chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pharmacy told the caller that the ZOSTAVAX vaccine she received "was not effective." and she would need another shingles vaccine.; This spontaneous report was received from a currently 58-year-old female patient referring to herself.  The patient's concurrent conditions included eczema. The patient's medical history included chickenpox as child. The patient's concomitant therapies included low dose of unspecified blood pressure medicine and risankizumab (SKYRIZI) (reported as "Shyrizi").  On 16-JUL-2014, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) for the prevention of shingles. After eight years the caller was told "by a friend that vaccine live(ZOSTAVAX) was not effective." According to the patient, she decided to do some research and found information on internet suggesting that her vaccine live(ZOSTAVAX) vaccine was "no good," The caller stated, she received vaccine live(ZOSTAVAX) at her local pharmacy, so she contacted them  18-JUL-2022 to ask about the efficacy of the vaccine; the pharmacy told the caller that the vaccine live(ZOSTAVAX) vaccine she received "was not effective" and she would need another shingles vaccine. The caller was unable to provide any additional information pertaining to the vaccine live(ZOSTAVAX) vaccine she received, however, she was going to call her local pharmacy back to retrieve that information. She would like to get more information about a reimbursement. No further information was provided. No additional adverse event was reported. No product quality complaint was reported.  The outcome of drug ineffective was reported as not recovered.  The causal relationship between the event and the suspect therapy was not reported.
10cm oval of erythema, rock hard induration covered with firm tiny vesicles around 1mm in size with several (1/2 cm vesicles): did not break down with pressure.
She is adamant that the Prevnar13 vaccine was blood red. She was tangential in her speech but here is a list of what her concerns/accusations are: Vaccine was blood red Made her very ill Pooping on walls Made her pee her pants (pee was dark brown) Attacked her spinal cord Coworkers who used her mobile phone and keyboard at work contracted something from her that she says is from the vaccine One committed suicide 4-21-21 as a result of illness they got from her that she believes was from the vaccine Coworker was taken from work in ambulance with back pain due something he contracted from her from the vaccine She believes the vaccine was tampered with and asked who had access to the fridge in pharmacy When she returned to work, she felt it was odd people were talking with her about feline HIV as a form of mental manipulation She said this was related to the vaccine and another reason she thinks it was tampered with Her neighbors are terrorizing her Hacking her phone Using stole bucket truck to hack her internet and electricity Broke into her locked house, hurt her dog and stole her covid card "bought" her doctor so she could not get good health care
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypertension-Medium, Systemic: Nausea-Medium, Additional Details: patient reported dizziness, chills, nausea post vaccination. had patient lie down for 30 minutes, monitored blood pressure: readings 140/90, 168/110 and 170/111 every 10 minutes. we were going to call 911 due to elevated blood pressure but patient refused and stated she felt a lot better and wanted to go home and rest.
Initial information received from a healthcare professional who is the patient on 16 August 2013. On 6 August 2013, a 42 year old female patient was administered ADACEL, batch U4655AA into the right deltoid (route not reported). The patient's medical history was reported as severe gluten allergy, celiac of the skin, dermatitis herpetiformis, grass, sulfa, quinolones and shellfish allergies. The patient was immunized with Tetanus only vaccine in the past on an unreported date. Concomitant medications and laboratory tests were not reported. On Friday 09 August 2013, the patient experienced a rash which started on her neck and spread to her chest, back, legs. It was raised, itchy with no drainage. No fever was noted and the rash was not hot to the touch. The patient took BENADRYL, route and dose not reported and unspecified topical hydrocortisone. The patient continues to experience the rash, but it is improving now. The patient is an RN and did not seek medical advice. The patient outcome was reported as not recovered. Documents held by sender: None.
While Administering Adacel injection the needle was loose and approx 1/2 the vaccine was injected. Discuss with MD about this. We will administer Adacel at next visit at no charge.
