chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Got Shingrix, got shingles/Suspected vaccination failure; Shingles every 4 months; This serious case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a 48-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Got Shingrix, got shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles every 4 months). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-APR-2023 The patient had already been vaccinated with Shingrix. The patient had been experiencing shingles episodes frequently (around every 4 months). This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The reporter did not agree to follow up from GlaxoSmithKline.
Local injection site reactions consisting of erythema/in size, maybe 1cm; Local injection site reactions consisting of induration/in size, maybe 1cm; Local injection site reactions consisting of significant pruritus/itching; This spontaneous case was received on 09-Sep-2023 from a physician (consumer) (reference number: SEQW23-02125) and concerned a 67-year-old, male patient.  The patient's medical history and concomitant medications were not reported. The patient's historical vaccines included annual flu vaccinations for over the past 20-30 years without any adverse events (AEs).  On 06-Sep-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; anatomical location: arm; dose, route of administration, and indication: not reported). The batch number was not reported.  On the same date, after receiving Flucelvax Quadrivalent, the patient had local injection site reactions consisting of erythema, induration, and significant pruritus. The patient had attached a photo of the patient's wife's arm. The patient's was significantly smaller in size, maybe 1cm, but still itching.  At the time of initial reporting, the patient had not recovered from all events. As reported, the patient was three days out and still had the reaction.  The reporter did not provide a causality assessment. As reported, this was the first time receiving this vaccine. The patient read product information (PI) and knew that AE rates were comparable to the comparators in trials, but the patient wanted to alert to these two personal cases.  This case was assessed as non-serious.  This case is linked with the case 202303957 (the same reporter).  Company comment: The events of 'vaccination site erythema', 'vaccination site induration' and 'vaccination site pruritus' are assessed as possibly related to Flucelvax Quadrivalent due to plausible temporal relationship.; Sender's Comments: The events of 'vaccination site erythema', 'vaccination site induration' and 'vaccination site pruritus' are assessed as possibly related to Flucelvax Quadrivalent due to plausible temporal relationship.
2 days post vax pt became ill w/fever & fatigue w/fever reaching 102.8 on 2nd day;pt was able to reduce fever w/fluids & did seek med care;tx w/floxin for UTI;
Information has been received from a nurse concerning a 13 year old female who on 24-JUL-2007 was vaccinated with a first dose of Gardasil vaccine. On 24-JUL-2007, the patient felt dizzy. Unspecified medical attention was sought. At the time of the report the patient's outcome was unknown. Additional information has been requested.  01/07/08 This is in follow-up to report(s) previously submitted on 11/14/2007. Initial and follow-up information has been received from a medical assitant concerning a 13 year old female with no pertinent medical history who on 24-JUL-2007 at 9:45 am was vaccinated intramuscularly into the left deltoid with a first dose of GARDASIL (Lot #654272/0319U). On 24-JUL-2007 the patient became lightheaded and faint. The patient did pass out for a brief time. There were no laboratory or diagnostic tests performed. On 24-JUL-2007 the symptoms resolved and the patient was dismissed in stable condition. Additional information is not expected.
Pt developed rash like bumps up and down left leg with stiffness around the site of injection.
When I woke up on Sunday, I felt dizzy and when I tried to get up, I lost my balance. After that I don't remember anything except that I was laying down on my bed and that I had fainted.
coughing; Her ribs are still a little sore today; This is a spontaneous report from a contactable Consumer (patient herself). A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported, Expiry Date: Unknown), via an unspecified route of administration on 17Jul2021 as single dose for COVID-19 immunisation (Age at Vaccination was 69 years). The patient's medical history included diabetes, High blood pressure, Hiatal hernia, vertigo, COPD, hypertension, cardiac and asthma (family history). Concomitant medications included Insulin and Aspirin (Acetylsalicylic acid) taken for cardiac disorder. It was stated that, prior vaccinations (within 4 weeks) were she doubts that seriously but, can't say for sure. On 26Jul2021, it was reported that, the patient experienced she was been into have little bit of coughing, she was having some coughing and her ribs are still a little sore today. No therapeutic measures were taken as a result of events. She did not visit Emergency Room or Physician Office for the events. The seriousness of the events was considered as non-serious. The outcome of the event coughing was unknown and for her ribs are still a little sore today was not recovered.  Follow-up attempts have been completed and no further information is expected. Lot/batch number cannot be obtained.
