chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Serious neuropathy on both of my upper and lower extremities; Shingles; It's like there is a lightning bolt in my toes; Big flair up but it started to heal, on my spine and between my shoulder blade; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Serious neuropathy on both of my upper and lower extremities) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Triglycerides high and High cholesterol. Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced NEUROPATHY PERIPHERAL (Serious neuropathy on both of my upper and lower extremities) (seriousness criterion medically significant), HERPES ZOSTER (Shingles), PAIN IN EXTREMITY (It's like there is a lightning bolt in my toes) and ARTHRALGIA (Big flair up but it started to heal, on my spine and between my shoulder blade). At the time of the report, NEUROPATHY PERIPHERAL (Serious neuropathy on both of my upper and lower extremities), HERPES ZOSTER (Shingles), PAIN IN EXTREMITY (It's like there is a lightning bolt in my toes) and ARTHRALGIA (Big flair up but it started to heal, on my spine and between my shoulder blade) outcome was unknown.        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.   Patient took Acylclovir for 10 days for shingles.  Company comment: Based on the current available information which includes a temporal association between the use of the product and onset of the reported events, a causal relationship cannot be excluded. Some vaccines have been known to exacerbate latent herpes zoster .  Arthralgia is consistent with the product safety profile.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the reported events, a causal relationship cannot be excluded. Some vaccines have been known to exacerbate latent herpes zoster .  Arthralgia is consistent with the product safety profile.
The day of the injection I felt tired and a little sick but nothing major. The next two days I felt totally normal. On the 4th day after my injection (Wednesday, March 31st) I was lying down at 2PM because I was feeling strange. All of a sudden my feet and hands only got super cold, then cold and sweaty. I was lying with a heating pad and sat up to drink some water. I got super dizzy, couldn?t catch my vision. I tried to get up and walk to the door for some fresh air. Standing and walking felt like I was super drunk... couldn?t get my balance. That happened for about 30-45 minutes. I was super nervous as well with adrenaline pumping. I went to urgent care after about an hour and a half when I felt it was safe to drive. They didn?t know why that happened or what it was.
injection site is red, itchy, and warm to the touch.  This appeared a week and a half after the injection.
Patient was given the Pfizer Covid-19 ADULT dose instead of the Pfizer Covid 19 PEDIATRIC (PEDS) dose. After 24 hours, no adverse reaction or side effects reported.
Moderna COVID-19 Vaccine EUA    Inability to eat (nausea), unpleasant taste, extreme weakness, inability to think appropriately (unable to recall words, slow thought process), diarrhea -- all occurred for two days and have resolved themselves without treatment; still weak but am increasing liquids, salts, immodium (not today), frequent rests, cancelling Physical Therapy and private clarinet instruction
Cellulitis R thigh, Augmentin ES BID X 10 days.
This spontaneous report as received from a healthcare worker (C.M.A.) refers to a 68 years old female patient with hypercholesterolemia and rosacea. The patient's medical history included shingles. The patient had "no known allergies" to drug. On 07-SEP-2012 the patient was vaccinated with a single dose of 0.5 ml PNEUMOVAX23 (lot # not reported) intramuscularly into the left deltoid. It was reported that the patient also received a dose of TDAP into the right arm during the same visit. On 10-SEP-2012 the patient sought for medical attention by calling the practice to report that she was experiencing redness, blotchiness, and pain at the PNEUMOVAX23 injection site, and a swollen left hand. No treatment was given. The outcome was reported as not recovered. Additional information has been requested.
Whole body severely aches, muscle weakness headaches, pins and needles over whole body tired on and off every joint aches.
Information has been received from a certified medical assistant concerning a 13-year-old female with no pertinent medical history and no drug reactions/allergies who on 12-MAR-1996 was vaccinated with a dose of Varivax. There was no concomitant medication. On 29-MAR-2006 the patient developed 100-150 lesions and was treated with acyclovir. There were no lab diagnostic studies performed. The outcome was reported as recovered. There was no product quality complaint. Additional information has been requested.
