chrisvoncsefalvay/vaers-outcomes huggingface dataset:
numbness on the right side of her face; numbness on the right side of her face; This is a spontaneous report from contactable consumer (patient) via medical information team. A female patient of unknown age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration as a single dose at left arm on 21Apr2021 for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was stated that the patient experienced numbness on the right side of her face and the back of her tongue (towards the throat) on 21Apr2021, maybe one hour after the 1st vaccine dose. Patients 2nd Pfizer vaccine dose is scheduled for 12May2021. The outcome of the events was unknown.   No follow-up attempts are needed :information about lot/batch number cannot be obtained.
On 12-29-05 patient stated that he was unable to move his left arm.  On Friday, a nurse at the senior center looked at his arm and said that it was warm to touch and reddened from his shoulder to his elbow.
Bad headache, nausea, abdominal pain, low fever (99.4 degrees F), major joint and muscle aches all over, extreme fatigue, dizziness. Symptoms were acute for 24 hours and then improved. Still experiencing mild symptoms 40 hours after shot.
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Tachycardia-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe
Pt c/o lightheadedness and minor itchiness in sternal area.  Pt ambulated to medical bay.  VSS.  Airway clear, free of swelling/redness.  APP notified and at bedside.  Pt c/o nausea briefly, N subsided.  APP approved pt for d/c to home w/ spouse.  Education provided to pt for when to seek medical attn.  No medications required per APP.
Patient fell asleep at 2:30pm and was difficult to wake up at 9am the following day. Awake after chiropractor visit. Patient appeared somnolent at noon when patient seen in office. Positive Romberg noted on exam and mild tremor when hands fully extended. Tremor noted at neurology appointment 9/16/17, but Romberg test not mentioned. Patient walked out of office with a pedialyte popsicle.
patient had slight arm swelling and pain and developed headache after injection. she showed no dizziness or fainting . patient stayed in pharmacy for 30 minutes and showed no other symptoms . I checked with her later in the day and she said she was fine.
Woke up the morning after the vaccine with light headedness, chills, body aches, headache, nausea.
11/30/15 pt. called to report persistent soreness of (L) deltoid area where he had rec'd hi-dose flu vaccine injection 7 1/2 wks. ago. Denies other sx - no redness or swelling. Pain occurs with use or (L) arm - not while at rest.
Felt like she had the flu; Stayed on bed all day sleeping; Fatigue; Headache; Chills; Muscle Pain; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt like she had the flu), SOMNOLENCE (Stayed on bed all day sleeping), FATIGUE (Fatigue), HEADACHE (Headache) and CHILLS (Chills) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (allergic to the flu shot, NSAIDS) and Allergy (allergic to some chicken).    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt like she had the flu), SOMNOLENCE (Stayed on bed all day sleeping), FATIGUE (Fatigue), HEADACHE (Headache), CHILLS (Chills) and MYALGIA (Muscle Pain). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 20-Feb-2021, INFLUENZA LIKE ILLNESS (Felt like she had the flu), SOMNOLENCE (Stayed on bed all day sleeping), FATIGUE (Fatigue), HEADACHE (Headache), CHILLS (Chills) and MYALGIA (Muscle Pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.
to limit her mobility; Pain which she described as mid to low spinal pain; Headache; Chils; Nausea; This case was reported by a consumer via call center representative and described the occurrence of headache in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis.   On 2nd May 2022, the patient received the 1st dose of Shingrix and the 4th dose of COVID-19 VACCINE. On 2nd May 2022, 3 hrs after receiving Shingrix, the patient experienced headache, chills and nausea. On 3rd May 2022, the patient experienced pain in spine. On 4th May 2022, the patient experienced mobility decreased. On 3rd May 2022, the outcome of the headache, chills and nausea were recovered/resolved. On an unknown date, the outcome of the pain in spine and mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the headache, chills, nausea, pain in spine and mobility decreased to be related to Shingrix.     Additional Information: GSK Receipt Date: 5-May-2022 Reporter's comments: This case was reported by the patient. The patient received Shingrix along with a 4th COVID booster shot. The patient noted that 3 hours post vaccination she developed headache, chills and nausea which did resolve by the following morning. One day after receiving vaccine, the patient developed a pain which she described as mid to low spinal pain at evening. She stated the pain was severe enough to limit her mobility the following day and has not yet resolved. The patient referred to the healthcare professional and provided medical advice disclaimer. It was unknown if the reporter considered the headache, chills, nausea, pain in spine and mobility decreased to be related to COVID-19 VACCINE . The reporter did not consent to follow-up. Note: The vaccination date and onset dates were discrepant in narrative. As per reported age and the data reported in structured field, we have considered vaccination and onset dates of May 2022. Clarification raised for same.
