chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Delayed reaction to the vaccine that began 6 days after first dose and persisted for approximately 3 days. I first became itchy on my abdomen and arms, I then developed flat oval hives and my eyes and upper lip began swelling. My throat did not swell. I took 2 Benadryl that evening that helped the itch and caused the facial swelling to subside somewhat. I slept thru the night and when the Benadryl wore off in the morning, the same symptoms returned. I took 1 Benadryl which again calmed the symptoms. The same symptoms returned in the evening and I went to an Urgent Care. I was prescribed Prednisone and more Benadryl. These medicines helped to calm the symptoms even more, but the itchiness and hives did come and go thru the next day. On day 3 I took Zyrtec in addition to my last dose of Predisone and the itchiness subsided completely. I took one more dose of Zyrtec the next day and the symptoms have not returned. I followed up with my PCM who tested for a Hazelnut allergy as I had eaten them that first night. She also referred me to an Allergist. I saw the Allergist who said in their opinion my immune system was having a reaction to the first dose of the COVID-19 vaccine and classified me as "medium risk" for the second dose. He recommended that I still get the second dose and to premeditate with Zyrtec the night before, day of and for 7 days following.
Medical Assistant did not double check if right vaccines were pulled. Vaccines that were pulled, Pediarix, HIB, PCV13, and Flu. Vaccines were verified by provider. Vaccine error was not caught until after patient was left. Mom was called and informed about event and was told that Medical Assistant will follow up today and tomorrow morning as well. Mom acknowledged information.
I had  severe irregular heartbeats; Anxiety; Headache; Feeling of severe unwellness; Dizzy; Fatigue; Felt like was spaced out; Had a taste of metal or something in my mouth; Sore arm; This is a spontaneous report from a non-contactable consumer (patient). A 56-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8737), dose 1 via an unspecified route of administration, administered in Left Arm on 02Apr2021 (at 03:30 PM) single dose for covid-19 immunization (at the age of 56-years-old). Medical history included Mitral valve prolapse, anxiety. The patient's concomitant medications were not reported. The patient previously took Aspartame, MSG, caffeine, Augmentin, Biaxin. artificial ingredients and experienced drug hypersensitivity. Patient was not diagnosed with COVID-19 prior to the COVID vaccine and since the vaccination the patient has not been tested for COVID-19. Patient did not receive other vaccine within 4 weeks prior to the COVID vaccine. Patient had to stay in bed. She went to (withheld) 6 days after the vaccine. She received a echocardiogram that revealed patient have a mitral valve prolapse. Patient was slowing feeling better a month later. On 02Apr2021 (at 03:30 PM), the patient experienced severe irregular heartbeats, anxiety ring, headache, feeling of severe unwellness, dizzy, felt like was spaced out, had a taste of metal or something in my mouth, sore arm.  She experienced this 5 hours after receiving the vaccine and lasted over a month. The outcome of all the events was recovering.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 31-MAY-2016 the patient was vaccinated with a dose of M-M-R II (therapy type rHA, lot # L043702, expiration date 03-NOV-2017, dose and route not reported). The vaccine was improperly stored under 50.1 Fahrenheit degree for 1 hour 43 minutes. No previous temperature excursion. Data logger was involved. No adverse event reported. This is one of two reports received from the same reporter. Additional information has been requested.
2:15pm Pt stated she felt dizzy and nauseated. Pt was alert and oriented. Warm and dry to touch. B/P @ 128/75 p-89  Code assist Team called and was taken to Adult walk in Clinic.
mom states beginning 14JUL92 PM pt had t103 R; APAP given w/mild relief of temp but elevated again w/in 4 hrs to 103; temp stable by  day #2 PM; MD advised to withold Pertussis;
Uncontrollable shivering, sweating, dizziness upon standing 10:30pm - 4:30am. 24 hours after injection - exhaustion, headache, body ache, left arm and left breast itching; Day 3 - still tired, arm itches a little, but much better. NOTE: I reacted the same way but worse and longer with my second dose of Moderna.
fatigue, muscle aches, and sinus pain beginning approximately 16 hours after shot and ending within 24 hours after initial symptoms
The pt experienced a localized redness, swelling to the entire upper left arm. the pt complained of nausea and body aches.