Vision in both eyes has become distorted. In a manner which is difficult to explain. The main concern though is my Right eye which has been affected dramatically by a dark spot in my vision out from my right eye. I noticed this upon waking up the morning of 11/17/2021 at 08:00  I am also suffering severe headaches. The body chills and Covid sypmtoms  lasted only unitl today 11/18/21 though my vision and headaches persist to be an issue.
I woke up around 2am with chills, an intense headache and body aches. I have pain at my injection site.
after injection site became very itchy, hrs. later warm, sore and hard. the next AM lymph node under rt. arm was swollen and tender and still itchy. 2 days after injection lymph node still tender and somewhat swollen
Afternoon after immunizations complained of raised bumps on back. Lasted until next day. Did not report bumps until day 3 when returned for PPD reading.
diffuse arm swelling with pitting in wrist and elbow with pain, no symptoms of axillary lymphadenopathy.
Pt developed vesicular rash on erythematous base 11 days after varicella vaccination.
I had a breakthrough case of Covid-19 sore throat with a cough that lasted quite a bit, with head and chest congestion, fever and chills for about 36 hours I was prescribed an antiviral Molnupiravir.
sores in nose, mouth; sores in nose, mouth; sore throat; chapped peeling lips; chapped peeling lips; pimple type spot close to his/her lip; chills; suspected vaccination failure; slight outbreak; injection site swollen; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, injection site swelling, sores mouth, nasal ulcer, sore throat, chapped lips, peeling lips, papular rash and chills. On an unknown date, the outcome of the vaccination failure, shingles, sores mouth, nasal ulcer, sore throat, chapped lips, peeling lips and chills were unknown and the outcome of the injection site swelling was recovered/resolved and the outcome of the papular rash was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, injection site swelling, sores mouth, nasal ulcer, sore throat, chapped lips, peeling lips, papular rash and chills to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated he/she just recently had the second vaccination and asked if anyone had what may appear to be a slight outbreak from it. The patient stated he/she ended up having sores in his/her nose, mouth, sore throat, very chapped peeling lips and a pimple type spot close to his/her lip that came and went away and then came back again. The patient had chills the day after and the injection site stayed swollen for 4 days. The patient stated he/she did not have a cold to cause these problems. The patient was just curious if anyone else had this and he/she was okay if it was; it was much better than getting full-blown shingles for sure. The follow-up would not be possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation regarding shingles was not provided.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms and unwell. On an unknown date, the outcome of the influenza-like symptoms and unwell were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms and unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. This case was reported by the patient's friend. The reporter was calling for medical information and availability of SHINGRIX (refer case US2018151043). While discussing this reporter mentioned her friend experienced flu-like symptoms and was really ill. The reporter was not asked further probing details since she just mentioned that in conversation and that was not the reason for her calling. This case has been linked to case US2018GSK157010, reported by the same reporter.
Cold sores on inner lip after 24 hrs -> VALTREX. Local reaction w/ erythema, induration after 2-3 hrs. Diarrhea after 48 hrs.
My injection site is very swollen and hard to the touch. It is also very itchy, warm, and red. I have just been cleaning it and taking Tylenol and it has not effected the reaction.
Initial report was received on 11 October 2010 from a health care professional. A 12 year-old male patient with a past medical history of diabetes and asthma, had received FLUZONE SV 2010-2011, lot number UH184AA (route and site of administration not reported) on 09 October 2010 at 11:00 AM and "four hours later" (about 3:00 PM), experienced a swollen face and a break out of hives on his chest, neck and arms. The patient was treated with BENADRYL (dosage not reported). Concomitant medications included insulin, cetirizine, prednisone and albuterol (as needed). On 11 October 2010 the patient's hives had "disappeared" and his outcome was reported as "back to normal". The patient had received a H1N1 vaccine (manufacturer Novartis) on 19 November 2009 with no adverse event. No further information was available at the time of this report. Reporter for this case is same as for case 2010-05869. Documents held by sender: none.