On 3/31/2021, I developed swelling and bloating in the abdominal area. In addition, I developed burning, itching, swelling, and pain in the vaginal area. I saw my regular gynecologist, who did a vaginal culture. After she got the results back, I was told I had a yeast infection and was prescribed Diflucan. I took Diflucan for several days and saw no improvement. Two weeks later, I went back to the gynecologist, who then referred me to another Dr. in another city. I first saw Dr. on 5/8/2021. Dr. did a workup and discovered that I had Candida norvegensis, which is resistant to Diflucan. Dr. prescribed a regimen of boric acid suppositories once every night for 3 months. I followed his instructions, the symptoms improved and eventually went away. Unfortunately, though, after I completed the regimen, the abdominal bloating (but not the vaginal discomfort) returned. I went back to Dr., who then advised me to continue using boric acid suppositories for 3 more months. I did this, and again, when the regimen was completed, the abdominal swelling returned. At Dr.'s suggestion, I then went back on the boric acid suppositories. I am currently still using them, but Dr. has advised me to only use them every other day. On the days I don't take them, I can feel some of the abdominal swelling return.
Information has been received from a consumer concerning her 4 month old daughter with no medical history and no drug allergies, who on 10-DEC-2007 was vaccinated with a second dose of PEDVAXHIB (OMPC).  There was no concomitant medication.  On 12-DEC-2007 the patient experienced a fever, runny nose, and hoarseness.  The patient did not seek medical attention.  No laboratory diagnostics were performed.  At the time of the report, the patient had not recovered.  No product quality complaint was involved.  Additional information has been requested.
5:50 pm: Inject 0.23 ml VARIVAX. Pt becomes unconscious, slips to floor. Shakes x 3 sec, pale. 911 called. Recovers after 15 seconds with cold, clammy skin. Uses cold pak to face. BP taken 5 times. Skin color returns to normal. Pt states no adverse effects. Leaves 50 minutes after reaction 6:40 pm.
Pt reports malaise, swelling of lips and nostrils, headache, and slight difficulty breathing (lungs were "tight" per pt).  Symptoms began around 24 hours after vaccination and mostly resolved by 3 days later.  Pt did not seek medical care for reaction.
Eight days post COVID19 Moderna Vaccine to left deltoid, 1/17/2021, have developed swollen lymph node to left underarm, tender to touch and no redness to left under arm area.  01/18/2021, have developed redness skin  to below injection site to left deltoid. Left deltoid area has become slightly sore again. Same day and 2-3 days following injection had soreness to left deltoid area but no redness or swelling.
Patient developed hives over trunk face and extremities in evening after receiving vaccines. Atarax 5 mg every 8 hours X 4-5 days
Redness, induration 6 x 7 cm (R) upper/anterior/lateral thigh. Mother states she noticed reaction in morning day after shot given and it worsened over that day. She states today the redness seems less than yesterday.
Around 7pm, fatigue started setting in, but by 7:30pm chills and a fever began and patient retired to bed. Around 9pm, patient requested additional blankets and a glass of water. Around 11:20pm, patient was awoken by severe chills, dehydration, a heart rate of 127 bpm and a fever of 103 degrees Fahrenheit. ORS were administered in 1 liter of water and consumed within 30 minutes. At this point, patient was unsteady on her feet. OTC 500mg acetaminophen and 200mg ibuprofen were taken. Then, a medical professional was consulted and advised an additional 500mg acetaminophen be consumed. Patient returned to bed. Patient awoke feeling overheated around 3am. Patient attempted to cool herself with damp cloth for 15 minutes before turning on a cold shower. Patient then returned to bed with wet hair. Awoke around 6am and took another 1000mg acetaminophen due to headache, but thermometer was now reading 98.2. Fever broke during the course of night. Slight fatigue and body aches remained the next day. No further adverse affects.