The following day after the vaccination a rash appeared on the torso and both legs.  They were red blotches that were not raised. It looked like chickenpox. The rash was visible for 5 days and felt like a sunburn but not itchy.  I ran a fever of 102.1 for 2 days. 3 days after the vaccination I began to have a migraine and felt like my head was swelling. I started having vertigo that evening and was unable to stand for more than 5 minutes. Went to PCP on that Monday and was given  Ondansetron 8 Mg Disintegrating Tablet and  Meclizine 25 Mg Tablet. Believed that I was having a flare from Meniere's disease. The symptoms from the flare have stopped as of 03/02/2021.
pt recv vax 12JAN96 & 21APR97 pt exp over 100 lesions on head, face & trunk & pruritus;pt recovered from exp;
Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Severe, Additional Details: Patient complained on leg/muscle pain in leg starting day after vaccine was given. Symptoms are improving. Patient also complained on severe lethargy/exhaustion last for 2 weeks post administration
Information has been received from a physician concerning a 61 year old patient who on 25-JUL-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  On 27-JUL-2007 the patient developed shingles.  Medical attention was sought and VALTREX was prescribed for the symptoms.  No further information was provided.  There was no product quality complaint involved.  Additional information is not expected.
patient administered an expired Flublok vaccine with no reported adverse event; Initial information received on 22-Mar-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves patient (unknown demographics) who was vaccinated with an expired dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (expired product administered).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  It was also reported that they administered an expired Flublok vaccine and want to know what to do. He wanted to know if we had any treatment recommendations for the patient because he said he knows the patient will ask. This is all the information he provided at the time of his call. Reporter relationship: HCP (health care professional)  At the time of report, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Joint/muscle pain (whole body), headache, nausea, shivering - all interfering with sleep, causing frequent waking.  Symptoms resolved by mid morning of following day.
This spontaneous report as received from a Registered Nurse, the nurse reported than an unknown number of patients were vaccinated over a period of 1 year with tetanus and diphtheria toxoids, adsorbed(manufacturer unknown), GARDASIL, RECOMBIVAX HB and PNEUMOVAX23 stored as low as 25F during that year long period of time. No adverse effect reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Information has been received from a health professional concerning a 13 year old female who in the Fall of 2007 was vaccinated with the first dose of GARDASIL. Per the reporter when she went home she "broke out in rash that lasted about a week or so." Subsequently, the patient recovered from the rash. No further information was provided. Additional information has been requested.
Patient asked for her 3rd vaccine (Booster). It has only been 3 months since her 2nd shot. The date on the 2nd dose was not noticed until after her booster was given. Patient had no trouble with the vaccine while she was being observed during her 15 minutes of observation after receiving the vaccine. HEr initial doses were Pfizer.
Severe site reaction. Redness, welt, rash, itchy, and painful. The welt is the size of a softball, the res portion is the size of a baseball.
Awoke to my son making gasping noise, elevated temperture 105, and in the process of a febrile seizure.  Notified 911 who dispatched an ambulance, removed exterior clothing to reduce core body temperature.  EMS transported him to hospital giving him diazepam en route.  Total seizure time from time of discovery until symptoms terminated was 23 minutes.  CT scan of head/chest showed nothing abnormal.  Patient was given oral amoxicillin.
3 days after vaccine developed painful erythema that continues X 5 dats.  Possible cellulitis
Swelling, redness distal to the injection site. Pt concerened will go to clinic to follow up.
About 20-30 min later she felt dizzy, She went to Volleyball practice and felt ok. When she got home she felt nauseous. The Left arm became swollen and hot over noc.
This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date the patient was vaccinated with expired PNEUMOVAX 23 lot # N000463 for prophylaxis. The physician also stated that PNEUMOVAX 23 did not have prior excursions prior to vaccination.
Hives of right wrist after second dose; This is a spontaneous report from a contactable consumer, the patient. A 18-year-old non-pregnant female patient received a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in left arm on 28Apr2021 at 11:00 (at the age of 18-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not receive any concomitant medications. The patient had no known allergies. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in right arm on 05Apr2021 at 17:30 (at the age of 18-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 30Apr2021 at 09:00, the patient experienced hives of right wrist after second dose. Therapeutic measures were not taken as a result of the adverse event. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. The patient had underwent COVID-19 Ag CARD test (nasal swab) on 23Apr2021 and the result was negative. The clinical outcome of the event hives of right wrist was recovering at the time of this report.  No follow-up attempts are needed. Information about lot number cannot be obtained.
Symptoms occurred at site L deltoid plus or minus 1/2 hour after administration of Flu vaccine. She returned to the nurse who administered injection then went to the ER where she received Benadryl by mouth and Pepsid. Symptoms include: felt faint, dizzy, with itching at injection site, also had tingling lips & flushing.
