chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a female patient. It was reported that in January 2007 the patient's pap smear was normal and negative for HPV. In March 2008 the patient's pap smear was normal and no check for HPV. In December 2008, the patient got series of GARDASIL. In 09-May-2009, the pap smear revealed low grade cervical Intraepithelial Ceoplasia (CIN) and positive for HPV. Additional information has been requested.
Pt described dig. SOB 3 days after shot. Exam performed with CBC, chest x-ray, general health panel. Lab pending. Exam normal. I do not believe/support they are related. Pt has had influenza shot in part w/o symptoms or effects.
Headache Body ache  Chills, shivering with cold Back ache mid section on belt line  Restlessness. Unable to sleep Temperature.  100.6  Began 10pm night of injection.  Injection given at 11am  The symptoms are intermittent.   Not all symptoms constantly
Patient felt hot and was sweaty right after vaccination. She felt like she wanted to lay down. When the nurse was trying to bring patient to the cot the patient fainted before reaching the cot. A clerk called 911. The nurse administered 1 dose of epipen at 11:35 am. Patient regained consciousness. She was able to converse with the nurse and was able to drink some water. Her vital signs at 11:39 AM were oxygen saturation of 99 %, heart rate of 42, and blood pressure of 87/60. Patient was brought to the cot to lay down and wait for EMS. EMS arrived blood pressure had increased to 104/68 and heart rate to 50 and patient had some returning of skin color wasn't as pale. Patient did mention she thinks she may have been dehydrated. She was then brought to the ED for further evaluation.
DIZZINESS FOLLOWED BY ITCHY THROAT, COUGH AND DIFFICULTY BREATHING. EPINEPHRINE 0.3MG WAS ADMINISTERED INTRAMUSCULARLY WITH IMPROVMENT BREATHING AND DIPHENHYDRAMINE 25MG WAS GIVEN ORALLY. AFTER 15 MINUTES, EMT'S ARRIVED AND TOOK OVER. HOSPITAL PRESCRIBER DID NOT BELIEVE REACTION WAS ANAPHYLACTIC AFTER SEVERAL HOURS OF MONITORING.
After receiving the vaccine, the next day I experienced headaches, soreness and sliding swelling my arm (could not lift above head), excessive sweating, chills, blirred vision, occasional vomiting, and a low grade fever. I called the triage after experiencing these for 4 days and was told it was a normal reaction. Then on day 5, I began to experience intense stomach pains and vomiting after each meal. I had made an appointment with the first available provider that could see me, as my PCP was booked. She ordered several tests.  I was initially found to have H. Pylori, but that was the first find. Eventually, after almost two months of testing, I was diagnosed with GERD and still have a final blood test needed to finalize or rule out having  Celiac disease. Prior to this, I had not experienced these symptoms, but I changed my diet nonetheless. I also want to note, I had 2 vaccines given post-2nd Moderna dose (both given 6/1/21) - PPSV-23 and Tdap-ADACEL. I had the same symptoms as I did with my Moderna 2nd dose, but the arm soreness was followed by swelling worse than the Moderna vaccine in my arm at the injection site. It was so painful, I could not lift my arm to change my shirt that was drenched in sweat. I scheduled a same-day visit at urgent care when the pain became unbearable (6/3/21). The doctor saw me and he diagnosed me with an allergic reaction and a secondary infection at the injection site. He feared giving me a benadryl shot, as this was my second reaction noted now. Prior to these reactions, I had never had a reaction to a vaccine, and I have kept up-to-date on all vaccines (excluding my tardiness in the last couple of Influenza vaccines). I want to note, I am a huge supporter of vaccinations and tell others to get vaccinated (for not just covid, but all preventable diseases), but I fear what is going on with me now, as I cannot understand why this is happening and wanted to notify your agency. Thank you.
This is a spontaneous report from a non-contactable consumer, who is the patient. A female patient of an unspecified age, race, and ethnicity received the second dose of PREVNAR 13 and FLU vaccine; both via an unspecified routes of administration on 24Oct2016 at single doses for immunisation. The patient's medical history and concomitant medications not reported. The patient previously received the first dose of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) on an unknown date in 2015 for immunization. On 24Oct2016, it was realized the patient experienced inappropriate dose of vaccine administered. This was further elaborated as the patient received two doses of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein); one in 2015 and another on 24Oct2016. On 24Oct2016, the patient also experienced soreness in the arm. The clinical outcome of the events, inappropriate dose of vaccine administered and soreness in the arm, was unknown. No follow-up attempts are possible. No further information is expected.
3 cm x 5 cm induration, redness, & numbness right arm MMR vaccine. Pt. complaining itchiness left arm VARIVAX vaccines.
