse again". At the time of this report the patient had not recovered from the event. Follow up information was received from the patient's physician which stated that on 18-OCT-2006 the patient developed blisters in the corners of her mouth and swelling of her lip and face and she was seen in the office. She was treated with acyclovir for possible herpes simplex. Laboratory results from 19-OCT-2006 included HSV type 1 and/or 2 was 11% and Herpes simplex virus culture was negative. On approximately 23-OCT-2006 the patient was considered to have recovered from these events. On 02-NOV-2006 the patient reported swelling on her face and lower lip again. Laboratory results that same day included serum herpes simplex type 1 IgG Ab 5.6 and a eosinophil count of 11%. The physician reported that the patient recovered from these events on an unspecified date. This report was identified from a line listing obtained on request by the Company. A 15 year old female with no pre-existing conditions was vaccinated in 16-OCT-2006, intramuscularly into the right arm with GARDASIL (lot#653937/0637F). Concomitant therapy that day included DTAP (Lot # C2572AA), vaccinated into the left arm (route unknown). The patient noticed on the evening of 18-OCT-2006, some blisters at the corner of her mouth and swelling of lower lip and facial swelling around her eyes ib 19-OCT-2006. There was no reported fever, headche, dizziness or any gastrointestinal symptoms.  Additional information has been requested.
Patient had come in on 10/25/15 to report redness, warmth and inflammation on the upper arm in which vaccine was given. Redness, rash was persisting. Patient had reported event to her doctor.
In the evening of the same day that I received the Moderna vaccine, my right leg started swelling and I did not feel well, I went to sleep, and in the morning my leg was extremely swollen starting at the thigh, continuing to the lower leg and including my foot. The muscles or ligaments in my swollen foot were so tight it gave me great pain to walk!  This lasted for more than ten days and slowly after that got better, with me being able to walk little by little without a lot of pain in my foot.  My leg continues to be swollen, and I am still recovering from the adverse reaction to the vaccine.
Post vax, about 13:00, pt began low-grade fever and slept for a few hours. At 18:00, the same day, temperature was 101.8F and baby was shaky and trembling. Eye became fixed, color was blue and vomited. EMT's were called and took baby to ER. He had a chest X-ray to check for aspiration. Pediatrician was notified. He received 2 breathing treatments and started on Augmentin. He vomited 2 times, total. On 1/2/01, parents report baby is acting ok, today.
I was changing child's diaper, noticed left foot/ ankle edematous, erythema, and warmth. What appeared to be bruising (later ID'd as purpura) notable to posterior left ankle. Pedal pulse diminished, toes cyanotic. Left to ER. At assessment in ER noted irregularities to right foot as well with RN. Transient hives noted to bilateral lower and upper extremities. ER doctor administered X-rays which were negative. A diagnosis of vasculitis, likely HSP was given. After 3 days of steroids, swelling to ankles, feet and knees have subsided. 1/21/17 minimal urine output, small yellow BM with minimal mucous purpura seems worse and is present on thighs and medial legs bilaterally, as well as posterior forearms. 1/22 urine output better,no BM. 1/23 Edema is subsiding, purpura appears to be diminishing, output increasing.
Left arm swelling, armpit and collar bone lymph nodes swollen, rash spreading down arm starting at injection site.
three days of fevers; three days of / myalgias.; This case was reported by a physician and described the occurrence of fever in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced fever and myalgia. On an unknown date, the outcome of the fever and myalgia were recovered/resolved.   It was unknown if the reporter considered the fever and myalgia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. In October 2019, the patient received 1st dose of Shingrix. After this, she had three days of fevers and myalgias.  The events were resolved. For tolerance to 2nd dose refer linked case US2020AMR197673, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR197673:same patient (2nd dose)
felt I couldnt move; Fever; chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-May-2021 and was forwarded to Moderna on 18-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (felt I couldnt move), PYREXIA (Fever) and CHILLS (chills) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Migraine. Previously administered products included for an unreported indication: IMITREX DF.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced MOBILITY DECREASED (felt I couldnt move), PYREXIA (Fever) and CHILLS (chills). At the time of the report, MOBILITY DECREASED (felt I couldnt move), PYREXIA (Fever) and CHILLS (chills) had resolved.            Action taken with mRNA-1273 in response to the drug was not applicable. No concomitant medication information was provided. No treatment medication information was provided    This case was linked to MOD-2021-143665 (Patient Link).
TACHYCARDIA; MEDICATION ERROR; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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 not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-AUG-2021 for prophylactic vaccination. Concomitant medications included bnt 162 for prophylactic vaccination. On 06-AUG-2021, the patient experienced tachycardia. On 06-AUG-2021, the patient experienced medication error. On 06-AUG-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tachycardia, and fever, and the outcome of medication error was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per the standard procedure as the case is assessed as non-serious.
