chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 09-AUG-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N012491 with expiry date 17-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006208.
12/17: States she felt itchy on abdomen when she looked like she had a rash, then rash extended to arms and legs on 12/18.  She noticed welts, today 12/19/2003.  Welts subsided and rash soreness improved but still itchy.
Patient stood up from mothers lap after vaccination and fainted. Hit head on corner of wall. Skin was intake but immediate swelling the size of a quarter on center upper forehead. Patient left immunization clinic in stable condition after nurse assessment and ice pack given.
Patient received second dose of covid 19 vaccine two weeks after first dose. Not due until three weeks after first dose. Per CDC recommendations, dose needs to be repeated.
Believe 0.3ml dose was drawn for Moderna Bivalent dose vs that of a 0.5ml dose and adminstered to patient; patient made aware and notified of error; offered revaccination per CDC recommendations; patient declined
27NOV92 fever 103 ax, no appetite-doesn't seem to feel well; 28NOV92 t102 ax; 29NOV92 t100-rash appeared & listless; 1DEC92 to MD; has ear infection;
The first symptom was headache, followed by severe fatigue, loss of energy, and digestive discomfort. Later developed into difficulty breathing, tightness/pain in chest, silent reflux, chronic fatigue, dizziness, a full feeling in her throat, difficulty swallowing, heart palpitations, abdominal pain, loss of appetite, difficulty eating, nausea, body aches, weakness, especially in limbs, excessive bleeding during menstrual cycle, along with near-fainting, and vomiting, lumps in her breasts, rash on eyelids, which then spread to her chest, neck, scalp and right arm, pain after urinating, frequent urination, and kidney pain, moderate vaginal discharge/odor and pelvic pain.
Possible inadvertent inoculation of smallpox vaccine to L interal neck area. Pt has area covered and has only minimal lymph node swelling. Pt is well and wroking. Pt has h/o acne. Handwashing emplasized.
Disorientation; Low grade fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (Disorientation), PYREXIA (Low grade fever), CHILLS (Chills) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced DISORIENTATION (Disorientation), PYREXIA (Low grade fever), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, DISORIENTATION (Disorientation), PYREXIA (Low grade fever), CHILLS (Chills) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medication use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Updated the event outcome from unknown to resolved for all the reported events.
Was given Johnson & Johnson after receiving Pfizer 5 days ago. Received dose on 8/16/21 at 16;10. Lot number was 042A21A
Patient came into pharmacy requesting MMR vaccine. Prescription typed up as Boostrix, verified by RPh as Boostrix, and administered by Intern Pharmacist as Boostrix. Patient called pharmacy stating he was requesting MMR and not Boostrix. Reporting pharmacist explained to patient he had gotten Boostrix instead. Error report filed. Patient came back to pharmacy to get MMR.
This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 102 degrees) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 09L20A) for COVID-19 vaccination.   No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PYREXIA (Fever of 102 degrees). At the time of the report, PYREXIA (Fever of 102 degrees) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, Body temperature: 102 (Inconclusive) fever of 102 degrees.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Tested positive for PCR; Tested positive for PCR; This is a spontaneous report from contactable reporter. This reporter reporting for a 36-year-old female patient (reporters friend) that:  A 36-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on Jun2021 (Age at vaccination 36 years) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced tested positive for pcr on 23Jun2021. Reporter stated, her friend had the vaccine on Friday and now she tested positive for PCR. Reporter does not know if it is normal because of the vaccine. It is just the Pfizer vaccine. Her friend tested positive today 23Jun2021 and she doesn't know if it is from the vaccine. Her friend tested positive an hour ago, and they are concerned. She has been in contact with her friend. She doesn't know what Pfizer vaccine it was or what it was for. She just knows her friend received the Pfizer vaccine. She is not sure if her friend received the vaccine on Thursday or Friday of last week. She does not have an NDC, lot number, or expiration date. She thinks her friend had it in her left arm. The patient underwent lab tests and procedures which included sars-cov-2 test was positive on 23Jun2021.The outcome of events was unknown.  Information about lot/Batch number has been requested.