A circular rash about 3 inches in diameter directly at the injection site. It is slightly itchy and feverish. I first noticed the rash on May 1st but I may have had it the day before.
Anxiety; dry mouth; headache; light-headed; nausea; elevated blood pressure. Doctor visit, Atavan prescribed.
This spontaneous report was received from a registered nurse referring to multiple unspecified patients (age and gender unknown). No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. The reporter stated that, on unspecified dates, the patients were vaccinated with improperly stored doses (incorrect product storage) of injectable ZOSTAVAX (lot# M032360, expiration date 18-AUG-2017; and lot# M034764, expiration date 26-OCT-2017) for prophylaxis (strength, dose, frequency, route of administration and anatomical location were not reported). The vaccine doses were exposed to a temperature excursion of 19.4 Fahrenheit degrees in a time frame of 3 hours and 45 minutes; digital data logger was involved and previous temperature excursion was confirmed. No adverse effects were reported. Reportedly, the vaccine doses were reconstituted with properly stored sterile diluent (DILUENT MRK) (lot number and expiration date were unknown). This is one of several cases received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA002390: US-009507513-1704USA001051:
Reddening of flu shot site. Tingling and numbness of palms and fingertips. Advised patient to use Benadryl and to consult a doctor.
PATIENT RECEIVED FIRST DOSE AT PHARMACY. ABOUT 2 MINUTES AFTER VACCINE, PATIENT EXPERIENCE SEIZURE LIKE SYMPTOMS (SEIZING) FOR ABOUT 30 SECONDS. HE DOES NOT HAVE A HISTORY OF SEIZURES. WE TOLD HIM TO STAY HYDRATED AND REPORT ANY OTHER SIDE EFFECTS. HE HAS NOT EXPEREIENCE ANY SIDE EFFECTS SINCE THEN.
allergic to Covid-19 shots; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:   A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergic to Covid-19 shots". Additional information: A consumer was calling because she has been dating an older gentleman who is allergic to COVID-19 shots.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Heart flutter over 200 times in 1 monitored week via stick on ekg recorder. Flutter lasts 10 to 20 seconds each.
Rotavirus vaccine given past maximum age range as first dose in series. Provider called mother and discussed error as well as that we believe she will tolerate this fine but that there is no good data on it being given for the first dose in babies over 15 weeks of age. Discussed potential concern for intussusception.
gave the second on the 15th day; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (gave the second on the 15th day) 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 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 (gave the second on the 15th day). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (gave the second on the 15th day) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
3 days after immunizations patient developed left arm weakness, which was progressive over next 8 days
13 year old patient received a dose of MENACTRA at the age of 11, inadvertently received an additional dose of Friday with no reported adverse event; Initial information received on 14-Feb-2022 regarding an unsolicited valid non-serious case received from the nurse.  This case involves a 13 years old female patient who received a dose of meningococcal a-c-y-w135 (d conj) vaccine [Menactra] at the age of 11, inadvertently received an additional dose of Friday with no reported adverse event.  The patient's past medical history, medical treatment(s), and family history were not provided. Concomitant medications included influenza vaccine (Flu Vaccine) for Prophylactic vaccination.  On an unknown date, the patient received meningococcal a-c-y-w135 (d conj) vaccine (strength, formulation, dosage, lot number: not provided) via unknown route of administration at unknown of site for immunization. Information on batch number was requested.  On 11-Feb-2022, the patient inadvertently received an additional dose of meningococcal a-c-y-w135 (d conj) vaccine (dose: 0.5 milliliter once) of Friday (lot number: U7207AB and expiration date 08-Feb-2023) via intramuscular route in left arm for immunization (extra dose administered) (latency: unknown). The reporter asked whether patient would require a booster at age 16 or prior to college.  No adverse event reported.  Action taken with meningococcal a-c-y-w135 (d conj) vaccine was not applicable.  At time of reporting, the outcome was Unknown for the 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 the guidelines. 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.
Right upper arm 19cm circumference. Left upper arm 22.75cm circumference. 20cm X 16.5cm area of redness with underlying tauntness to the underlying tissue missing about 2 cm coverage to circumferentially affect upper left arm.
