chrisvoncsefalvay/vaers-outcomes huggingface dataset:
very large sores over a large area from the belly bottom to the backbone on the left side / about 10 inches high from my waist up; pain; can't get dressed or drive; got  both Shingrix vaccines "like 3 years ago." / Shingles on June 2020/ suspected Vaccination failure; PHN that has last for 9 months; "really bad" case of Shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (received 10 years before the date of reporting).   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. In June 2020, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and post herpetic neuralgia. On an unknown date, the patient experienced skin ulcer, pain and activities of daily living impaired. The patient was treated with opioids {nos} (Opioids). On an unknown date, the outcome of the vaccination failure, skin ulcer, pain and activities of daily living impaired were unknown and the outcome of the shingles was recovered/resolved and the outcome of the post herpetic neuralgia was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingrix and Shingrix. It was unknown if the reporter considered the skin ulcer, pain and activities of daily living impaired to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient himself. The age at vaccination was not reported. The patient received both Shingrix vaccines like 3 years before the date of reporting. The patient received the first dose in the right arm and the second dose in the left arm. The patient did not provide the dates when he got vaccinated but states that he got the second dose around 2 months plus the first dose, in the proper spam of time. The patient experienced a really bad case of Shingles on June 2020 that lasted about a month. The patient also reports having very large sores over a large area from the belly bottom to the backbone on the left side, and about 10 inches high from his waist up.  The patient stated that he has PHN that has last for 9 months. The patient was taking opioids for pain, but they don't really help. He could not get dressed or drive. The patient states he was receiving signals to the nerves and a Spinal peripheral stimulator for the PHN. Patient states that PHN was worse than Shingles. Patient states he has not recovered from PHN. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown. All information was not available. Dates of vaccines and lots and expiration dates were not available during the call but reporter states that this information could be obtained. The reporter consented to follow up.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown ages and gender. On an unknown dates the patients were vaccinated with a dose of ROTATEQ (dose, route, and lot number not provided) that was improperly stored and exposed to temperatures outside the storage range in the prescribing information. No adverse effect were reported. This is one of several reports from the same source. Additional information has been requested.
Client called 8/7/23 to report lightheadedness,  diaphoresis, and a low grade temp of 99 starting late on 8/4 after vaccinations. On sat 8/5 she experienced N/V, chills, HA, fatigue and aching. She did not take her temp. She drank fluids and took OTC tylenol alternating with ibuprophen however stated it did not help symptoms. Chills, HA and fatigue a "little better" 8/6 in the am however returned in the PM. Mon, 8/7 she still experience same symptoms and took her temperature, she reported 106F. She called the office to report the symptoms and felt like she should go to the ER. Advised if she felt like she should go then proceed to ER. Reported in the ER her fever was 105.6  her lab work showed high liverenzymes. Stated she was admitted for a consult with infectious disease and GI specialist due to elevated liver enzymes and fever. Fever "broke" on the 4th day of hospitalization.  Remained in hospital to monitor liver function. Requested lab results and discharge summary from pt. Still waiting on those reports.
This spontaneous report concerning a 60 year old female patient was received from her husband. The patient had no  pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies. On 20-DEC-2016, the patient was vaccinated with a dose of ZOSTAVAX Injection (strength, dose, route of administration, lot number and expiration date were not reported) for prophylaxis. On 26-DEC-2016, the patient experienced shingles. No product quality complaint (PQC) was involved. At the time of the report, the patient had not recovered from the shingles. The causality assessment between the event and the ZOSTAVAX was not reported. Additional information is not expected as the reporter did not provide consent for follow up.
This is my booster 3rd shot. I felt achey and hot which is no big deal. My injection site turn hard and red and swelled to a large lump about the size of a lemon and my arm is swollen. Redness spreading. I have not gone to the dr. Im waiting to see if it dissipates. If not i will go to the dr.