This female subject was enrolled in the prophylactic double blind study. On 28 October 2004, 2 December 2004 and 25 April 2005, the subject received the 1st, 2nd and 3rd dose of HPV IM deltoid or Havrix 720 EU, IM deltoid. This subject received Havrix (lot DVHA817B9). The subject's past medical history included no previous pregnancy. The subject and her partner had no abnormal medical and family history. The subject used no contraception method. Her last menstrual period occurred in June 2006. The subject was exposed to the vaccine before conception. The estimated delivery date was in March 2007. On 09 Sept 2006, 17 months after the 3rd dose of blinded vaccine, this 18 year old subject developed an abortion spontaneous complete. No dilation and curettage was needed. Outcome was unknown at time of reporting. Investigator causality was unknown at the time of reporting.
Information has been received from a physician concerning an 18 year old female who on an unspecified date was vaccinated with a third dose of Gardasil.  Subsequently, the patient developed chronic abdominal pain, vaginitis and body aches.  Outcome was not specified.  Additional information has been requested.
about 1/2 hr p/inject non-stop crying for 6 to 7 hrs; the next day was lethargic for 3-4 hrs;
NO adverse effect reported; patient was administered a dose of PROQUAD that was less than the full recommended; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 03-SEP-2019, the patient was vaccinated with  a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (dose, frequency, route and vaccination site were not reported) lot # S006828, expiration date 02-SEP-2020, for prophylaxis that was less than the full recommended dose. Medical assistant reports that after administration a "few drops" of the vaccine "dripped from the insertion site". No adverse effect reported.
Sore left arm, muscle pain, joint pain, headache, fatigue for about 18 hours. Symptom severity 7 of 10.
Bright red rash on both legs beginning mid-calf, continuing down to feet.  Mild irritation; looks worse than it feels.
ten minutes after injection - metal/bloody taste in mouth, pain in both arms and hands, then numbness starting in hands, heart palpitations, increased heartrate, tightness of chest, tightness of throat, uncontrolled full body shaking, full body numbness with injection location exacerbated (with no feeling upon injection), blotchy skin, dizziness, headache, eye ache, muscle tension throughout, pressure in head and chest, muscle weakness, chills, hot flashes,  lasted for about an hour and a half for most - then tightness of the chest, dizziness, headache, eye ache, pressure throughout continued for days
- Body aches (8/10). - Fever, chills. - Injection site redness, inflammation. - Loss of appetite. - Pt seems better today, 9-24-12.
SEVER HEADACHE W/ MUSCLE PAINS RUNNING UP AND DOWN ARM INTO HAND, INTO MIDDLE BACK AND ACROSS SHOULDER BLADES INTO NECK. SWELLING IN ARM WHERE SHOT WAS INJECTED.THIS LAST FOR CLOSE TO 2 WEEKS. LOSS OF USE OF ARM FOR MORE THAN THREE DAYS. SEVER WEAKNESS, WITH ALMOST FLU-LIKE SYSTOMS. CALLED BOTH CHILDREN'S  MERCY AND HIS PCP AND ASKED FOR HELP, NOT MUCH WAS GIVEN EXCEPT NOT TO GIVE HIM ANOTHER SHOT AGAIN OF THIS (Td). ASKED THAT A REPORT BE FILED TO CDC.
Left Arm Rash  3 inches x5 Inches started 1-21-21   continues to fade, but still very red and visible on today 1-28-2021 No pain, no itch, but warm to touch
Information has been received from a consumer concerning her son who on an unspecified date was vaccinated with a dose of GARDASIL (dose, route, and lot# not reported). On an unspecified date the patient experienced a seizure 83 days after the shot was administered. Patient was now taking anti-seizure medication (name and manufacturer unspecified). The patient's outcome was not reported. Upon internal review, seizure was determined to be an other important medical event. This is one of several reports received from the same source. Additional information has been requested.
This is a spontaneous report from a contactable nurse through a company representative. This nurse reported similar events for two patients. This is the second of two reports. A patient of unspecified age, gender and ethnicity received PREVNAR 13 on unknown date at single dose. Exact dates of vaccination are not known, but the reporter states it was over a three year period. Patient medical history and concomitant medication were not reported. On unknown date the patient had chronic respiratory symptoms. The patient was referred to an allergist and immunologist, who told that pneumococcal protection was low and required follow up with PNEUMOVAX 23. After that this pneumococcal vaccine was given the patient had less chronic respiratory symptoms. Outcome of events was reported as unknown. Follow-up (16Mar2015): Follow-up attempts completed. No further information expected.
After receiving the FLUVIRIN (MDV) vaccine, the patient's arm display erythema, red/raised circle around injection site approximately 2 inches in diameter and warm to the touch. Patient does not report pain or discomfort.
