chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Unable to walk; Rash with Blisters all over the body; Rash with Blisters all over the body; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (Unable to walk), BLISTER (Rash with Blisters all over the body) and RASH (Rash with Blisters all over the body) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jun-2021, the patient experienced BLISTER (Rash with Blisters all over the body) and RASH (Rash with Blisters all over the body). On 18-Jun-2021, the patient experienced GAIT INABILITY (Unable to walk). The patient was treated with DEXAMETHASONE (DECADRON [DEXAMETHASONE]) at an unspecified dose and frequency. At the time of the report, GAIT INABILITY (Unable to walk), BLISTER (Rash with Blisters all over the body) and RASH (Rash with Blisters all over the body) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events were not Applicable. No concomitant medications were reported. The patient was injected with a steroid and waited for results to see if she needed to go to the emergency room.   This case was linked to MOD-2021-229617 (Patient Link).
This is a 50 year old female who presented on 1/10/22 with acute progressive shortness of breath and nonproductive cough in the setting of IDDMII, HTN, CKDIII with proteinuria, normocytic anemia, mild asthma (no PFTs).  Previously had two doses of Pfizer COVID-19 vaccine early in 2021. Tested positive for COVID on 1/10/22.  -Admitted to the ICU on contact/airborne precautions, transferred to the medical ward 1/16. -Required High Flow Nasal Canula up to 25L and 70%, titrated to 1/14 NC 7L, down to 0.5L 1/19. -Received Dexamethasone 6mg daily x 9 days today -Held Remdesivir in setting of AKI on CKD -Encouraged IS, provided on discharge -Received PRN APAP, albuterol, benzonatate and Dex-Guaifenisen -On ambulatory testing 1/19, required 0.5 L at rest and 1L with ambulation -Home O2 and pulse oximeter provided
High fever got up to 102.5 even after Tylenol.  Chills, shaking. stuffy nose.  Lasted exactly 24 hours and was then gone.
Patient just stated today, 5/17/18, of reaction of IMZ on day of 1st SHINGRIX vaccination given 3/17/18. We were calling for shot #2 reminder. Reaction described as redness and swelling near site, then progressed to swelling and rash on vaccinated arm below elbow. This and fever subsided after 3 days.
Clear vesicle formed at site of injection and subsequently ruptured, leaving a 2cm denuded area akin to a burn.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The nurse reported that the unspecified patient was administered the first dose of GARDASIL on an unspecified date "about a year ago", in approximately June 2012, (dose, route and lot # unknown) and the patient was "currently" in the physician's office, on 13-JUN-2013, and about to receive the second dose of GARDASIL (dose, route and lot # unknown). No adverse effect reported, Additional information has been requested.
Patient  received Pfizer BioNTech Vaccine at approximately 1647 and drove to observational area. Observer spoke with patient and review safety measures. Observer stated that at approximately 1652 patient stated that she feels as if she cannot swallow and her throat is tighten up. Emergency measures implemented-  Epi administered, oxygen applied,  EMSA called, vital signs taken. Patient maintained consciousness but continued to c/o throat tightness especially on the right side  and difficulty swallowing. No visible edema  noted at time of assessment. Patient transported to ER via EMSA.
Pt received vaccine at 12:47pm 11/22/10. Came back to the pharmacy around 5pm. Injection site has swollen, red, hot and itchy. Told her to ice it and take BENADRYL 50mg q 6 H, CMC in AM.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medication was reported.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-077929 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-077929:second dose case
April 14th Sore throat, dry cough, body aches, headache, foggy head, sinus pressure  April 15th All of the above plus a little dizzy
1) Local allergic reaction (IPOL & VARIVAX) on R deltoid also (arm) --> 9cm x 11cm.  2) neck torticollis
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Since April 2014 the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB (dose, lot# and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
pt felt unwell shortly after vaccine with profound weakness after 2nd dose. later developed SOB and was diagnosed with pneumonia (in March approximately 1 month after the second dose) subsequently had ongoing respiratory symptoms and was later diagnosed with pulmonary embolism/DVT in May
20 y/o gentleman developed acute kidney injury and nephrotic syndrome due to biopsy proven minimal change disease following vaccination.
