chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse via physician and medical assistant regarding a patient of unknown age and gender. The patient's medical history, current conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ROTATEQ lot # M038724 with unknown expiry date, (strength, dose and route of administration were not reported) for prophylaxis. The vaccine was exposed to 31 Fahrenheit degree (F) or colder (25F) for 1 hour 53 minutes and 47 Fahrenheit degree (F) to 77 Fahrenheit degree (F) (49F) for 3 hours 59 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects reported. There was no product quality complaint (PQC) involved. This is one of the several reports received from same reporter. Sender's Comments: US-009507513-1708USA003308: US-009507513-1709USA011730: US-009507513-1709USA011731: US-009507513-1709USA011732: US-009507513-1709USA011733: US-009507513-1709USA011734: US-009507513-1709USA011735: US-009507513-1709USA011737: US-009507513-1708USA003070.
pt recv vax 23OCT 247PM & exp swelling (530PM), became warm to touch w/large bruised area w/clear area and then red outside area;25OCT96 bruised area 14cm in diameter;erythema measures 16cm in diameter;
Marked sore arm which developed parasthesias 18 days after injection Patient here complaining of numbness and weakness to left arm after receiving flu vaccine 2 weeks ago. Patient states that the numbness radiating into left hand and pain radiating into left shoulder and up into her neck. Patient states that arm feels heavy and weak. Pain to injection site when pressure is applied. Had injection in her left deltoid on Wednesday Oct 21 at Pharmacy. Felt sore the next day, "like I would expect" but pain never resolved. On Thursday October 29 she developed diarrhea and has this, along with a headache on Thursday, Friday, Sat and Sunday. Yesterday, stools were formed but pain in the arm markedly escalated with throbbing pain and radiation moving into the neck and hand on the left side. The patient is a 39 year old female who presents with a complaint of Arm pain. The onset of the arm pain had been sudden and has been occurring in a persistent pattern for 18 days (but markedly worse the last 48 hours). The course has been increasing. The arm pain is described as moderate.
Pt claims that she had fever, chills, chest congestion and red eyes - with yellow discharge same after the vaccination administered.
Pt received seasonal flu vaccine 11-5-14 RD; Began having Rt arm pain from shoulder to wrist 11-6-14; Noticed lymph nodes enlargement on 11-6 as well. Weakness, headache, burning eyes, pain and stiffness to (R) side of neck, congestion began pm of 11-6; no fever.
Information has been received from a 16 year old female patient concerning herself with no pertinent medical history and no known drug allergies/drug reactions who on 06-MAY-2009 was vaccinated with the first 0.5 mL dose of GARDASIL (Lot # not reported). The patient received her second dose of GARDASIL on 07-JUL-2009. There was no concomitant medication reported. It was reported that the patient experienced stomach pain and not having menstrual period after she got the first and second dose of GARDASIL. The last menstrual period date was on 04-MAY-2009. The patient sought unspecified medical attention. There were no diagnostic laboratory tests performed. The outcome of the patient was not reported. No further information is available.
Information has been received from a physician concerning a 64 year old male patient with type 2 diabetes mellitus, hyperlipidaemia, hepatitis C antibodies with undetectable viral levels, hypertension and erectile dysfunction who on 22-APR-2009 was vaccinated with ZOSTAVAX (Merck) (Lot # 664028/0137Y) subcutaneously into the left arm.  On 27-APR-2009 the patient developed pain in his right leg as well as itching.  He had been diagnosed with shingles.  There were no laboratories diagnostic studies performed.  The patient sought medical attention office visit.  Follow up information has been received from a physician concerning the patient, a veterinarian, with no drug reaction or allergies and an unknown history of chickenpox, with no recent exposure to chickenpox or shingles, who on 24-APR-2009 (previously reported as 22-APR-2009) was vaccinated with a dose of ZOSTAVAX (Merck) (lot #664028/0137Y) SC in the left arm.  24 hours after vaccination on 25-APR-2009 the patient developed a vesicular rash with 25 lesions distributed on right front and lateral thigh, along dermatomes L3 and L4 on right thigh.  The patient was still getting new lesions.  Patient had a pain (4 in scale 0-10) at site of lesions.  There was no temperature and no other systemic symptoms.  The patient had not recovered.  The patient was enrolled in a Identification Program to identify if VZV is present and if it is present to identify if it is associated wit the wild type (WT) strain or with the Merck vaccine VZV strain.  The sample of the vesicular lesion on the right this was collected on 04-MAY-2009.  Follow-up information was received which reported that the PCR results for the specimen from the vesicular lesion identified the presence of wild-type VZV.  Additional information is not expected.
no adverse effects; patient received improperly stored VARIVAX; This spontaneous report was received from a registered nurse concerning to a 15 months child patient of an unknown gender. The patient's pertinent medical history, concurrent conditions, drug allergies or reactions, historical and concomitant drugs were not reported.  On 25-JUN-2019, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot number R017640, with expiration date on 20-JUN-2020 (dosage schedule, route and anatomical location were not reported), for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent.  Administered doses of vaccine experienced temperature excursion between 6 to 14 degrees Fahrenheit (12 F) for 4 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA004715: US-009507513-1907USA004719:
Patient received Moderna booster dose, 0.25 ml. She is 16 years old and Moderna is not approved for individuals under the age of 18.