Patient was administered the Bexero vaccine in Left Deltoid on 10/16/23 @ 3:00pm. Patient messages the clinic on 10/21/23 stating that extreme shoulder pain and reduced range of motion occurred a few hours after vaccine administration. Pt was offered an in person appointment on 10/24/23 or to go to Urgent Care/Emergency Department for immediate medical care. Patient messages again on 10/25/23 stating that they still have limited mobility after a week and 2 days from the vaccine. Patient will be seen tomorrow 10/26/23 in clinic with one of our providers.
Burning Sensation in the Right Eye; Itchy around Right Eye; Swollen Face; Red Face; Drooping Right Eye; Headache; This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (Burning Sensation in the Right Eye), EYE PRURITUS (Itchy around Right Eye), SWELLING FACE (Swollen Face), ERYTHEMA (Red Face) and EYELID PTOSIS (Drooping Right Eye) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced EYE IRRITATION (Burning Sensation in the Right Eye), EYE PRURITUS (Itchy around Right Eye), SWELLING FACE (Swollen Face), ERYTHEMA (Red Face), EYELID PTOSIS (Drooping Right Eye) and HEADACHE (Headache). At the time of the report, EYE IRRITATION (Burning Sensation in the Right Eye), EYE PRURITUS (Itchy around Right Eye), SWELLING FACE (Swollen Face), ERYTHEMA (Red Face), EYELID PTOSIS (Drooping Right Eye) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. Pertinent medical history, concurrent conditions and concomitant therapies were not reported. The reporter stated that the patient received the third dose of GARDASIL 9 earlier than the recommended dosing schedule; as the patient received the first dose on 08-APR-2016, the second dose on 24-JUN-2016 and the third dose on 31-AUG-2016 (lot # M009378 and expiration date 23-APR-2018). (The doses, route, anatomical location and lot# of the first two doses were not reported). No adverse effects were reported and a product quality complaint was not involved. Additional information has been requested.
Days after receiving my first vaccination, I began having strange sense of taste and smell. The issue has not resolved and seems to be getting worse. I had my second vaccination yesterday, so I am unsure how that will affect it. Cooked meats, toothpastes, soaps, charred vegetables, etc. all produce a strong gasoline-like odor that makes eating/brushing teeth extremely difficult. I?ve altered my diet to include very basic foods without much flavor. Not all foods have the smell, but when the smell is present it is pungent and I cannot stand to eat it. I am not experiencing a loss of smell, but definitely have lost 30-40% of my ability to discern smell beyond the chemical/gasoline sensation I mentioned earlier.
Patient reported via phone that she had developed welts on her upper arm from elbow to shoulder x3 days
Sat AM (10-19-19) woke up with itchy (L) collar bone - progressed to neck, back, and chest with no abdomen. (+) shoulders, no face (+) chin. hives->hot, itchy bumps with fluid - skin swollen.- still has itchy chest; (L) collar bone today - hives mostly gone. Took Benadryl Sat and Sun and Sun, didn't relieve sx. No PCP seen.
1 week after the vaccination the area around the injection site became itchy and a little bit swollen.  I developed a rash around 10 cm in diameter.
I had 2 doses of the Moderna vaccine. Shortly after the 2nd vaccination, a high-pitched ringing in my ears began. The ringing is continuous from the time I awaken until I go to sleep at night.  I thought it would go away.  It is distracting when I'm quiet meditating or reading.  I find myself making an effort to listen more closely to the tv and in conversations. I've given it time to subside on its own, but it has not. I asked Dr. for a referral for an audiological evaluation to find out if this affects my hearing acuity. I am waiting to be scheduled for an appointment.  I also noticed an unusual, wide horizontal band of redness like a rash an inch above my left elbow occur after the 2nd vaccine shot in April. It does not go away when I use over-the-counter skin medicine or eczema medicine. It doesn't look like eczema I've had in the past and is not located in an area I've ever had eczema. The rash is still there. It can itch but that is occasional.
feel dizzy; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (feel dizzy) and NAUSEA (nauseous) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced DIZZINESS (feel dizzy) and NAUSEA (nauseous). At the time of the report, DIZZINESS (feel dizzy) and NAUSEA (nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment information was not provided.
Rashes on body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rashes on body) 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 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced RASH (Rashes on body). At the time of the report, RASH (Rashes on body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment medication were not reported.
Patient received the vaccine on 1/31/2021. Patient complained of bleeding 2/7/2021.  Went to clinic where labs were conducted.  Patient had an INR of 12. Previous INR results were normal prior to vaccination.  Patient was also diagnosed with UTI and given antibiotics.  Patient was encouraged to go to ER. Patient died on 2/12/2021.