Heart attack; This is a spontaneous report from a non-contactable other HCP via Medical Information Team. A 58-year-old male patient received received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on unspecified date as an Unknown, Single Dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that another person had a heart attack on the freeway with less than a month of getting the Pfizer vaccine. The reporter stated this patient was a 58-year-old male. The reporter stated, he would never get another one, he hopes to God his son never gets one either, he was telling everyone they should take Loroquine (reporter does not had spelling), not even sure if available. The outcome of the event was unknown.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Rash raised, red, warm, and itchy in area covering about 7 cm underneath injection site. This started on Feb. 2.  Also had fever of 100 degrees, body aches, headache for about 36 hours, it started 12 hours after I received the vaccine.
Significant bleeding at time of vaccine administration on 6/24/2022; Mother called 6/29/22 to report bruising, discoloration in right arm from elbow to mid arm with mild to moderate swelling after vaccine.  NP directed patient to local PCP for evaluation of potential vaccine reaction vs tissue injury. PCP noted "injection site to be distal to the right deltoid with probable muscle injury and extravasation. Pulses palpable, cap refill within normal limits,. Muscle strength normal". Recommended cold compresses and serial weekly surveillance until resolution.  Note:  unable to determine what dose number in the series because pt is from another state.
Mild allergic reaction in first 30 mintues; swollen glands; ears clogging; puffy eyes; sore throat; itchy skin random spot and at injection spot; turned red all over; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received the first dose of BNT162B2 (Pfizer BioNTech COVID-19 vaccine, Solution for Injection, Batch/Lot number: EN6284), via an intramuscular route in arm left on 17Mar2021 at 17:30 (at the age of 34-year-old), as a single dose for covid-19 immunization at Health Department. The patient medical history included appendix removed, surgery in 2004, gall bladder removed, surgery in 2003, colon polyps, surgery colonoscopy in 2015 and acid reflux, slow emptying emptying test (2000) at the age of 12 (ongoing). Allergies to medications, food, or other products: Shellfish, leviquinn, augmentine, environmental, drug and food allergies for which patient has taken allergies shots 1997 to 2000 and prescribe treatment of meds, allergies that induce asthma, no glad bladder and appendix acid reflux Ibs, reaction to vaccine and allergy. Concomitant medications included Ibuprofen for tooth pain, fexofenadine hydrochloride (ALLEGRA), montelukast sodium (SINGULAIR), Inhaler for reaction to vaccine and allergies, everyday (No inhaler unless needed), orally and all were ongoing. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 17Mar2021, the patient experienced mild allergic reaction (reaction to shot) in first 30 minutes (reported as onset time: 20mins, 24 hours after), swollen glands, ears clogging, puffy eyes, turned red all over, sore throat, itchy skin random spots and at injection spot. She had allergic responses to both shots given. Therapeutic measures taken as a result of the events included doctor onsite advised dosing with 3 bendryls, through mouth 1 dose before and 2 after given shot stayed 30mins and monitored her. The most side effect became less after 1 hour and dosing with 3 bendryls 1 dose before and 2 after given shot. Patient had all side effects reported and were severe. Lasting 4 days after 1 shot. The outcome of the events was recovered on an unspecified date in Mar2021.  No follow-up attempts are possible. No further information is expected.
Bilateral lymphedema in fingers, hands, wrists, toes, feet, ankles, knees.
Site: Swelling at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypertension-Medium, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Systemic: Vomiting-Severe, Additional Details: immediatley after recieving first dose, patient beganing showing signs of allergic reaction. Patient began vomiting and feeling nauseaus immediately after.
PROQUAD was given instead of MMR, so patient got 2 doses of varicella vaccine at the same time
Received Zostavax in left arm on 9/13/12.  Developed itching same day, gradual increasing redness and swelling "like a big hive > 15cm." Had clear weeping from affected area at the time.  Relief with cool packs, reduced over time.  Has had continued generalized itching since, worse in the evenings.  Initially tried Loratadine daily for 8-9 days, and hydrocortisone bid without notable relief. This weekend noted has continued redness at the site of the injection.  On exam: 2.5 x 3cm pink blanching oval on left tricep without edema, erythema or induration.  Not tender to palpation. Take Hydroxyzine 12.5-25mg at bedtime daily for one week.  May apply hydrocortisone 1% OTC to affected area three times daily.   If symptoms persist, follow up with PCP or dermatology within 1-2 weeks.