None  Patient was underage when recieved the vaccine. Janssen J&J only approved for adults 18 years and older. Mother notified and informed to reached out to her primary health care doctor. Mother was also encouraged to sign up for the v-safe mobile sheet.
Information has been received from a physician concerning a female who was vaccinated with a dose of Gardasil (lot# not reported). The patient was given the vaccine on the same day as a Tuberculosis test which was positive. Since the patient had an initial positive TB test, a second more through TB test was given in which blood was drawn and the results were negative. No other information was provided. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report previously submitted on 4/13/2007. Information has been received from a physician concerning a female who was vaccinated with a dose of GARDASIL (lot# not reported) on 9-Feb-2007. The patient was given the vaccine on the same days as a Tuberculosis test (lot# C 2008AA) intradermal in the left arm which was positive. Since the patient had an initial positive (TB interferon). TB test (14mm), a second more thorough TB test was given in which blood was drawn and the results were negative. No other information was provided. No product quality complaint was involved. Additional information has been requested.
Mother said child awoke at approx. 10:45pm 6/21/12 felt "hot". He began to shake. Lasted approx 30 seconds. After he had seizure mother gave him TYLENOL. As of 11am 6-22-12 he had  had only one episode of "shaking". History of one febrile seizure in the past on 5-13-12. Feeling tired & itchy but playing. No loss of consciousness.
Not sure exactly when it started but the next morning one leg had about 6 inch swollen hard red and hot area other leg about a 1 inch hot swollen area-one vaccine in each leg on tdp one chickenpox I think she is sensitive or allergic to the preservative or base of it never before has had a reaction called advise nrse she said it is normal, but not for my children ever before.
Severe joint pain all over body all the way to ankles. Like arthritis pain. Barely could move in bed to get up. Took ibuprofen and tylenol.
Patient experienced swelling, pain, itching, and redness on the entire upper arm. Swelling decreased over the next 2-3 days. redness still evident 3 days later.
This patient is a vaccinated  male who travels throughout the country and overseas on business. Due to the travel he is frequently tested for Covid. He indicates having clinical disease with the typical symptoms in December through early January. He was able to manage at home and did not require admission or intensive services. A family member owns a device which he used for respiratory support. He was vaccinated for Covid with his second dose 7/6. He has no known exposures. He currently has no symptoms consistent with Covid   He presented yesterday with a complaint of right lower quadrant abdominal and flank pain. Evaluation in the emergency room identified pancreatitis hyperlipidemia and laboratory consistent with DKA. With his triglycerides greater than 7500 a Quinton was placed in the right IJ position and plasmapheresis performed. Insulin drip and support was administered. He feels better today. Intravenous Ancef and Flagyl were administered for support.
sore throat; felt "crummy".; delayed reaction of hot spots around the injection site; red injection site; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), MALAISE (felt "crummy".), VACCINATION SITE WARMTH (delayed reaction of hot spots around the injection site) and VACCINATION SITE ERYTHEMA (red injection site) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat), MALAISE (felt "crummy".), VACCINATION SITE WARMTH (delayed reaction of hot spots around the injection site) and VACCINATION SITE ERYTHEMA (red injection site). The patient was treated with IBUPROFEN at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (sore throat), MALAISE (felt "crummy".), VACCINATION SITE WARMTH (delayed reaction of hot spots around the injection site) and VACCINATION SITE ERYTHEMA (red injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported
Bell's Palsy I woke up the next morning, 7/26/22, with a droopy left eyelid.