Shingles like rash on chest and under arm on right side.  Fever up to 101.
Information has been received from a physician concerning a physician concerning a 13 year old male who "seven years ago", in approximately 1999 was vaccinated SC with a 0.5 ml dose of varicella virus vaccine live. There was no concomitant medication. Subsequently, "last week" in July 2006, the patient developed breakthrough varicella with more than 50 lesions. Unspecified medical attention was sought. There was no product quality complaint involved.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EN6198), in right arm, on 15Mar2021 as dose 2, single (Lot number: EP7534), in right arm and on 10Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 64 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Jun2022 at 03:30, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: This is related to Paxlovid, not the vaccine. Exposed to Covid 14Jun. Symptoms presented 3:30 AM 17Jun. Began Paxlovid 17Jun late afternoon. Symptoms resolved except for being extremely tired 20Jun. Gradually felt better until 26Jun when I developed cold-like symptoms. Nasal congestion, coughing, sneezing but no fever. From everything I've read, this appears to be a rebound situation. I just wanted to report this so that you have data related to Paxlovid treatment.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 20-JAN-2017 at 09:04, the patient was vaccinated with an improperly stored VARIVAX (lot # M031969) for prophylaxis (expiration date, dose and route of administration were not reported). It was reported that the vaccine underwent previous temperature excursions, but the number of previous excursions, time frames and values of incorrect temperature were unknown. A digital data logger was used. No adverse effects were reported. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704USA000455: US-009507513-1704USA000456: US-009507513-1704USA000457.
approx 1 1/2wk p/vax pt c/o dizziness, lightheadedness, pressure to rt side of head (hot/cold sensations), mid back pain, increasing p/eating, wetness across chest;sx have cont to present date;coughing, CXR showed enlarged heart;
GBS, extreme pain, paralysis, bladder dysfunction, heat & cold sensitivity, fatigue;pt exp 5mo physical therapy going from a wheel chair, walker, cane & finally walking on own again;pt still bothered w/fatigue;pt unable to work x 1yr;
This case was reported by a consumer and described the occurrence of pain in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. After receiving the SHINGRIX the patient experienced sore and it was okay to apply aloe or ICYHOT to the area.
Patient states she got a high fever on 9/15/17. The upper part of her arm down to right below the elbow is red and swollen. Advised patient to take BENADRYL and see her physician if symptoms do not decrease in a few hours. She stated she would if needed.
Approximately one hour after receiving the vaccine, as the patient was driving home he began experiencing throat tightness and tongue swelling. Once home, they call 911 and administered 0.3 epi (had previous severe allergy to lidocaine). EMS then administered iv benadryl and an albuterol treatment. The patient was reported to go unresponsive en route and received bag and mask ventilation very briefly as well as additional 125g solumedrol and another IM epi injection. On arrival he was reported to be stable, talking, tolerating secretions, without significant complaints. He was observed in the ER for several hours without any symptoms nor objective findings to support anaphylaxis (tongue and airway normal, no wheeze, no rash). He was anxious in the ER and the treating physician wrote that he felt it may likely have been anxiety and not anaphylaxis based on their evaluation.
delayed rash near injection site that first developed about a week after I got the 1st dose. It has been 5 days so far and it is still there. It sometimes itches or hurts but usually doesn't bother me too much. Well update after I get the 2nd dose later this month.
Fever, chills, chest pain, upper abdominal pain, aches, dizziness, weakness,  joint pain, fatigue
RT UE 3cm round area of redness and induration. Additional spread to almost circumferential just proximal to elbow Rt.
Weakness; Low grade fever; Itch throat; trying to find out so that he doesn't know infect anybody else the COVID; got symptoms of COVID; This is a spontaneous report received from a contactable consumer (patient's wife) reported that a male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number and Expiry Date: Unknown), via an unspecified route of administration on 26Aug2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was calling on behalf of her husband who got the first dose of the Pfizer COVID-19 Vaccine last 26Aug2021 and after getting it, the husband got symptoms of COVID which was weakness, low grade fever and itch throat actually he was asking if, was it possible that these are the side effects of vaccine. The patient's wife did not know, he was not in here with me, she was trying to find out so that he doesn't know infect anybody else the COVID (Further clarification unknown). Reporter seriousness for all events were unspecified. The outcome of the events was unknown.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
8 days later I got a delayed localized allergic reaction at the injection site. I had a round rash about 3 inches wide and in diameter, red, slightly swollen, and itchy.   My doctor gave me prednisone, and my rash is slowly fading away within the 3 days