This case was reported by a consumer and described the occurrence of difficulty in standing in a 64-year-old female patient who received FLUARIX QUADRIVALENT 2018-2019 season) for prophylaxis. Previously administered products included Influenza vaccine with an associated reaction of adverse event (refer case US2018GSK214203). On 16th November 2018 12:15, the patient received FLUARIX QUADRIVALENT2018-2019 season .5 ml. In November 2018, less than a week after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced difficulty in standing and walking difficulty. On 16th November 2018, the patient experienced low back pain and buttock pain. On an unknown date, the outcome of the difficulty in standing and walking difficulty were recovering/resolving and the outcome of the low back pain and buttock pain were not recovered/not resolved. It was unknown if the reporter considered the difficulty in standing, low back pain, walking difficulty and buttock pain to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were provided as follows: This case was reported by the patient. Immediately afterwards (after vaccination), the patient returned to home and laid down because she usually experience a mild reaction to the flu shot. She dozed off and when she tried to get up appx two hours later, I had excruciating lower back pain (below the kidneys, in the upper right buttock). For the next several days, she could barely walk and had extreme difficulty getting up or sitting down. It seems to be improving as of date of reporting date but was still causing some pain. The patient called the pharmacist who administered the shot to ask if anyone else had reported such a side effect. He said no, not in all his years of giving the flu shot had he heard of anyone having such a reaction, and it must be from something else. But, the patient had done nothing else; no lifting, no twisting, nothing that could hurt her back. The patient did not know if the flu vaccine caused this side effect, but if no one reports it, it would never know. So, she reported it as a possible side effect. The patient received the shot through the program. This case has been linked with case US2018GSK214203, reported by same reporter for same patient.
Left arm with redness and swelling, 2 days after shots with fever to 102.7F. Treat symptoms with Benadryl, Tylenol or ibuprofen.
sore arm x2 days; This is a spontaneous report from a contactable consumer (patient). A 47-year-female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 20Jan2021 16:15 (lot number: el3248), via an unspecified route of administration in the right arm at single dose for COVID-19 immunization in the workplace clinic. The patient's medical history was not reported. The patient's concomitant medication included hydrochlorothiazide, quinapril hydrochloride (ACCURETIC). The patient did not receive other vaccines within four weeks. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested after the vaccination for COVID-19. The patient experienced sore arm x2 days on 21Jan2021 at 07:00 AM. The patient did not received treatment. The consumer assessed the event as non-serious. The outcome of the event was recovered in 23Jan2021.  No follow-up attempts are possible. No further information is expected.
Hot and cold; sore arm; chills; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administration date 29Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING OF BODY TEMPERATURE CHANGE (non-serious) with onset 2021, outcome "unknown", described as "Hot and cold"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "chills"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Fatigue".  Additional information: The patient is scheduled to get the second one on 19Apr2021. She added she has to travel the day following the injection and asked if she should receive the second dose earlier than scheduled. Caller explained she had a "sore arm" and "fatigue" after getting the first dose, and she "doesn't remember anything major" after that. She said 2 weeks after the shot she then felt "hot and cold" and had "chills". Caller asked: is feeling hot and cold and getting chills 2 weeks after getting the first dose of the Pfizer-BioNTech COVID-19 vaccine related to the vaccine. Responded per attachments. Used section "Safety: Adverse Reactions or Side Effects" of the VR-Consumer Inquiry Management (Off-Label or No Info). Frequency and Percentages of Participants with Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After Each Dose- Participants 56 Years of Age and Older - Reactogenicity Subset of the Safety Population " from the Full EUA PI, LAB-1457-7.0 revised: 6Apr2021. "Side effects that you may experience throughout the rest of your body; (systemic side effects) including fever and chills were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter" from CONS -How long side effects last final.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
SOUGHT CARE AT ER WITH C/O VOMITING, NOT BEING ABLE TO WALK, CHILLS, FEVER, COUGH, CONGESTION. NEGATIVE FOR COVID-19. ADMITTED FOR IV ANTIBIOTICS AND SUPPORTIVE OXYGEN THERAPY. DISCHARGED 2 DAYS LATER. TREATED WITH ZITHROMAX IV, ROCEPHIN IV, O2, ACETAMINOPHEN, HIGH-FLOW NEBULIZERS
CELLULITIS, PATIENT WAS GIVEN ANTIBIOTIC CEPHALEXIN.