Patient reportedly received Moderna Vaccines 02/01/2021 and 03/01/2021. On 4/30/21 he had chest pain and was found to have inferior STEMI. He was transferred for further care. Upon further investigation he was found to be COVID-19 positive on 4/30/21 at 01:39 via COVID PUI LIAT testing of nasopharyngeal source. The patient was reportedly asymptomatic from COVID-19. He underwent thrombectomy and DES to RCA for STEMI. He was discharged home 5/2/21.
Admitted on 8/10/21. Had both doses Pfizer vaccine, the last on 3/5/21. Had positive COVID test 2 weeks prior at his PCP's office. Presents now with fever, sob, cough and diarrhea. COVID test positive on 8/10/21. Diagnosed with pneumonia and hypoxia due to COVID virus. Started on antibiotics and Remdesivir.  8/20/21: discharged
Received 2nd  booster on 4/23 On 5/24 started to develope upper respiratory symptoms On 5/26 tested positive for Covid via home test Self reported positive test on 5/27 Did televisit with PCP on 5/27 steroids and cough syrup provided On 6/2 did another televisit with pcp and antibiotic provided for secondary sinus/ear infection.Temp never > than 98.7 main symptoms extreme fatigue and relentless cough that turned into ear pain and green sinus drainage Still experiencing fatigue and recovering from secondary infection
Pain, swelling after 4 weeks-- given BACTRIM #20 for 10 days.
L arm, red, edematous, itchy at site of Varivax inj.  Rx'd with Augmentin 875mg 1 BID x10 days.
some of the vaccine leaked down his arm; During this IM injection part of the needle may have disconnected from the syringe and some of the vaccine leaked down his arm; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (some of the vaccine leaked down his arm) and DEVICE CONNECTION ISSUE (During this IM injection part of the needle may have disconnected from the syringe and some of the vaccine leaked down his arm) in an 84-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7165B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 07-Oct-2022, the patient experienced UNDERDOSE (some of the vaccine leaked down his arm) and DEVICE CONNECTION ISSUE (During this IM injection part of the needle may have disconnected from the syringe and some of the vaccine leaked down his arm). At the time of the report, UNDERDOSE (some of the vaccine leaked down his arm) and DEVICE CONNECTION ISSUE (During this IM injection part of the needle may have disconnected from the syringe and some of the vaccine leaked down his arm) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment details was reported. It was reported that the patient had received his 5th Moderna bivalent COVID-19 vaccine. Patient had not reported any symptoms.
Approximately 1 hour after immunizations administered, pt began complaining of "itching all over".  Mom noted bright red wheals on chest, spreading rapidly over torso.  Contacted MD administered Benadryl per mouth, continue to have redness and swelling at site.
cold; I have a little cough; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age (reported as 85, unit unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  On an unspecified date, it was reported that the patient was asking if he can get the 2nd dose of vaccine if he "has a cold". The patient also reported that "I have a little cough and I want to know if it is alright for me to take my second shot, I was supposed to take it in the morning, I have a cough and I wanted to know if is it all right me to take my second shot. I have a cold is it alright to take my second shot." The outcome of the events was unknown.   Information on lot/ batch number has been requested.
side effects of the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects of the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects of the vaccine). At the time of the report, VACCINATION COMPLICATION (side effects of the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment details were reported.
Pt recvd vax & devel sl palpitations, uncontrollable crying & could not raise arms above head;
gained about 3 pounds now; The next day, her cheeks, face, and the part under her chin became swollen/her body also became swollen; she feels something in her throat which she can't describe; she feels something in her throat which she can't describe; her vision on her good eye became a little depleted; inside of her lips was swollen; This is a spontaneous report from a contactable consumer. This 81-year-old Female consumer reported for herself that she received the first dose of (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) at single dose on 27Jan2021 for COVID-19 immunisation. Relevant history included food allergy. Relevant concomitant drug was unknown. The patient received her 1st dose on 27Jan2021 and stated that she was feeling fine for about 10 minutes and when she got back home which was not very far from the vaccination site, she noticed that the inside of her lips was swollen. She mentioned that this was not strange for her since she was mostly allergic to food but usually it was the outer portion of her lips that became swollen and not the inner portion. The next day, her cheeks, face, and the part under her chin became swollen and she felt something in her throat which she could describe. She also noticed that her vision on her good eye became a little depleted which got her a little concerned and her body also became swollen and stated that she already gained about 3 pounds now. She wanted to know if anyone had reported the same reaction she had and if it was recommended for her to get the 2nd dose or not. Outcome of events was unknown.  The information on the LOT/Batch number has been requested
After patient was placed to bed and cried out with an unusual cry/scream. Mother rushed to get her and picked her up. At that time patient became limp and unresponsive. Mother gave mouth to mouth breathing, which made patient cry. Then she became unresponsive again, which made the mother provide more mouth to mouth breathing. Again, patient started crying but also became unresponsive for a third time. In the meantime the father called 911. Upon arrival patient still seemed lethargic so she was taken to Emergency Room.