Hi dose flu vaccine given approx 1 1/4 inches below acromion process. Felt immediately that shot not in deltoid. Felt bursting like sensation and nausea. Minor pain that day increasing steadily within next several days. E-mail to provider on 9/25 re shoulder pain from shot. Told to come in for return visit. Return visit 10/7. Told to ice and Ibuprofen and TOPRICIN cream. 10/17 notified office that pain still not resolving. Referral made to orthopedics. Seen by Sports Medicine. X-ray and examination. Dx of synovitis and tenosynovitis L shoulder. Steroid shot given into joint. Continue with pain.
FLU LIKE SYMPTOMS; 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 flu like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of flu like symptoms was not reported. This report was non-serious.
looks like burn blotches under his right vaccinated arm, below elbow. he rubbed one and the skin fell off.
No adverse effects; patient was vaccinated with improperly stored MMR II; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.   On 04-MAR-2019, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot # R008031 and expiration date 18-MAR-2020 for prophylaxis (dosage schedule, route, and anatomical location were not reported). Other suspect therapy was sterile diluent for prophylaxis (dosage schedule, route, anatomical location, lot number and expiration date were not reported). The administered dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) experienced a temperature excursion above 9 degrees Celsius (8.59 C) for 15 minutes, and for sterile diluent experienced a temperature excursion above 1.18 degrees Celsius for 33 hours, as recorded by a data logger. There was no previous temperature excursion. No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA001733:
Treatment for COVID-19; Treatment for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Oct2022 at 15:45 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 82 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 01Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 04Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CLONIDINE; SERTRALINE; METFORMIN; PANTOPRAZOLE; BISOPROLOL; AMLODIPINE; HCTZ; ALLOPURINOL; ATORVASTATIN; LEVOTHYROXINE; LORAZEPAM; D3. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Oct2022, outcome "not recovered" and all described as "Treatment for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Oct2022) Positive; (22Oct2022) Positive,  (22Oct2022) Positive; (22Oct2022) Positive; (31Oct2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19: Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
My menstrual cycle has made drastic and extremely painful changes immediately following receiving my covid vaccination. On May 19th 2021 (the first day of my period), I experienced abnormally intense and painful vaginal and anal pressure. The type and degree of the pain was unlike anything I had experienced in my life. The pain was so crippling, that at one point during the 48 hours of suffering, in an effort to make it to the bathroom, I collapsed on the floor and curled in the fetal position in pain and cried for about 30 minutes without any reprieve. In addition, I experienced an extreme pinching-like sensation and pressure in my anus throughout the ordeal and efforts to make a bowel movement were unsuccessful and excruciating to the point where I cried out in pain and had tears rolling down my face. Every month since receiving the vaccine, I also have heavier bleeding and larger blood clots than I have ever experienced in the 27 years of having my period. The flow is so bad that I leak at any moment and flood my undergarments.