Itching and redness around injection site.  Redness continued to expand to 6 cm x 8cm over next few hours.  Became hot and firm.
TD shot on 08/17/01 on the 3rd day post vaccination this patient developed a rash on his trunk, palms, soles, arms and legs, afebrile.
pt recv vax 18JUN97 & 21JUN97 pt devel a rash on lt arm consisting of mult vesicles in clusters along the T1 dermatome (shingles);
Started bleeding like it was my  menstrual  cycle around two weeks early as I had a period two days after I got the first shot and now am bleeding again. My periods have been normal up until this and this doesn't seem like a normal period. I?m not bleeding a lot but it stops and then starts again.
Patient states hearing loss after first dose, but recovered. Patient got second dose, experienced hearing loss again, but has not recovered again. Patient states small amount of hearing loss.
he got numbness and tingling in the nose and mouth area; Caller states everything felt like it was blowing up but it actually wasn't; he got numbness and tingling in the nose and mouth area; muscle soreness and weakness; muscle soreness and weakness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administration date 14Jun2021 (Lot number: EW0177) as dose 1,single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: he was on blood pressure pills,, he was on an antibiotic.; "Cholesterol" (unspecified if ongoing), notes: he was on cholesterol pills. The patient took concomitant medications. The following information was reported: HYPOAESTHESIA ORAL (non-serious), PARAESTHESIA ORAL (non-serious) all with onset 14Jun2021, outcome "recovered" (15Jun2021) and all described as "he got numbness and tingling in the nose and mouth area"; FEELING ABNORMAL (non-serious) with onset 14Jun2021, outcome "recovered" (15Jun2021), described as "Caller states everything felt like it was blowing up but it actually wasn't"; MYALGIA (non-serious), ASTHENIA (non-serious) all with onset 14Jun2021, outcome "recovered" (Jun2021) and all described as "muscle soreness and weakness".  Additional information: COVID shot, clarified to vaccine, and he wanted to find out what it was that he is experienced so that he can proceed with the second one. 5 minutes after he had the COVID vaccine he had numbness and tingling in his nose and in the mouth area, it was like when you have Novocain, and it felt like everything was blowing up but when he looked in the mirror it wasn't blowing up, it was just the sensation of what was going on. That was basically it for his immediate reaction. Then after that he had the normal side effects later in the day such as muscle soreness and weakness. Those he was expecting to have but it was the reaction that he had five minutes afterwards that he had that he wasn't expecting. He wants to find out what that was, was it an allergic reaction or something else?   No follow-up attempts are possible. No further information is expected.
Extreme flu-like symptoms.  Severe and debilitating headache and body aches.
pt recv vax 27JAN97 & 7FEB97 pt exp a sore throat & fever;5JUN97 pt devel less than 10 lesions on chest;pt was treated w/calamine lotion;8JUN97 pt recovered;
bad fatigue/ tiredness; pounding headache; chills/ the shakes; sweats/ hot sweats; cold sweats; aches and pains; dry mouth; her energy level is even worse to where she can hardly get up to go to the bathroom.; Muscle pain; swelling of the arm where she got the injection; not feeling well and not herself/ I have been very sick with the first dose; not feeling well and not herself; loss of appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administered in arm (Lot number: EN6206) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cholesterol" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Concomitant medication(s) included: PANTOPRAZOLE; ATORVASTATIN taken for blood cholesterol abnormal; SYMBICORT taken for asthma. The following information was reported: FATIGUE (non-serious), outcome "not recovered", described as "bad fatigue/ tiredness"; HEADACHE (non-serious), outcome "not recovered", described as "pounding headache"; CHILLS (non-serious), outcome "recovering", described as "chills/ the shakes"; HYPERHIDROSIS (non-serious), outcome "recovering", described as "sweats/ hot sweats"; COLD SWEAT (non-serious), outcome "recovering", described as "cold sweats"; PAIN (non-serious), outcome "recovering", described as "aches and pains"; DRY MOUTH (non-serious), outcome "not recovered", described as "dry mouth"; ASTHENIA (non-serious), outcome "unknown", described as "her energy level is even worse to where she can hardly get up to go to the bathroom."; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "swelling of the arm where she got the injection"; MALAISE (non-serious), outcome "not recovered", described as "not feeling well and not herself/ I have been very sick with the first dose"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "not feeling well and not herself"; DECREASED APPETITE (non-serious), outcome "unknown", described as "loss of appetite".  Additional Information: The patient reported that the first three days were really bad with fatigue, headache, chills, sweats, aches and pains. The reporter mentioned that being 74 year old, her energy level was not great to begin with. She asked how long will her symptoms last because it was 5 days already and she was still not feeling well. The patient did not want to get the second dose because she have been very sick with the first dose. The reporter asked if it was safe for her to get the second dose because she does not want to go through these (the events) again. Second dose was scheduled for 03Apr2021. The patient was advised to get in touch with her primary doctor to see what he has to say about it.  No follow-up attempts are possible. No further information is expected.