next day--9:00 am - chills, muscle aches 10:00 am - fever 100.5C while on Acetaminophen  fever, chills, severe muscle aches, tiredness continuing all day two days following second dose--extremely swollen lymph nodes under left arm and on left side of throat (same side of body as injection site)-painful to raise arm and painful to swallow swollen lymph nodes persisted until four days following second dose
Burns like a sunburn; Aches; Redness at the injection site; Pain at the injection site that is increasing; Swelling at the injection site; Fever; Headaches; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of SKIN BURNING SENSATION (Burns like a sunburn), PAIN (Aches), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE PAIN (Pain at the injection site that is increasing) and VACCINATION SITE SWELLING (Swelling at the injection site) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SKIN BURNING SENSATION (Burns like a sunburn), PAIN (Aches), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE PAIN (Pain at the injection site that is increasing), VACCINATION SITE SWELLING (Swelling at the injection site), PYREXIA (Fever) and HEADACHE (Headaches). At the time of the report, SKIN BURNING SENSATION (Burns like a sunburn), PAIN (Aches), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE PAIN (Pain at the injection site that is increasing), VACCINATION SITE SWELLING (Swelling at the injection site), PYREXIA (Fever) and HEADACHE (Headaches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator o No treatment medications provided by the reporter
Severe redness & swelling 4.5" below the injection site. Later in the evening developed muscle pain, severe headache, shivering, fever & night sweats. Headache resolved by 10:00 am this morning. Muscle pain as well as swelling  & pain below below the injection site persists.
nerve related; breast pain; Pain in her chest that went through her left breast; This case was reported by a consumer via call center representative and described the occurrence of nerve pain in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced nerve pain, chest pain and breast pain. On an unknown date, the outcome of the nerve pain, chest pain and breast pain were recovered/resolved.   It was unknown if the reporter considered the nerve pain, chest pain and breast pain to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix and experienced pain in her chest that went through her left breast.  She went to the doctor and had an EKG that was negative.  She stated that they think it was nerve related and it resolved within 24 hours.   For tolerances of 2nd dose, refer case US2020075636, reported by same reporter for the same patient.
t105- 1 day following vax;rash (blister type) when they popped they spread all over genital area, stomach, chest, back began to eat away @ flesh;
Sore arm, knot (lump) at place of injection, chills, fever (101 degrees). These symptoms have all taken place within the last 36 hours.
This spontaneous report as received from a 64 year old female patient with unspecified blood pressure medication and no drug reactions and allergies refers to herself. She had shingles in May 2013 which had cleared up at the time of reporting. On 05-JUL-2013, she was vaccinated with a dose of ZOSTAVAX, subcutaneous in the left arm (dose, frequency, lot # and expiration date unknown). On 05-JUL-2013, the patient was vaccinated with a dose of ZOSTAVAX in the fleshy part of her left arm. After the injection she felt pain in that area, had swelling, and redness. That lasted about one week. There were no other symptoms. On an unknown date, she visited doctor's office and blood work test was performed (results not reported). No treatment was given for the events. At the time of reporting, the patient was recovered. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  An 83-year-old male patient received BNT162b2 (BNT162B2), in Feb2022 as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "bladder carcinoma in Situ" (unspecified if ongoing), notes: bladder carcinoma in Situ. The patient's concomitant medications were not reported. Past drug history included: Iodine, reaction(s): "known allergies: iodine".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 01Jul2022 to 06Jul2022.  Clinical summery: The event did not result in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating and congenital anomaly/birth defect.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As per available information the causality of the event Covid-19 and Drug ineffective with the suspect product BNT162B2 can not be ruled out.