Skin hurt to touch chest tightness; Cough; Left lung pain; Tired; Clamy; Sleepy; Felt like flu; Skin hurt to touch; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 13Mar2021 at 12:00 hours (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (copd). Concomitant medications included pain meds (unspecified). The patient has no allergies to food, medication or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021 the patient experienced skin hurt to touch, chest tightness, cough, left lung pain, tired, clammy, sleepy and felt like flu. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the events skin hurt to touch, chest tightness, cough, left lung pain, tired, clammy, sleepy and felt like flu were recovering. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 03April2021 (at the age of 57-year-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
developed back pain on 9/17/2021. Admitted to hospital on 9/19 through 9/25.  Denies any fever, cough or SOB. Has now been discharged to home and has no symptoms.
SKIN LACERATION; ACCIDENTAL EXPOSURE. Information regarding Flumist 2003-2004 Formula (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a healthcare professional regarding a nurse who was administering the vaccine and experienced the syringe breaking  lacerating her thumb. A nurse, who was administering the vaccine, experienced the syringe breaking and lacerating her thumb (skin laceration) (accidental exposure). The reporter indicated that "she is fine now." No additional information was available at the time of this report.
I contracted COVID-19 on 06/18/2022 with symptoms of headache, loss of taste, fever of 100.9, chest congestion, sore throat, sneezing, cough, muscle aches, diarrhea, and fatigue. I was prescribed ROBITUSSIN AC for my cough on 06/27/2022. I was ill for 12 days before my symptoms began to resolve. I am experiencing lingering fatigue.
Information has been received from a pharmacist concerning a 20 month old male who on 3/4/05 was vaccinated in the left thigh with a 0.5ml dose of varicella virus vaccine live. On 3/15/05, 12 days after the vaccination, the patient experienced penile swelling and injection site swelling. Medical attention was sought and the patient was seen by a pediatrician and a urologist but not admitted. He was being treated with an antibiotic. it was reported that on 3/16/05, his penis appeared huge, almost priapism and seems has a cellulitis starting. The outcome was reported as unknown. No product quality complaint was involved. The reporting pharmacist considered the adverse experiences to be other important medical events (OMIC). Additional information has been requested.
I experienced a breakthrough case of COVID-19 with fatigue, congestion, fever and cough.
Monday noc devel redness & swelling in rt leg where pt recvd DTP is painful & unable to bend; Not aware of pt having fever has been giving APAP; Tuesday eve noted rash-red on back-itchy; taken to MD for eval;
Headache; Diarrhea; Vomiting; she is sick; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for herself. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Apr2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient said that she just got Covid vaccine a couple of hours ago and that she was vomiting and its coming out the other end, she had vomiting and diarrhea. She further stated after getting the Covid shot about 2 hours ago, she experienced vomiting, diarrhea and headache on 21Apr2021. Some other person (details unavailable) came on phone and mentioned the patient got the vaccine shot and she was sick, experiencing vomiting and diarrhea and asked if this was normal. The person mentioned the experience was terrible and wanted to know if she needed to go to the hospital and if this was a normal side effect. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 72-year-old male patient who received SHINGRIX for prophylaxis. In October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site swelling, injection site pain, diarrhea, red rash and itchy rash. The patient was treated with Antibiotics (Brand Names Not Known) and topical Steroid Cream. On an unknown date, the outcome of the injection site swelling, injection site pain and diarrhea were unknown and the outcome of the red rash and itchy rash were not recovered/not resolved. It was unknown if the reporter considered the injection site swelling, injection site pain, diarrhea, red rash and itchy rash to be related to SHINGRIX. Additional information was reported as follows: The patient's wife reported the case. The patient was vaccinated with the second dose of SHINGRIX, approximately three weeks ago before the date of reporting. The patient experienced injection site swelling and injection site pain and diarrhea. The patient also experienced rash on his back and legs that was red and itchy. The patient was treated by dermatologist with antibiotics and steroid cream but the rash and itchiness had not resolved. The reporter requested to remain anonymous and declined to follow up with the physician. Consent to follow-up was not provided.