These included soreness abd swelling at the injection site, swollen lymph nodes in the armpit of that arm that received the injection and tingling/numbness in the hand of the arm that received the injection; These included soreness abd swelling at the injection site, swollen lymph nodes in the armpit of that arm that received the injection and tingling/numbness in the hand of the arm that received the injection; These included soreness abd swelling at the injection site, swollen lymph nodes in the armpit of that arm that received the injection and tingling/numbness in the hand of the arm that received the injection; These included soreness abd swelling at the injection site, swollen lymph nodes in the armpit of that arm that received the injection and tingling/numbness in the hand of the arm that received the injection; These included soreness abd swelling at the injection site, swollen lymph nodes in the armpit of that arm that received the injection and tingling/numbness in the hand of the arm that received the injection; This spontaneous report was received from a merck employee regarding to a female patient of unknown age. No information regarding the patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was provided.  On 05-JUN-2023, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date in June 2023 the patient experienced soreness and swelling at the injections site (vaccination site pain, vaccination site swelling), swollen lymph nodes in the armpit of that arm that received the injection (lymphadenopathy) and tingling, numbness (hypoesthesia, paresthesia) in the hand of the arm that received the injection. At the time of reporting, the outcome of the above events were not provided.  The causal relationship between the aforementioned events and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not reported.
Motor tics of bilateral arms started 3 days after the second COVID vaccine.  Have continued constantly except when sleeping.
Rash, distributed, head, face, neck, down back and arms (started at head), began 2 weeks later.  Itches, burns, some turned to blisters.  Said it looks like a horrible sunburn.  Saw provider and provider had no other change so said to call it in to Regulatory Authority  as a vaers to vaccine.
Approx. 14 hours, post vax, developed painful swelling of left upper arm below injection site. Approx. 24 hours, post vax, same area became reddened, hot to touch and pruritic. (6cm X 8cm approx. size), triangular-shaped area of erythema and swelling on left upper arm below left deltoid injection site with tenderness and pain on palpation. Has a firm palpable induration at left deltoid needle site.
pt recv vax 23FEB96 & 10APR97 pt devel chickenpox w/4 or 5 lesions;it was reported that the pt illness was mild on 11APR97;
After receiving the second dose of the Modernal vaccination I started experiencing severe headaches.  These headaches continue 3 weeks later.  Headaches described as sharp stabbing pain on the left side of my head with intermittent pressure above my eyes.  I have been taking ibuprofen 800 mg every day since 3/31/2021.  At times of headaches I experience dizziness, lightheadedness and at times feeling confused?
Patient behind on immunizations, always got them one at a time. In an attempt to catch up, 3 given at one time and patient developed urticaria.
No adverse event to date. Vaccine given in error 11 days under the age of 18.
Pt received vaccine and was seated in observation area. Mother stated daughter "was not doing well". Upon checking the patient, she was staring blankly ahead, non-responsive to verbal commands, and initially non responsive to physical stimuli. Pt began to regain consciousness and awareness of surroundings. Was given water and EMS contacted. Pt remained shaky and was escorted in mobile chair by EMS to ambulance for vital assessments. Mother returned later to say tat daughter had recovered without need for further medical intervention and that initial assessment was a vasovagal response.
Fever of 103.1 throughout the night and next day, body chills, body aches, vomiting, dizziness
Two patient / late for the second dose / first dose / on December 2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose of Shingrix received in December 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient's identifiers, LOT number and expiration date was not provided for the first dose. The reporter did not consented to follow up. This is 1 of the 2 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR129763: reporter. Patient #2 of 2.