(1) Swelling & redness, warmth, pain for area covering (R) deltoid & biceps down to elbow. Began within 24 hrs, had decreased by 4 days. (2) Parents report very active behavior, strange thoughts.
This case was reported by a pharmacist and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On 4, 7 or 8 November 2011 the subject received a dose of FLULAVAL (.5 unknown route, unknown). On an unknown date in November 2011, several hours after vaccination with FLULAVAL, the subject experienced injection site redness, swelling injection site and injection site pruritus. According to the pharmacist, the hospital had a flu clinic between 04 November through 08 November 2011. Approximately 40 subjects were administered FLULAVAL from the same lot. Of the 40 subjects, five subjects experienced injection site redness, swelling and pruritus. This case was associated with a pharmaceutical product complaint. The pharmacist was suspecting a questionable batch of vaccine. She noted that a sister site had administered FLULAVAL with a different lot number and had no adverse events reported. At the time of reporting the outcome of the events was unspecified. This is one of five cases. See cases A0952520A, A0952521A, A0952522A and A0952523A for information regarding the other cases.
Felt quesy about 15 minutes after shot. 45 minutes after shot got really tired, eyes started hurting/getting irritated, itchy throat. 1hr - 2 hrs after shot sever stomach cramping, and chills Next morning - still had slight chills, left arm sore, and still extremely tired.
Injection site pain Tiredness  Headache Muscle pain Chills Joint pain  Fever Feeling unwell
Hives tattoos welting itching in throat 25 mins headache congestion wheezing muscle aches whole body tingling 16 hours vertigo dizziness cloudy thoughts 24 hours
The pt cried from 15 min after until 10:00 PM that night. No temp was reported. Baby is ok as of 1/31/01.
WHEN TAKEN DEEP BREATH LEFT  PAIN INSIDE OF THE LEFT BREAST (CENTER OF CHEST); CHEST PAIN, SORENESS OF CHEST; LOWER BACK PAIN; SORE ARM; MILD HEADACHE; FATIGUE; MILD ABDOMINAL DISCOMFORMT (SIDE STITCH) ON LEFT SIDE TO  RIGHT; This spontaneous report received from a patient concerned a 45 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, Laboratory data included: Blood test (NR: not provided) platelets were normal. On APR-2021, treatment medications included: naproxen sodium. On 09-APR-2021, the subject experienced sore arm. On 09-APR-2021, the subject experienced mild headache. On 09-APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced lower back pain. On 17-APR-2021, the subject experienced chest pain, soreness of chest. On 17-APR-2021, the subject experienced when taken deep breath left pain inside of the left breast (center of chest). On APR-2021, the subject experienced mild abdominal discomformt (side stitch) on left side to right. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lower back pain on 10-APR-2021, when taken deep breath left pain inside of the left breast (center of chest) on 17-APR-2021, and sore arm, and mild headache on APR-2021, and had not recovered from chest pain, soreness of chest, fatigue, and mild abdominal discomformt (side stitch) on left side to right. This report was non-serious.
Seen 6/15 in office with 2wks of nasal sx and 3 days eye sx. Started on abx. on 6/17 developed fever 102, rash and fussiness. Fever resolved after 24hr. rash spreading, still fussy.
Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL (lot # not reported). On an unspecified date, the patient experienced genital warts. The patient sought unspecified medical attention. At this time of reporting, the patient's outcome was unknown. This is the first of two reports from same source. Additional information has been requested.
This case was reported by a other health professional and described the occurrence of drug dose interval too long in a female patient who received CERVARIX. On an unknown date, the patient received CERVARIX at an unknown dose. On an unknown date, an unknown time after receiving CERVARIX, the patient experienced drug dose interval too long. On an unknown date, the outcome of the drug dose interval too long was unknown. It was unknown if the reporter considered the drug dose interval too long to be related to CERVARIX. Additional information: A patient was vaccinated with only 2 doses of CERVARIX. Recommended schedule was 3 dose (0, 1 and 6 months).
Patient reported he was experiencing mild nausea and arm pain shortly after receiving #1 Shingrix injection in the morning. He reports he started to feel progressively worse by 9PM and had increasing nausea and began sweating. He stood up from his couch to go to the bathroom and blacked out. He does not remember making it to the bathroom but woke up on the floor of his bathroom drenched in sweat and had lost control of his bladder. He believes he was passed out for 5-10 minutes. He went to sleep and woke up with mild nausea. He does not have a history of seizures or similar episodes like this in the past and was feeling well before receiving the Shingrix vaccine.
expired dose of engerix-b; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 70-year-old female patient who received HBV (Engerix B) (batch number 9p9b5, expiry date 4th February 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th May 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 27th May 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 3-June-2022 Reporter's comment: The pharmacist reported that a patient received an expired dose of engerix-b. The reporter consented to follow up. Additional Supportive Information: The patient received an expired dose of engerix-b which led to expired vaccine used.