Per client noticed redness and itchiness on right arm where she received vaccine 1 day after. Per client is resolved on its own, did not take medication for this. Client also reported throat itchiness on day 2. Client denied shortness of breath. Per client took ibuprofen and symptom resolved by day 3. Client stated not following up with provider as it resolved on its own. Medical history of seasonal allergies and takes over the counter medication for allergies and fiber for digestion.
Slight sore throat Friday and Saturday then went away. Neck pain started Saturday evening around 4 and continues until to day 02/07/2000.
Dizziness/Lightheadness also heart beating hard in chest and went to Dr  & EKG ABNORMAL. Referred me to Cardiologist.
Modern a dose 1: very painful at injection site and could not raise arm above shoulder for 48 hrs. Modern a dose 2: flu symptoms 4 days.  Followed by cold sore outbreaks on 3/10,3/28,4/10,4/23 and 5/23. Prior outbreaks 1-2 times a year.  Frequency of cold sore outbreaks GREATLY increased.
I had some tingling and then numbness in my face (right) and right arm and it lasted 2-3 hours. I had the same symptoms 4 weeks after the vaccine. I did not take the second dose of the pfizer vaccine on recommendation from the doctor since we do not know if these symptoms are related to the brain.
pt recv vax & devel a bulging fontanel, profuse vomiting, & lethargy;fontanel was still bulging sl @ the date of this report;this is a serious labelled event;d/t atypical circumstances of the event, it is being submitted in a 15-day t
Patient received a Prevnar 20 immunization on 04/28/22.  Came to the pharmacy today with adverse reactions of redness, swelling, and hot to the touch. the arm was swollen around the injection site and warm. The redness did streak down to the elbow.  The patient also reported there was some fever the first couple days and some swelling in the armpit that had gotten better.  The patient had used some ice and some pain medicine, but came to see if normal. No reports of shortness of breath or difficulty breathing. I called the drug company who reported that redness could last up to 10 days and if it did not get better to seek medical care for follow up.  I informed the patient to continue to use ibuprofen and ice and we would check back in a few days to see if any improvement. I told her I believed it to be a local reaction, but more pronounced than most people experience
The day after receiving the vaccine patient says he began devoloping soreness and tenderness in most of the left arm as well as left thoracic side of body that has lasted about a week. No fever. Ibuprofen controls the pain. Recommended follow-up to be cautious or in case it is something else; patient is going to watch it for a day or two more to see if there is imrovement first.
Information has been received from a physician concerning a 26 year old female with hypothyroidism and a history of papanicolaou smear abnormal and no history of drug reactions/allergies who on 06-NOV-2006 was vaccinated with first dose of Gardasil (yeast) 0.5 ml IM. On 18-JAN-2007, the patient was vaccinated with a second dose of Gardasil (yeast) (lot # not reported). Concomitant therapy included SYNTHROID and LO/OVRAL. On 18-JAN-2007, fourty-five minutes after receiving the second dose, the patient experienced generalized itching. No additional symptoms were noticed. Medical attention was sought. The physician prescribed BENADRYL and the symptoms resolved. The patient fully recovered on 18-JAN-2007. No further information was available at the time of reporting. Additional information has been requested. This is in follow-upinformation has been received from a physician and a nurse concerning a 26 year old female with hypothyroidism and a history of papanicolaou smear abnormal and no history of drug reactions/allergies who on 06-NOV-2006 was vaccinated with first dose of GARDASIL 0.5 ml IM.  On 18-JAN-2007, the patient was vaccinated with a second dose of GARDASIL (lot # not reported).  Concomitant therapy included SYNTHROID and LO/OVRAL.  On 18-JAN-2007, forty-five minutes after receiving the second dose, the patient experienced generalized itching.  No additional symptoms were noticed.  Medical attention was sought.  The physician prescribed BENADRYL and the symptoms resolved.  The patient fully recovered on 18-JAN-2007.  No further information was available at the time of reporting.  In follow-up it was reported, the patient had no reaction after the first dose of GARDASIL.  After the 2nd dose, the patient left the office and later experienced a slight resolved.  The patient had no other allergic symptoms.  Additional information has been requested.
ITCHING ON NECK, BACK, LEGS.  HIVES PRESENT ON NECK.
Drug rash-maculopapular rash. (similar to Ampicillin rash)
DOWN FOR A FEW DAYS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced down for a few days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of down for a few days was not reported. This report was non-serious. This case, from the same reporter is linked to 20210731626.
Sharp pain w/cramping in left hand, mostly from wrist to knuckles. Pain has gone up to elbow & lasted 15 sec & happens throughout the day. Pain has gotten progressively worse in the past 3 days.