This spontaneous prospective pregnancy report was received from a nurse practitioner (certified nurse midwife), refers to a 23 year old female patient. No medical history or concurrent conditions were reported. On 05-MAY-2014, the patient was vaccinated with her first dose of GARDASIL, 0.5 ml, intramuscular injection (strength and lot number not provided). Co-suspect or concomitant therapies were not reported. The patient received the first dose of GARDASIL while she was pregnant with an estimated date of conception on 17-APR-2014, LMP (last menstrual period) reported as 03-APR-2014 and EDD (estimated delivery date) on 08-JAN-2015. No adverse effects were reported. Patient sought medical attention through an office visit. At the time of the report, the pregnancy outcome was unknown. Additional information has been requested.
23 hours after the vaccine I began vomiting, I was very concern.  I was vomiting about 4 times an hour for 5-6 hours I couldn't even keep water down.  This was on top of all the normal side effects such as sore arm and body aches.  The following day, Sunday the 24th I was feeling much better just tired and has a sore stomach.  I'm very worried about getting the 2nd vaccine since I was so sick with the first one.
Patient reported reddish spots/rash at shoulder and back of shoulder recommended to see physician on as soon as possible basis.
Mild bell's palsy; Sore arm; A spontaneous report( was received from a 72 years old, female patient who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced events of sore arm and mild bell's palsy(facial palsy).  The patient's medical history was not provide .No relevant concomitant medications were reported.  ON 02-Feb-2021, prior to the onset of the events, the patient received their first dose of mRNA-1273 (lot: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 02-Feb-2021, post vaccination, the patient reported that her right arm was sore for a few days. No treatment information was provided.  On 09 Feb 2021, the patient has extensive dental work in one side as the dentist tried to put an implant in and was unable to.   On an undisclosed date, days following dental work, her lips on the left and right of her face were not matching. She stated that the rest of her face was fine.   On an undisclosed date, her dentist and primary care physician diagnosed her with an extremely mild case of Bell's Palsy caused by the extensive dental work.  The treatment received for the event included steroid injection.  The outcome of the events was unknown.; Reporter's Comments: Patient's dentist and primary care physician diagnosed her with an extremely mild case of Bell's Palsy caused by the extensive dental work.   Based on reporter's causality provided, the event is assessed as unlikely related to mRNA-1273.
Headache Light-headedness Hot/cold chills Sharp pains near lungs/pressure Heavier breathing Sluggish Felt like I was punched in the arm on first and second dose but worse the first time Achy body
This spontaneous report as received from a Registered Nurse refers to a unspecified number of patients of unknown age and gender. Medical history and current conditions were not reported. On an unknown date, 3 improperly stored doses of VARIVAX (Merck), 0.5 ml, subcutaneous (lot number and expiration date were not reported) were administered to unspecified patients. Concomitant medication was not reported. No adverse effects were reported. Additional information has been requested.
Information has been received from a physician concerning a child who was vaccinated with VARIVAX (Merck). Subsequently the patient developed herpes zoster. A zoster specimen confirmed recombination of vaccine strain and wild type varicella zoster virus in this patient. This is one of several reports from the same source.
Received her Flu shot Friday. Woke up Monday morning with pressure in her chest like someone was sitting on her chest and it felt like it was difficult to breathe. Felt fine and it was gone by Tuesday morning.
COVID-19; COVID-19; Dose Number 5; Moderna; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Jun2022 as dose 4 (booster), single (Lot number: FN2908) at the age of 53 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: EN6195), on 09Apr2021 as dose 2, single (Lot number: 0153) and on 30Nov2021 as dose 3 (booster), single (Lot number: FF2593) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 07Oct2022 at 08:15 as dose 5 (booster) single (Lot number: 053D224), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 07Oct2022, outcome "unknown", described as "Dose Number 5; Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: No other medication was taken in 2 weeks. Patient received Paxlovid Treatment from Jan2023 till Jan2023. Patient did not had Known allergies and no medical history was reported.  No follow-up attempts are possible. No further information is expected.
Following 2nd shot diarrhea mostly for 1 month following the injection, day 2-3 felt ill and didn't want to move much.  On march 28th still diarrhea but after lunch felt ill and progressively got worse then at 4:00 PM vomitting started and it wouldn't stop and after 5 hours went to emergency room at PVH.  They recommended I stay for a variety of blood, stool , virus tests.  Admitted for 2 nights, no tests confirmed anything.  It is my opinion this was from the COVID shot interacting with y compromised immune system-Doctors can't conclude this.