DVT in right calf (popliteal, posterior tibial, peroneal veins)
second dose and third dose on 02JUN2003 and 13JAN2004; second dose and third dose on 02JUN2003 and 13JAN2004; This spontaneous report has been received from a physician via immunization record from a legal case in litigation (2307USA009419), concerning a 5-month-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were captured in 2307USA009419.  On 06-MAR-2003, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant) (manufacturer unknown) for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided). On 02-JUN-2003 and 13-JAN-2004, the patient was vaccinated with the second and third doses of hepatitis b vaccine (recombinant) (manufacturer unknown), respectively (inappropriate schedule of product administration).; Sender's Comments:  US-009507513-2307USA009419:
This spontaneous report was received from a registered nurse concerning on herself, a currently 79 year old female patient with Guillain-Barre syndrome (diagnosed in about 1989 or 1990 after received a dose of an unspecified Flu vaccine). The patient's medical history included muscular weakness and palpitations (in about 1989 or 1990 after received a dose of an unspecified Flu vaccine). On an unknown date, reported as "in the early 1990's", the patient was vaccinated with an unspecified dose of MERUVAX II (route of administration, anatomical location, lot number and expiration date were not provided). There were no concomitant medications reported. On an unknown date, about 1 hour after vaccination, the patient felt stomach sickness (abdominal discomfort). On an unspecified date, 1 week after vaccination, the patient recovered from abdominal discomfort. Then, starting about 1 week of vaccination, the patient developed chills, fever of 102.6F (pyrexia) and she also broke out in a rubella rash all over the body (rash rubelliform). The outcome of pyrexia, rash rubelliform and chills was reported as recovered, on an unspecified date, 2 weeks after vaccination. The reporter did not assess the relatedness of abdominal discomfort, pyrexia, rash rubelliform and chills with MERUVAX II. This is one of several cases from the same reporter. Additional information has been requested.
SINGS AND SYMPTOMS: REDNESS, SWELLING, AND FEVER AT THE INJECTION SITE. INFLAMMATION EXTENDED THROUGH A GREAT PORTION OF THE EXTERNAL AREA OF THE ARM.
Fever the morning after the injection. Temperature was 100.2 and faster pulse (90).
Got booster; Rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1), for Covid-19 immunization; Covid-19 vaccine (Dose 2), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Got booster"; RASH (non-serious), outcome "unknown", described as "Rash". The lot number for bnt162b2 was not provided and will be requested during follow up.
Initial information received from a healthcare worker provider on 16 September 2014. A 66 year old female patient was vaccinated intramuscularly on 08 September 2014 with FLUZONE High Dose, batch number U5019AA, site of administration not reported. At an unspecified time on the same day, she experienced a metallic taste in her mouth for 1.5 days after vaccination. The symptoms subsided on an unsepcified dat eand the patient recovered. The patient has a history of high cholesterol and hyperlipidemia. The patient was not ill at the time of vaccination. Concomitant medicaitons and laboratory tests were not reported. The patient outocme was recovered. Documents held by sender: None.
We noticed something was not quite right with our child at home immediately following birth. He was crying a lot. Once home he was screaming and we contacted the pediatrician and weye told it was colic. We continued with vaccinations on schedule. By around 1 year our child was having seizures when he would cry and it seemed like he was passing out. We contacted the pediatrician and we're told he was spoiled and was throwing temper tantrums. We continued with vaccines on schedule. His seizures became more severe and I asked my doctor if it could be the shots and he told me absolutely not that my child was trying to get attention. We continued with vaccinations. On 04/27/2012 after his last set of shots he was very listless and his seizures were terrible. We decided to stop vaccines altogether. He still has seizures. He has some neurological issues and development issues.
Huge itchy red latch, I have photos,  with bumps and very hot arm. It felt like there was a very warm compress under my skin.
Immediate lightheadedness, muscle aches, fever, extreme fatigue after H1N1 flu mist vaccine.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Additional Details: Patient took a tablet of Benadryl 25 mg due to a "funny" feeling of the upper lip, as well as some itching of the ears and face
On 9/22/14 client c/o right arm decreased ROM that developed shortly after receiving Hepatitis B vaccine on 6/24/14 and progressively worsened over 1 week after receiving vaccination and still continues to have decreased ROM when cleaning, taking off T shirt, etc. and intermittent pain after sleeping on right arm. Referred client on 9/22/14 to f/u with primary care provider for further evaluation and medical clearance for future vaccinations.
Information has been received from a RN concerning a 10 yr old female with no known medical history or allergies who on 26Feb96 was vaccinated with a 0.5mL dose of varicella virus vaccine live. There was no concomitant medication. On 10Jan06 the pt was seen with breakthrough chickenpox with 40 lesions. Subsequently, the pt recovered. No lab diagnostic tests were performed. There was no product quality complaint involved. Additional information has been requested.