subconjunctival hemorrhage In the right eye, and a small bump with a little white dot
flu; developed a fever; Initial information was received on 15-Nov-2020 regarding an unsolicited valid non-serious case from a non-health care professional/consumer (patient's son) via social media.  This case involves a patient of unknown age who developed a fever (pyrexia) and Flu (Influenza), when patient recieved Influenza Vaccine.  Medical history, medical treatment, past vaccination and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown), following vaccination reporter's mother went to her doctor fine no signs of anything wrong according to her doctor a check that he made before administering the flu shot shortly afterwards at home she developed a fever (pyrexia) called the doctor he asked to come right in he examined her took swabs then after reading told her she had the flu (Influenza). Reporter stated (information not hear say because I took her to the doctor both times and I still have the documents which state his findings so before you post a bogus claim that the flu shot does not give you the flu get real facts or do more research)  Other relevant laboratory test were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the events were unknown.  There will be no information available regarding batch number in this case.
little bit of cough left; Tested positive for COVID19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID19) and COUGH (little bit of cough left) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID19). On an unknown date, the patient experienced COUGH (little bit of cough left). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID19) and COUGH (little bit of cough left) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Information has been received from a 62 year old female patient with no pertinent medical history and no drug reactions or allergies who in September 2010 had received a tuberculosis skin test. On last Friday afternoon on 21-JAN-2011, the patient was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # and expire date not reported), subcutaneously. There was no concomitant medication. Patient stated that on 22-JAN-2011 within 24 hours from receiving ZOSTAVAX (Merck), she developed an itchy rash on her arm and her back and then she realized there were a few poxes on her back and one on her arm. Patient mentioned that her back pox had gone away but the one on her arm was dime sized, raised and very itchy. There were no laboratory diagnostics studies performed. The patient sought unspecified medical attention. No treatment was given to the patient. At the time of the report, the patient had not recovered. Additional information has been requested.
Starting the day after receiving the vaccine, I ended up receiving my flu vaccine. Right after receiving the flu vaccine, I got dizzy "as if I had spun really fast in a room". I went home and took a clonazepam. I took a rest and once I woke up it was gone.
patient was given hpv vaccine (im) first in right arm, then MMR vaccine (sc) in left arm. syncopy occurred shortly following administration of MMR vaccine. patient recovered after a few minutes.
On 15 Aug 21 at approx 2000 I had tightness in the chest, shortness of breath (SOB) , mild fatigue, and muscle pain in the right shoulder, legs and back.  On the 16 Aug 21 at approx 0930 while at work the symptoms got worse so I went home.  My PCP who told me to go to the Emergency Room.  I did not go.  I stayed at home in the bed.  On the 19 Aug 21 the tightness and (SOB) resolved; however, the fatigue got worse along with exhaustion, sore throat and a pounding headache.  At 1500 I saw  NP for clinic.  He ordered Loratadine 1 x a day and Butalbital/Acetaminophen/Caff 1 q 4 hrs prn.  I still have a headache.
This case meets vaccine breakthrough criteria review. SxS include fever and weakness, SOB, loss of appetite
One week after receiving vaccine site became itchy with small bumps. Site is growing increasingly red and swollen and itchy. General feeling of tiredness, not well.
Redness, swelling, body aches & malaise redness spread down her arm - developed cellulitis. Antibiotics given.
Patient was incorrectly administered the pediatric formulation (0.2 ml) rather than the adult formulation by our nurse, although the patient is 13 years old.    The error was discovered upon entry into the statewide vaccine database when we noted the lot number and volume correspond with the pediatric formulation. Guidelines state that the dose should not be repeated   We contacted the parent to notify her of the error.  She says he experienced no adverse effect from the vaccine.  She was instructed to return in 3 weeks for his dose #2 which should be the Adult Pfizer formulation.