Patient tested positive at hospital on 01/07/2022.  Admitted to hospital on 01/10/2022 with symptoms: Fatigue, difficulty breathing.  Patient has multiple underlying health conditions: obesity, diabetes and hypertension.  He may have been transferred to bigger hospital as he was tested again for Covid on 01/23/2022: positive.  Patient died on 01/24/2022.  This charting of information comes from case profile.
Contracted COVID-19 ~1 month later, tested positive on 5/16/21. Died 6/9/2021 at 94 years old. Had CLL diagnosed during final hospitalization, thought to have caused poor vaccine response and susceptibility to COVID.
Covid19 breakthrough.  1st vaccine recieved on 07/31/2021.  59 y/o with no PMHx presents to ED with 3 day history of Right arm weakness that progressed to Difficulty getting words out, expressive aphasia, dysarthria.  CT revealed Left PCA stroke.  Pre procedure Covid test +.  Pt asymptomatic, room air sats 96%, afebrile.  No covid treatment ordered, monitoring.
very itchy skin; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (very itchy skin) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (very itchy skin). At the time of the report, PRURITUS (very itchy skin) outcome was unknown.            No laboratory data was provided.  Relevant concomitant medications were not reported.  Treatment information was not provided.
This spontaneous prospective pregnancy report was received from an adult, pregnant female patient of an unknown age (reported as "almost 40 years of age") who was reporting on herself. The patient was scheduled to receive and unspecified TDAP vaccine on 29-SEP-2016, but she was administered a dose of unidentified Merck HPV vaccine reported as GARDASIL or GARDASIL 9 (dose, route of administration, lot # and expiration date not reported) in error instead of the TDAP. The patient was 28 weeks pregnant (in her third trimester) at the time of vaccine exposure. Her Last Menstrual Period (LMP) date was calculated (by subtracting the number of weeks of pregnancy from the date of vaccination) to be 17-MAR-2016 and her estimated delivery date (EDD) was 22-DEC-2016. Pregnancy outcome was pending and fetal outcome was unknown. The patient learned of this error at an unspecified time during the week of 17-OCT-2016. The administration error was discovered when the medical office listed in this case was doing a routine inventory of their vaccinations. The inventory "was off". The office traced the error "back to the patient's chart" and contacted the patient. No adverse reaction was reported. Additional information has been requested.
Patient came in for 2nd dose of Moderna. His 1st dose was 12/6/21. He 2nd dose was not due and I didn't catch it.
Information has been received from a pharmacist concerning a 22 year old patient of unknown gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 11-MAR-2016 the patient was vaccinated with an expired dose of GARDASIL, lot # J007354, expiration date 20-FEB-2016 (route unspecified) (expired product administered). No adverse effects had been reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Pain in left arm initially toward the coller bone that did subside after a day and confirmed with the patient that the shot was given in the middle deltoid. but now patient has noticed swollen lymph nodes. pt is going to continue to monitor and if it proceeds to get worse she will go into a urgent care
After 2nd dose, pain in arm did not subside, it became increasingly worse. Within 2 days i could not  raise arm, as the days passed arm became stiff and extremely painful- to the point that I could not dress, bath, put on deodorant, wash hair, etc. without assistance.   I made appointment with Orthopedist and was told that I had Adhesive Capulitis.  I was given injections and unfortunately that has failed to yield any relief.  It has actually gotten worse.  I am a very healthy, fit individual and this is impeding and affecting my everyday life.  It is extremely painful.  The pain radiates from my shoulder to my neck, breast, down to my elbow and wrist.  Nothing provides relief.
Fever for first 3 days Body/muscle aches for 3-4 days Fatigue that has not gone away Random headache off and on Occasional dizziness/light headedness, has gotten better over time but still occurs Rapid heartbeat at times
1st symptom extreme pain in neck and shoulder of arm injected.  Next 4 days, headache, nausea, body aches,  loss of appetite,  fatigue
Pt vaccinated with DTP/OPV started vomiting, fever of 103F, couldn't walk on rt leg where immunization given. Leg was swollen, red, & hot to touch. Also rash on both arms & thigh where imm given. Taken to ER dx vaccine reaction.