bad reaction; This case was reported in a literature article and described the occurrence of adverse reaction in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced adverse reaction (serious criteria hospitalization). On an unknown date, the outcome of the adverse reaction was unknown.   The reporter considered the adverse reaction to be related to Flu vaccine.  Additional details were reported as follows: This case was reported in a literature article and described the occurrence of bad reaction, in a female patient of unspecified age, who was vaccinated with unspecified flu vaccine (manufacturer unknown) for prophylaxis. This case corresponds to Participant reported in this literature article. The patient was a part of study that aimed to understand how the vaccine decision-making process differed between parents with a child diagnosed with autism and parents with a child that did not have autism. Interviews were conducted in September-December 2018 with 24 racially and demographically diverse parents of children at two clinics serving patients, one of which only serves families of children with autism. [In this study, 24 parent participants were interviewed. The majority were female (92%), and aged 40-49 years (46%). Fourteen parent participants had children with autism interviewed (ASD), and the remaining ten had neurotypical children]. The patient was at least at least 18 years of age and currently had a child who had ASD. No information on patient medical or family history or concurrent condition or concomitant medication was reported. On an unspecified date, the patient had unspecified Flu vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age at vaccination was not reported.  On an unknown date, an unspecified time after vaccination, the patient had really bad experience with the flu vaccine to the point where the patient was hospitalized for a week after one time. The patient reported to have a really bad reaction. After that, patient had never given her child a flu vaccine, neither one of them. The case was considered as serious due to hospitalization. Treatment was unknown. Outcome was not provided. The authors stated "From our results, parents of a child with autism were more likely to consider the idea that vaccines were linked to autism in their decision-making process, and were less likely to be influenced by personalized recommendations from the child's health care provider. In our study, we found that concerns about vaccines, the parent provider relationship, and risk perception were most salient".
This case was reported in a literature article and described the occurrence of abducens palsy in a 20-month-old male subject who was vaccinated with DTPa (manufacturer unspecified) and Hib. No information has been provided on the subject medical, family history or concurrent medication. On an unspecified date, the subject received an unspecified dose of DTPa (administration site and route unknown, batch number not provided) and an unspecified dose of Hib (administration site and route unknown, batch number not provided). 3 weeks after vaccination with DTPa and Hib, the subject experienced abducens palsy (left eye). After 2 to 3 months, the episode resolved. This case was assessed as medically serious by GSK. At 31-month-old, 2.5 weeks after varicella, the abducens palsy recurred. No information has been provided on the clinical examinations performed on the subject during any of the episodes. The authors report that he underwent an MRI and a acetylcholine receptor antibody testing at some point but the results have not been provided. At the time of reporting, the event was improved. The author's conclusion stated that their review corroborated their findings that all patients who had benign sixth nerve palsy temporally related to vaccination had at least one recurrence.