No additional AEs; Nurse called to report that an expired ROTATEQ was given to a patient today 4/8/2022.   No additional AEs were reported.   No further information provided.; This spontaneous report was received from nurse and refers to a patient of unknown age or gender.  The patient's medical history, concurrent conditions, or concomitant therapies were not reported.  On 08-APR-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 dose (lot #1707496, expiration date: 29-MAR-2022) administered for prophylaxis (strength, and route of administration were not provided), which had already expired. No adverse event were reported.
Pt recvd vax NOV92 & 24NOV92 lab eval showed an inc GGT, SGPT & SGOT;
She developed shingles 3 days after receiving SHINGRIX. On day 1, three hours after the vaccine administered, she developed fever, body ache, and nausea. 12 hours later, she developed shingles breakout and earache (she has a history of shingles in ears for 6 times), next day she went to see a doctor, who advised to monitor and symptoms are due to immune reaction to SHINGRIX, however, symptoms got worse and on day 4 she was diagnosed with shingles. The doctor prescribed valacyclovir 1 grams 3 times a day for 7 days. Gabapentin 300mg up to 6 capsules per day. Cephalexin 250mg 4 times a day for 7 days.
Report a dry cough  prior to  taking the vaccine, but reports progressively got worst. Treatment: Visit to PCP and placed on Medrol dose pack, Z-Pac and albuterol inhaler. Outcome: Improving with treatment regimen. Does not interfere with ADLs.
Patient received H1N1 at approximately 12:30 pm on 12-15-09.  At 1310 complained of tightness to chest and trouble swallowing. Pt received IM BENADRYL, private MD notified, mother notified, patient transported to hospital via ambulance for evaluation.
I had chills, fever, diarrhea, and vomiting the evening of vaccine.  I felt dizzy and kind of faint. 2 to 3 days later I passed out twice. Wife called ambulance. They checked my vitals and check with my doctor. Next day I went in to see my doctor. My doctors checked my vitals, and I was given IV due to dehydration. I began to feel better after giving IV.
6 inches x 13 inches redness & swelling started day after Tdap given and worsened day 3. Mother gave TYLENOL 1st, then Ibuprofen & BENADRYL, as well as a cool compress on & off. No symptoms by day 6.
Warm, red area just below site of injection that started Friday morning the day after vaccine administration. Site of redness has increased a little in size since Friday and is still warm to the touch.
Patient received Meningococcal B (Bexsero) instead of Meningococcal (Menactra). Patient had no reaction to vaccination while in clinic.
Right upper post lateral arm: red, swollen and warm to touch.  Non-tender.  Redness and swelling well demarked.  12 x 12 cm.  Circumference 22 cm right arm, left arm 18.5.1cm right axillary node not tender.
The patient was vaccinated at 9:30 a.m. Mom left the office, I took him to a car and the patient expressed seeing cloudy vision and fainting on the pavement at 9:50 a.m.
From initial information received on 05/09/03 from a health professional, regarding an adverse event occurring in the US, it was reported that a 14 year old male pt received 0.5 milliliters of his sixth dose of TD ADS ADULT, Lot # U0830AA, in the right deltoid on 05/05/03.  The following day, the pt felt ill with a headache, dizziness and was hot (temperature not taken), along with redness, swelling and soreness at the injection site. Reportedly, the redness and swelling are still present and is the size of 1/2 of an orange. The pt had the nurse at the school assess the site. Reportedly, the pt did not recover from these events. From additional correspondence received on 04/19/03 from the reporter, the pt was seen for a follow up on 05/12/03 at 12:30PM. At that time it was noted that there was no swelling or redness on the left arm. The pt felt well and had no complaint of pain in his arm. Reportedly, the pt recovered from this event. No further information is anticipated, this case is considered closed.