Patient was inadvertently given a 0.2ml dose of Moderna (for age 18+) instead of a 0.2ml dose of Pfizer pediatric. No adverse events at this point
Rapid heart rate, tightness in chest and forehead, chills, feeling of malaise, lasting about 3 hours, general weakness and lethargy continuing for about 24 hours after receiving vaccine.
Initally itching, redness+swelling @ site. (Icepack applied to injection site with hematoma) Followed by feeling dizzy, faint, lightheaded. BPS 186. Took Benadryl 25 mg. Approx 15 min later increase in feeling dizzy, faint, and also nausea with belching+general body tremors.
I was diagnosed with episcleritis of right eye. treated with steroid drops for almost 2 months and I still have it.  Very red & irritable and blurry vision at times in that eye.  Unfortunately, it got a little better with the drops but will not go away.  I stopped taking the drops about a week ago and my eye is terrible. I have never had this before in my life so this is a first!
Skin hurting Restlessness Fever Headache Shortness of breath Seeing flashes Malaise Muscle aches
shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information about medical history, concurrent conditions and concomitant medication use was provided. In 2017, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) as prescribed and/or administered by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to the patient's zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a physician for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX), the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was reported as not recovered/not resolved. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX). This is one of two cases concerning the same patient.; Sender's Comments:  US-009507513-1208USA007626:
This case was reported by a pharmacist via sales rep and described the occurrence of generalized rash in a adult patient who received FLUARIX QUADRIVALENT. In September 2015, the patient received FLUARIX QUADRIVALENT. On an unknown date, less than a month after receiving FLUARIX QUADRIVALENT, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was unknown. It was unknown if the reporter considered the generalized rash to be related to FLUARIX QUADRIVALENT. Additional details were received as follows: This case was not previously reported to anyone. The case was one of the 7 cases reported for adverse events experienced by the 7 patients vaccinated with FLUARIX QUADRIVALENT, at the same facility. This case was regarding the patient who experienced full body rash after the vaccination. The cases reported for other 6 patients were US2015137455 and US2015137458 (anaphylactic shock), and US2015137461, US2015137462, US2015137463, US2015137464 (redness and swelling at injection site). There were many employees were vaccinated at the same facility with the FLUARIX QUADRIVALENT, among them 7 patients experienced events.
Developed red bumpy rash and itching 3 days after vaccine was given at injection site and later spread over entire arm. On day 12 after vaccine, taken to dermatologist and started on Prednisone--symptoms better on day 14. Has appointment with allergy specialist on 10/21/02 for further testing.
pt recv vax 1MAR95 & devel hives;pt awoke 3AM & hands & forearms were swollen like sausages;tx DPH & then Pred;pt exp urticaria & angioedema;required ER/MD visit;
Patient experiences symptoms of a TIA around 8:15pm, they resolved on their own. She has experienced TIAs in the past. Her daughter encouraged her to be seen in the emergency room the following morning 8/12/21. She states the emergency room did a CT scan and labs and did not find anything and sent her home without a diagnosis. She followed up with her primary care physician who diagnosed this as being a TIA event.
Two days following vacciantion patient developed pink slightly raised rash to stomach, hip and under breast area.PAtient using over the counter costisone cream for treatment with much improvement. Rash present today.
Pt with tongue swelling, throat "closing" and near syncope/tunnel vision within 2 hours of receiving dose 1 of Moderna COVID vaccine. Treated with "antihistamines" at hospital. Pt states that she had a similar reaction 3-4 years ago when she received the MMR vaccine.   Symptoms: Angioneurotic edema(T783), DIZZINESS AND GIDDINESS(R42).
Pt had a normal menstrual period which started 4 days after her vaccine.  She had not had one for the prior 5 years!
Swollen, red area where varicella vaccine was given.  Warm to the touch & tender.