VACCINE WAS ADMINISTERED AFTER THE 30 DAY PERIOD THAT VACCINE IS ALLOWED TO BE STORED IN THE REFRIGERATOR.  PATIENT DOES NOT REPORT EXPERIENCING ANY ADVERSE EFFECT TO THE VACCINATION.
Associate was given flu vaccine 11/4/21 by vaccinator (I did not give this vaccine). Per employee," I received the flu shot to my right arm. On the night of receiving the shot I noticed the injection site to be red and warm. The area is swollen. The areas is the size 3inx 2in around. No pain noted, full range of motion. induration was circled around site last night and has gone down some since.
Received second dose in series after 4 months from first dose. With first dose experienced issues with feeling of numbness in knees, shins, and feeling of intermittent pin prick feeling throughout body and feet pain. No weakness. These adverse issues slowly resolved.  Was required by employer to get second dose or face termination of my job and security.  ALL symptoms again came back after second dose and with numbness extending to sides of calfs along with knees and shins.  Pin prick feeling reoccurred.  No weakness.   After four months now after second dose symptoms are less intense but have not resolved. No finding with primary care ordered test. Will follow up with neurology consult.
Two days after inhalation of FluMist, perioral rash and nasal itching reported.  Treated with Benedryl and resolved.
This spontaneous report was received from a physician refers to currently 6 months old child as a female patient. No pertinent medical history was reported. Patient had no allergic reactions. On an unknown date, the patient was vaccinated with oral, ROTATEQ (dose and lot# were not reported). Concomitant therapies included PEDVAXHIB and PREVNAR. On an unknown date, within 24 hours the child had developed hives all over the body. Patient sought medical attention, contacted physician. The patient was given treatment with Antihistamines (unspecified name). On an unknown date, the same vaccines were administered again and within 24 hours on an unknown date approximately in July 2015 (also reported within the past month) the child developed hives all over the body. This had now occurred twice for the child. The patient was given treatment with Antihistamines (unspecified name). Physician stated he will perform skin test on the child. No Product Quality Complaint (PQC) was involved. Action taken was unknown. The outcome of event was unknown. The reporter did not provide the causality between the event and the suspect therapy. Additional information has been requested.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 17-JAN-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot # M025871, expiration date: 24-MAY-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all required data has been obtained.; Sender's Comments:  US-009507513-1611USA004113:
Patient started getting achy, running temperature of 100 degrees, arm soreness at injection site, vomiting and diarrhea 1 time in early am, diarrhea again 1 time in late morning.  Skin "hurts".  Taking Ibuprofen as needed.
This case was reported by a consumer via sales rep and described the occurrence of injection site pain in a 53-year-old male patient who received SHINGRIX (batch number XC534, expiry date 4th July 2020). On 5th February 2018, the patient received the 1st dose of SHINGRIX. On 5th February 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. In February 2018, the outcome of the injection site pain was recovered/resolved. The reporter considered the injection site pain to be probably related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but could be 53 or 52 years old. Pain at the injection site lasted for 3 days. On 21st April 2018, the patient received 2nd dose of SHINGRIX in the left deltoid (batch number XC534, expiry date 4th July 2020).
fever; chills; headache; extreme bodyaches; This is a spontaneous report from a contactable nurse reporting for herself. A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 19Jan2021 at 12:30 PM (at the age of 64 years old) as a single dose for COVID-19 IMMUNIZATION. Relevant medical history included anemia, hemachromatosis, and penicillin allergy. The patient previously received the first dose of BNT162B2 on 29Dec2020 at 12:15 PM (at the age of 64 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Concomitant medication included epoetin alfa (PROCRIT) and deferasirox (JADENU). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Jan2021 at 08:00 PM, the patient experienced fever, chills, headache, and extreme bodyaches. The patient did not receive any treatment for these events. The outcome of the events fever, chills, headache, and extreme bodyaches was recovering. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Father states noticed firm red left lateral thigh yesterday morning after waking up.  Child also had temp of 100 degrees.  Dad states child did not complain of pain, but was acting more tired than usual.  Mom called office around 4pm on 9/2/10; gave Motrin and applied ice with some relief.  Seen today with 5 1/2 cm by 4cm area redness to left thigh.  Child has full range of motion, denies pain, and is actively playing without signs of distress.