Started with fatigue about 4.5-5 hours after injection then low grade fever. (99 deg) Fever reduced with ibuprofen. About 12 hours after injection fever spiked to 100.7 deg with chills and body aches. Took ibuprofen but didn't reduce fever so an hour later took tylenol and then temp came down. Following day had low grade fever about 99 deg controlled with aspirin as needed and third day low grade fever in the morning only. Symptoms completely gone after that.
direct exposure to COVID 19 and did not get COVID; sore arm; This is a spontaneous report from a contactable consumer. This consumer (Patient's wife) reported for a 50-year-old male patient (husband) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on 21Mar2021 (at age of 50-year-old) as dose 1, single and patient had received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on 13Apr2021 as dose 2, single both for COVID-19 immunization. Medical history included thyroid disorder from an unknown date and unknown if ongoing. Family medical history relevant to AE(s) was none. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for thyroid disorder from an unspecified start date and ongoing. Patient did not have any other vaccination, prior (within 4 weeks) of COVID-19 vaccination. The reporter stated she was just reporting something positively. Both she and her husband had received full vaccination and then had an exposure to COVID and on an did not contract the COVID-19 infection. Mentioned that, the incubation was 10 to 14 days and they were on day 12 taking care of COVID kid. She added as far as awareness, she was unsure what that would be, but as of today she knew that she has not gotten COVID. This was a clone report and created to document the husband's experience. Later on she mentioned her husband got his vaccination before her because they had a cancellation at the pharmacy. She could not remember if she reported anything about her husband before. Added his arm was sore after both doses but it completely cleared up. Confirmed awareness of the sore arm was on the day he got the first shot 21Mar2021. She added they had her son sleeping in a palette in their bedroom; they did not mask but did wash hands really good; and used Lysol in the home. The adverse event did not resulted in any emergency room or physician office visit. Relevant tests were not recently done, he had been tested in the past and it was negative. The outcome of sore arm was recovered on an unspecified date in 2021 while outcome of event direct exposure to COVID 19 and did not get COVID was unknown.  Information on lot/ batch number has been requested.
Information has been received from a nurse concerning a 17 year old female who on 30-MAY-2007 was vaccinated with Gardasil (Lot #657621/0387U). There was no concomitant medication. On 30-MAY-2007 the patient developed impressive swelling and pain in her left shoulder down to her wrist. This occurred after the patient went swimming. It was reported that "the swelling gets less when the arm is not used but comes back when the patient uses the arm". A physician in the office told the patient to elevate and ice the arm in the area for a couple of days, but this did not help. On 04-JUN-2007 a Doppler ultrasound was performed which revealed thrombosis in the arm. It was reported that the swelling and pain were disabling to the patient. The patient's swelling and pain persisted. No further information is available at this time. Additional information has been requested. 6/21/07-records received for DOS 6/11 and 6/17/07- Letter from PCP indicated that DVT is not thought to be due to vaccine it has probably been present for a few weeks. unfortunately it began to grow around the time of HPV thus the apparent association.  Received HPV 5 days ago from this visit of 6/4/07-developed impressive swelling and pain that day while swimming. Arm literally twice normal size with pitting edema into arm pit. Swelling lessesn when not using arm but returns when she tries to swim or exerices. PE:left arm with non pitting swelling over entire arm, skin over arm is warm and well perfused fingers are cool on both hands but well perfused. ROM fine. Treatment, thrombolysis and mechanical thrombectomy, subclavian vein was virtually completely freed of thrombus. An underlying compression of the vein at the thoracic inlet was documented
Injection site rash; Fever; Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE RASH (Injection site rash), PYREXIA (Fever) and HEADACHE (Headache) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 025J20-2A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included VITAMIN D3 for an unknown indication.   On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE RASH (Injection site rash). 25-Jan-2021, the patient experienced PYREXIA (Fever) and HEADACHE (Headache). On 28-Jan-2021, HEADACHE (Headache) had resolved. At the time of the report, VACCINATION SITE RASH (Injection site rash) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, Body temperature: 99.8 (High) Low grade fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was reported to be prescribed a topical cream but she did not fill the prescription.   This case was linked to MOD-2021-002588 (Patient Link).
13 mo brought by mom for over 1 week h/o small "knot" right anterior thigh after vaccinations.  No pain or discomfort.  Small 1" diam. area of non tender induration not 1 right anterior thigh today, afebri asymptomatic.