I received my second covid vaccine on April 19th 2021. On May 4th 2021, I noticed a small skin irritation on both forearms. The next day the irritation had turn to a rash. The rash then spread to my face and covered my forearms by May 6th.  By May 7th the burning, itching, blistering rash had covered half of my face, both forearms up to the elbow, and my right leg. clinic on May 9th and the physician prescribed 60mg of prednisone for 4 days and decreasing in intensity for 10days. She was unclear what could have caused the rash and told me to report the reaction.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm, on 07Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 06Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12May2022, outcome "recovered" (01Jun2022) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12May2022) Positive, notes: testing positive; (18May2022) Negative, notes: Tested negative on day 7; (23May2022) Positive, notes: tested positive again on day 12. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Paxlovid from 13May2022 to 18May2022 for the treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
Dizziness, HYPERtension, CHILLS; BODY ACHES; FATIGUE; SORENESS AT INJECTION SITE; VERTIGO Narrative:  Other Relevant History:
Arm was numb and tingly. Injections given in AM 10-11. Called pt. at approximately 5pm said it was better but was achy at inj site (shoulder) tried to call on 10-12 no answer.
Hives on both arms, abdomen, back, legs, chest, neck. Not responsive to Benadryl .
On day 5 after I received the vaccine, I noticed a tender axillary lymph node on the same arm. It persisted but improved over the next few days. was present but nontender by day 8.
1750 Patient complained that throat was scratchy and felt like it was closing.  pulse ox 96% on R/A.  Benadryl 50mg given IM at 1752.  1802 Pt states she feels much better pulse ox 98-99% on room air, pulse 74.  Patient also complained of headache. VS @ 6:20pm, BP 132/80, HR 74bpm, 97% O2.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     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. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Covid arm Hard, warm, red lump at injection site which appeared a week later. Lump is warm and slightly painful to the touch. The area is sore and slightly itchy
I felt sluggish very fatigued and weak along with headache, cough, and sore throat for about 2 weeks.
tingling lips, swelling hands, sl flushed, dizzy, lightheaded, migraine area, memory loss, chest tight, wheezing, felt hot;DPH;EPI;
This spontaneous report has been received from a pharmacist and refers to a 91-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with ZOSTAVAX, 19400 plaque forming units (PFU), subcutaneously (dose, lot # and expiration date were not reported) for prevention of herpes zoster. On an unknown date, after receiving the vaccine, the patient developed shingles on their back. The outcome of the event and the relatedness between the event and ZOSTAVAX were not reported.
Chest pain, heart palpitations, elevated blood pressure, foggy head, neck and upper back pain Gradual reduction of chest pain, palpitations, and elevated BP. Neck and upper back pain, and brain fog persists currently.
About 2 hours after receiving Tdap and Hep A vaccines (4:30 pm) my daughter started to feel nauseous. Two hours later she started having bad abdominal pain and vomiting. She vomited about 6 times and her abdominal pain had gotten worse before I took her to the ER at about 9:15 pm.  She was given 1 dose of iv ondansetron, iv morphine, 30 cc of po Maalox and 1 liter of Normal Saline. An abominal ultrasound ruled out acute appendicitis and ovarian torsion while some debris was seen in the bladder. She had a urinalysis done that was negative. She never had a fever and that was documented at the ER and doctor's office earlier in the day. She experienced relief about 20 minutes after the iv morphine dose.  After ruling out other causes the ER assumed this was the beginning of a virus and sent us home with an RX for 4 doses of ondansetron (4mg po q6hr prn nausea) and warned us that she would probably could also have explosive diarrhea.  The next day she was able to eat the diet recommended by the hospital and she did not have any virus symptoms. She did have some abdominal pain later in the week only after drinking milk. That seems to have subsided. She has recovered from the event.  Considering the temporal relationship of the event and vaccine administration, and other causes ruled out, it's difficult to rule out an association between the vaccine administration and this event.
4/9 ED visit--hypokalemia, hypomagnesemia, hypertension 416--2nd Moderna injection 4/16 clinic visit for acute abdominal pain 5/6 cardiology 5/13 another clinic visit 6/15 ED visit