I was not able to lift and rotate my left hand for last 6 months after my 2nd shot and I had reported to Pfizer and waited for 2 months and there was not response and then reached out my doctor and asked for help ..he mentioned it may be a inflamation and by doing exercise it will become normal and I did what doctor asked me to do so and still I have issue to lift and rotate my left arm .
sore arm after receiving the first dose; weak; She also had a half a day where she felt weak and tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm after receiving the first dose), ASTHENIA (weak) and FATIGUE (She also had a half a day where she felt weak and tired) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 021B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic (Insulin dependent). Concomitant products included INSULIN for Diabetes.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm after receiving the first dose), ASTHENIA (weak) and FATIGUE (She also had a half a day where she felt weak and tired). On 08-Mar-2021, ASTHENIA (weak) and FATIGUE (She also had a half a day where she felt weak and tired) had resolved. On 10-Mar-2021, PAIN IN EXTREMITY (sore arm after receiving the first dose) had resolved.
PATIENT RECEIVED TDAP AND HEP B ON 5/24/2010 AND ON 5/25/2010 PM HOURS AFTER BEING GIVEN TEST @ MEDICAL CENTER, SHE NOTICED A RASH ON LEFT SHOULDER, CHEST, AND EAR PLUS DEVELOPED DIARRHEA.  SHE ATE OUT ON 5/42/10 DIARRHEA ENDED 5/25/10.  SHE HAS AN APPT FOR EVALUATION ON 5/26/10.
Itching, hives on neck, ?itchy throat. Took PO Benadryl 6-7 hours later, slept, and symptoms were gone the next morning. Pt reported this on 4/25/13 at 0900.
Severe diarrhea for 8 hours; severe pain, left shoulder, with swelling.
Information has been received on from a nurse on 11-FEB-2015 referring to a patient of unknown age and gender. On 02-JAN-2015 the patient was vaccinated with a dose of PROQUAD (Merck) injection , 0.5 ml, subcutaneously(lot# was not reported) which underwent a temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 23-JAN-2012, the patient was administered with a dose of VARIVAX (Merck) (Lot # 0975AA, expiry date 17-JUN-2013) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
a little more painful, sustained pain in the arm; sniffles; a little bit of congestion; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a little more painful, sustained pain in the arm), RHINORRHOEA (sniffles) and NASAL CONGESTION (a little bit of congestion) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (a little more painful, sustained pain in the arm) and RHINORRHOEA (sniffles). 04-Mar-2021, the patient experienced NASAL CONGESTION (a little bit of congestion). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 09-Mar-2021, PAIN IN EXTREMITY (a little more painful, sustained pain in the arm) had resolved. On 11-Mar-2021, RHINORRHOEA (sniffles) and NASAL CONGESTION (a little bit of congestion) had resolved.            No concomitant medication information was reported.  The patient was waiting for kidney transplant. The patient enquired whether or not to get a third dose.  No treatment medication information was reported.
expired dose of Daptacel was administered/no ae; Initial information received on 25-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 5 months old male patient who received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and reported that expired dose of Daptacel was administered.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  On 25-Feb-2020, the patient received a dose (series 3) of suspect 0.5 ml DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5367AA and expiry date: 30-Jan-2020 via intramuscular route in the left thigh for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used.  At the time of reporting, It was unknown if the patient had any adverse event.  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 set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Patient broke out in hives on different parts of body. Has been using Benadryl to treat the itching and has not had any other complications.  Hives have yet to resolve.
High fever,headache,diarrhea,shortness of breath started on May 30th 2021,treated and cured on June 14th,2021. Sphincter weakness of urine and feces,lower limbs weakness numbness and zonesthesia,abdomen and lumbar numbness and zonesthesia gradually started from June 4th,which still has not been cured till now with over 3 months past. Based on the symptoms above,doctors think it might be acute myelitis caused by Vaccine. And I was given treatment of acute myelitis but I still can not get recovered. I am looking forward to your help.