Initial report received from a health care professional on 08 October 2007. A 19-year-old female received a first left tricep subcutaneous injection of YF-VAX (lot number UF191AA) and a first dose of Twinrix (lot number AHABB100AA; route and site of administration not reported) on 08 October 2007. The patient's parent contacted the vaccine provider 45-60 minutes post vaccination, reporting that the patient was short of breath. The patient was advised to go to the Urgent Care Center. The patient's arterial blood oxygen saturation was 91% pre-treatment. The patient received treatment with Benadryl, epinephrine and a hand-held nebulizer. The shortness of breath resolved and outcome was reported as 'recovered'.
hand was so swollen it looked that it was going to burst; chills; headache; body aches; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (hand was so swollen it looked that it was going to burst), CHILLS (chills), HEADACHE (headache) and MYALGIA (body aches) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (hand was so swollen it looked that it was going to burst), CHILLS (chills), HEADACHE (headache) and MYALGIA (body aches). At the time of the report, SWELLING (hand was so swollen it looked that it was going to burst), CHILLS (chills), HEADACHE (headache) and MYALGIA (body aches) outcome was unknown.
It started the day I got the injection. There was a dull ache and pain at the site. I was told that was normal. It continued and at day 4, I started getting aches and pains in my neck, both knees, feet and hands. There was noticeable swelling in these joints. As the days progressed, the aches and pain radiated to my elbows. I finally made an appointment to see my doctor. I went in on July 25, 2018 and described what I was going through. The CNP did some blood work and told me to try TYLENOL Extra Strength and ASPERCREAM with Lidocaine. I tried both, but neither worked. The blood work came back, showed inflammation. I asked about the vaccine, since the time frame seemed to correlate to all my symptoms. The nurse called me back and spoke to my doctor as well as an internal medicine doctor on staff, and both agreed that it could be an adverse reaction to the vaccine. The internal medicine doctor said he had a patient with similar symptoms caused by the vaccine and the symptoms lasted about 6 weeks. I was advised NOT to get the 2nd part of the vaccine. I am now week 7 and there hasn't been any significant change. Last week, the swelling, aches and pains were so severe that I couldn't get out of bed, out of a chair or get dressed or do any activities of daily living without the assistance from my husband. The pain may subside a little for a little while and then come back again, but the ache and swelling is constant. I have also tried ice packs, soaking the extremities in cold water. It gives me temporary relief. I have been taking ibuprofen 400 mg in the morning and at night and that seems to help a little, but the swelling still remains in the joints. I have not experienced any fever, headache or the like. Prior to this vaccine, I had no problems with my joints. I have a follow up visit with my primary care doctor September 24th. If the symptoms don't get any better before that, I will have to try to get to see another doctor or go to the ER. I should mention that I thought the pharmacy assistant who gave me the injection gave it up too high on my arm. It was almost to the shoulder. He gave my husband the injection as well, in the same area of his arm, but my husband only had flu like symptoms for a few days. I would also like to mention that I received the original Shingles vaccine (ZOSTAVAX) on November 27, 2014 when I turned 60. I did not have any reaction to that vaccine. I also forgot to mention that there were 2 days where the injection site hurt so badly that I couldn't lift my arm at all.
Patient received Covid-19 vaccine (first dose) at our store today at 9:40 am. Patient was advised to stay in the area for 15 minutes for observation. Patient was sitting in the waiting area. At around 10:00 am, patient's mom knock on the door saying that her son might have an adverse effect. Patient stated he was feeling dizzy and was about to lose consciousness. He also stated he lost his vision. Patient was alert and was able to answer questions. Medics arrived and took his blood pressure. He was transported to the hospital
Rash appeared Sunday: Monday AM , Mom took child to ER to have confirmed. Doctor not in. Benadryl given with instructions on skin care. Appontment MD 9/24, 9/27, 9/28
2 cycles of illness. Day 1 and 4: fever, loss of appetite, sinus/cough. Day 2 and 5: same & apathy, unresponsive mental state & intestinal rumbling. Day 3 and 6: improved state: sinus/cough & light appetite.
This spontaneous report as received from a healthcare worker refers to an unspecified patients of unknown age and unknown gender. Since on an unknown date in March 2015, the unspecified patients were vaccinated with improperly stored doses of GADASIL (lot # J011272 and expiry date: 21-APR-2016) (dose and frequency were not reported). No adverse effects were reported. No product quality complaint was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
Fever, Myalgias, Cervical and Upper thoracic neck and back pain, pain radiating down right arm
Pfizer Covid Vaccine Bivalent 5-11yr was mistakenly mixed with too little diluent. Medical Assistant only used .13ml diluent instead of 1.3ml diluent to mix the vaccine, so vaccine administered was concentrated too strong. Dose drawn up and administered was .2ml. Parent notified and watched child for any additional symptoms post vaccine, but did not report any between 12-6-22 and 12-9-22.