Pt states reoccurrence of Reitens Disease after 3rd TYPHOID pill - c/o S-1 pain resolved post backs required steroid use Last episode of Reitens disease was 5 years prior- pain in wrist.  Pt reported event today 2/6/09
Patient was administered the FLUZONE QUAD shot and two minutes after, she looked faint, and fell over from the chair. Patient was shaking and losing consciousness and looked as though she was going through a seizure. Pharmacist repeatedly asked the patient if she was okay, if she could hear her, and if she can breathe, and laid the patient on her side. She called her technician over for help and once technician saw the situation, she asked pharmacist if she should call 911. Pharmacist answered yes. The patient started shaking again for another 10 seconds or so, and then regained consciousness. Pharmacist and technician helped the patient sit up (on the floor) and the patient could not recall what had just happened. Pharmacist explained that the patient fainted and asked the patient if she has any seizure disorders or taking any seizure medication. The patient answered no. Pharmacist informed the patient that the paramedics were on their way, but the patient expressed that she did not want the service. Pharmacist replied that she is unable to cancel because the paramedics were already on their way. The patient's hands were clammy and asked for water, but at this point, technician was on the phone with the 9-1-1 operator and was ordered not to give the patient any food or water. The operator also instructed technician to lay the patient on her left side, so pharmacist and technician was in the process of helping the patient stand up when the patient went through another shaking episode (which lasted around 10-15 seconds). After she came to, they explained to the patient that the operator instructed for them to place her on her side, lying down until the paramedics arrive. She consented. Pharmacist asked the patient if she wanted to contact anyone and the patient proceeded to call her mother on her phone. The paramedics arrived and did a workup on the patient and suggested that the patient go with them to get a full workup done, but the patient refused, and signed the electronic waver that the paramedics had on their computer. The patient stated that she usually gets very faint when she gets shots and that she felt fine at that moment. Pharmacist signed as a witness. The patient left the consult room afterwards.
gastrointestinal symptoms to include severe abdominal pain, nausea, vomiting that lasted four hours with a headache and body mylagia.  Stomach pain persisted for 24 hours
Exhaustion set in about six hours following the appointment on 4/1. Slept rest of day and then slept most of 4/2 and 4/3. Not as exhausted after that but still persistently tired days following. Shortness of breath set in 4/7, got bad on 4/8. Made use of inhaler.
Flu-like symptoms. Muscle cramping in the left leg. Continuos period with heavy blood clotting.
Presents to the ED c/o abdominal pain. Pt states she gets abdominal pain that radiates into her chest, back, and neck associated with SOB whenever she exerts such as walking around or doing laundry. Incidental finding of COVID-19+, asymptomatic
Left arm red and swollen at deltoid x 2 days. Warm compresses Tylenol prn.
Patient reported to the ED after eruption of purpuric rash. Found to have platelet count of 23 and developed moderate neutropenia to an ANC of 910. Clinically well. No treatment. Within 12 hours the platelet count rose to 43,000 and the ANC rose to 2100. Thought to be immune thrombocytopenic purpura with atypical feature of neutropenia.
Information has been received from an 18 year old female with sulfonamide allergy, who in December 2007, was vaccinated with a first dose of COMVAX. Concomitant therapy included hormonal contraceptives (unspecified). In April or May 2008, after her third vaccination with COMVAX, the patient experienced about 6-7 seizures before she was hospitalized for a few hours. The patient also experienced abdominal bleeding. MRI, "catscan", nervous system tests and blood work were performed (results not reported). No lot number was provided. Subsequently, the patient recovered in July 2008 (date not specified). No further information is available.
PATIENT REPRESENTATIVE WAS IN THE STORE THE DAY AFTER THE VACCINATION (9/14/2019) AND SAID THE PATIENT WAS COMPLAINING OF PAIN/SORENESS AT INJECTION SITE OF SHINGRIX.  I EXPLAINED THE SITE WOULD BE SORE FOR A DAY OR TWO FOLLOWING ADMINISTRATION.  TOLD HIM TO KEEP ANY EYE ON THE SITE FOR ANY FURTHER SYMPTOMS.  PATIENT CAME INTO THE PHARMACY TODAY (9/16/19) AND SHOWED ME HER ARM.  THERE WAS REDNESS AND SWELLING BELOW THE INJECTION SITE AND IT WAS WARM TO THE TOUCH.  SHE SAID IT WAS STILL SORE AND SOME OF THE SORENESS MOVED UP INTO HER NECK.  SHE SAID SHE WAS AT THE PCP OFFICE TODAY AND THEY TOLD HER IT WAS AN ALLERGIC REACTION TO THE SHINGRIX VACCINE.