got their first dose of the Moderna vaccine on 23Feb2021 has not gotten their second dose yet; This spontaneous case was reported by a pharmacist and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (got their first dose of the Moderna vaccine on 23Feb2021 has not gotten their second dose yet) 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 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (got their first dose of the Moderna vaccine on 23Feb2021 has not gotten their second dose yet). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (got their first dose of the Moderna vaccine on 23Feb2021 has not gotten their second dose yet) 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.   No concomitant medications were reported.   No treatment information was provided.   Reporter did not allow further contact
This spontaneous report was received from a physician, it refers to a 12 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions, allergies or concomitant medications. On 20-MAR-2018, the patient was vaccinated with the first dose of GARDASIL 9 (lot N021732, expiration date 01-FEB-2020), for prophylaxis (dose and route of administration were not reported). On 20-MAR-2018, after receiving 1st dose of GARDASIL 9, the patient, who was seated in a chair at the time of vaccination,  passed out (syncope), it was also reported that the patient fall back in chair and looked pale in color. The physician further reported that her heart rate, respiratory rate were within normal limits and after 20 minutes of observation was discharge to come. At the reporting time the outcome of the events was reported as recovered on 20-MAR-2018. The reporter did not assess the causal relationship between therapy with GARDASIL 9 and the events.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of   in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-010096 (E2B Linked Report).; Sender's Comments:  MOD-2021-010096:same reporter, different patient
Patient went swimming directly after receiving the shot, during which time she felt fine. Upon finishing, her arm began to stiffen and throb with pain. Patient could not move her arm at all.  The stiffness worsened to the point where she could not remove her jacket when she got home.  RPh followed up with the patient the next day: pain had subsided but stiffness persists and patient cannot lift her arm at all.
Information has been received from a licensed practical nurse concerning a 5 year old female with no medical history or allergies who on 21-MAY-2008 at 1120 was vaccinated subcutaneously with the second dose of VARIVAX (Merck) in the left arm(Lot# 660217/0167X). There was no concomitant medication. On 23-MAY-2008, the parent called the office to report that the child had an injection site reaction and was scratching her arm. When seen in the office, the injection site was red, hot and hard with possible cellulitis. An antibiotic was prescribed. The outcome of the events was unknown. The patient was seen in office to sought medical attention. Follow-up information was received concerning the patient was starting scratching the site and it opened and started to drain, arm was red, warm and tender last 1-2 days. Upon assessment doctor of medicine (MD) noted site as red raised, warm lesion with central umbilication. The MD prescribed AUGMENTIN 600mg/5ml x 7 days. Additional information has been requested.
Site: Itching at Injection Site-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Tachycardia-Mild, Additional Details: EMS was called and patient stated to feel a little better.  First responders recommended patient be seen at hospital and she left premises under their care.
"Covid arm" rash at injection site, with nausea, chills, fever, body aches, and slight cough. Today I still have the rash, some nausea and body aches.
Experienced anaphylaxis. Similar to what I experience for peanuts.   Symptoms: Difficulty swallowing, indigestion, high pulse
no additional adverse event; the patient was inadverentently administered a dose of Proquad and Varivax; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 29-JAN-2020, the patient was inadvertently vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot # S019461, expiration date 24-JUN-2021 and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot # S021619, expiration date 09-JAN-2021 (for both vaccines dose and route of administration were not reported), for prophylaxis. The vaccines were diluted with sterile diluent. No additional adverse event was reported. The outcome of the events was unknown.
Large red ring around the injection site still there after 48 hours, severe chills, headache and body aches, tingling mouth  and some tightness of throat immediately after injection
10/26/18   Rec'd 2nd injection of Recombinant Zoster Vaccine. After 1hr: tingling left arm and hand, numb rest of day. Iced several times during day. After 3hrs: dizziness and nausea. Slept 3 hrs, felt better. After 12hrs: at bedtime: chills, head ache, body aches in joints. 10/27/18   Woke with headache, chills. Continued icing arm during day, very sore, red & swollen at injection site. By mid-day injection site very red and hot to the touch. Felt like a severe bruise. Rested during day, felt normal late afternoon. 10/28 and 10/29/18:  Feel normal. Injection site very red, painful like a bruise, very itchy. Still icing periodically.
This spontaneous report as received from a pharmacist refers to a 26 years old patient with vaccination. The patient was vaccinated with M-M-R II. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced had a negative titer following vaccination with M-M-R II on 11/30/2012. No treatment information was reported. The outcome of had a negative titer following vaccination with M-M-R II is unknown. No other information to report. Additional information has been requested.
Per patient, could not breathe, tongue had swollen up; went to ER. The discharge summary states angioneurotic edema.