chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient vaccinated 10/8/2010 at OSH. Patient developed skin rash consistant with chicken pox per report approx. 3 weeks after vaccination. Patient developed eye pain and redness approx. 6-8 weeks after vaccination in both eyes, progressing to blurred vision and some vision loss. Symptoms resolved in left eye, but not right. Patient admitted to faclility with final diagnosis of progressive ocular retinal necrosis. Viral testing showed VZV in intra-ocular fluid by PCR. Patient found to be HIV positive at time of admission with CD4 of 15 and viral load of 315,000.
At night her face had swelling which was only in her face; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 61-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via an unspecified route of administration on 18Mar2021 as dose 2, single (at the age of 61-years-old) for COVID-19 immunization. The patient previously received first dose of BNT162b2 (COMIRNATY, Solution for injection) via an unspecified route of administration on an unspecified date as dose 1, single (at the age of 61 years old) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced at night her face had swelling which was only in her face on 18Mar2021 (reported as ongoing). Patient wanted to know what she should take or what is the cure for the swelling or is this normal. The outcome of event was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Tinnitus began @ 3 weeks after shot Also have had calf cramping from about 10 days after shot.  Not sure if calf is related.
It starts with the telltale sore injection site (right arm for me).  Then tremendous chills (unable to get warm regardless of the amount of bedcoverings) for hours.  Tremendous tiredness all the next day, with some dizziness and breathlessness, because hey, why not.  Basically, starting from 10 pm or so on the night of the vaccine, I was out of commission for the next 36 hours.  I spent most of that 36 hours sleeping (once I was able to--it took me til somewhere between 2-4 am to fall asleep on the first night because I was so cold).   Anytime I got up to drink water or eat, I was so totally exhausted that there was nothing to do but go back to sleep.  Shot was Friday  afternoon at 3 pm.  Sunday morning (which was Easter), I poked my nose out of the covers about 9 am, and found I was alive again.  Took a shower for the first time since Friday morning, went to service, and was fine. This is the first time I am bothering to report side effects, but it has been basically the same drill for all 4 shots--this time around was slightly milder than the other 3 times.  Still,  I was useless between Friday night and Sunday morning. For what it's worth, I had a similar reaction to the shingles vaccine (shingrix, 2 dose, both doses nasty), and usually get a heck of a sore arm after a flu shot.
Pt c/o of swollen left leg from mid thigh down below knee. Site is red and warm to touch. Pt was limping.
diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Blood in urine and kidney ache. They same thing happened with the first dose and lasted about two weeks.
Information has been received from a physician referring to unspecified patients of unknown age and gender. Information about medical history and concurrent conditions were unspecified. On an unknown date the patients were vaccinated with improperly stored doses of oral ROTATEQ (lot # L013193, expiration date 20-JAN-2017, dose and route were unknown). The temperature excursion for the vaccine was 47 F, time frame was 36 hours. There was no previous temperature excursion. It was not because of a "data logger". No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
HEADACHE,  MUSCLE PAIN, FATIGUE,SWELLING IN THE VACCINE AREA,
No adverse signs after initial injection.  On 12/28/21 (13 days after getting my booster), I woke up with a very itchy rash on my abdomen.  Over the next few days, I would break out in a rash at different places all over my body that would be extremely itchy.  I went to my PCP on 12/30/21 and she did a strep test and I tested positive for strep, and she thought I had scarlet fever.  I was given amoxocillin and  a steroid and then developed an even more extreme rash on 1/7/22 that was all over my body and went to urgent care.  I tested negative for mono there, and they thought I was having an allergic reaction to amoxocillin.  I returned to my PCP on 1/13/22 and they retested me for strep and I tested positive again despite the antibiotics and was prescribed a Zpac.  My rash finally cleared by 1/21/22 and they did additional testing and determined that I also had Parvo at some point during that time period.  They ultimately determined that they thought the rash was caused by strep and possibly parvo interacting with the amoxocillin but I did test negative for an amoxocillin allergy.  I doubt that all of this was related to my Moderna booster, but I answered about an adverse health event on Vsafe b/c it had occurred less than 2 weeks after getting my booster so I just wanted to make note of it.
3 year old female 1 week S/P immunization. Now with erythematous, warm area at site of immunization in right thigh mildly tender but improved today per treating physician, per history.
R thigh was warm to touch, swollen. Baby had it tucked up to chest. Mom reports baby screaming for 15-20 mins continuously. Mom gave Tylenol, reported doing better shortly there after.
Patient presented to 2 different pharmacies - Received first moderna on 8/3/21, went to a different pharmacy and received Pfizer on 8/23/21, then came back to the original pharmacy and received her second Moderna vaccine on 8/31/21 without disclosing her recent vaccine history to either pharmacy.
Case number PHEH2016US023417 is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 48 year old patient whose gender was not specified. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml intramuscularly in the left arm on 31 Mar 2016. It was reported that the patient received FLUVIRIN multi dose vial (MDV) that had been exposed to 8 to 10 temperature excursion. The patient did not experience any adverse events following vaccination.
Slight nausea, fever of 102, severe chills, sever aches and joint pain.
Moderna vaccine, first shot 4/9/21, second shot 5/7/21. After the first shot, within 36 hours I broke out in a rash around my knees, inside and outside. Very itchy with small red pimples, no pus. Nurse at the clinic suggested it was an eczema. However, within 36 hours after the second shot, the rash became more serious, spread wider around my knees, legs, thighs, neck, arms, lower back and buttocks. It is unbearably itching and persisting. It clearly is my bodies response or allergy to the vacinne.
pt recv vax 21NOV98  10AM-3PM & exp itchy skin, rash to top chest & neck-dizzy, h/a;thurs AM hives, upper chest, neck area;Friday AM rash chest, rib cage, abd, upper arms;Mon AM rash elbow to fingers;
Patient's mom complained to dr. stating that patient received 2 shots on left arm and developed a big welt after that then went away.
Within 15 min of receiving the vaccination she began to be itchy and her arm swole right leg began to itch and her ears began to burn, hives around the lips. She said her chest felt tight. She received 25 mg of Benadryl.  After 20 minutes she received another dose of Benadryl.
Vaccine administered was 4 days past beyond use date. Spoke to patient to inform him and see if any adverse reaction. Patients states feeling achy after receiving shot but recovered from that. He was traveling today and feels a headache sore throat backache and upset stomach resulting in diarrhea. He does not think it was from vaccine but I told him I would report it any way.
This case was reported by a healthcare professional and described the occurrence of occupational exposure to HIV in an adult female subject who was accidentally exposed to Havrix. On 08 November 2006 the subject, a healthcare professional, was injecting a dose of Havrix into an individual who is HIV and hepatitis B positive. During the administration of Havrix, while "the needle was in the individual's arm," the syringe "spurted fluid." The fluid spurted back into the eyes and nose of the healthcare professional. As a result of the fluid spurting, the healthcare professional was exposed to HIV and hepatitis B and also was accidentally exposed to Havrix. The healthcare professional was treated with Kaletra and Truvada for HIV post-exposure prophylaxis. The outcome of the events was not reported.
Case previously recorded as MA2009-3520. Initial case report received from a physician via MedCom on 03 NOV 2009. A 2-year-old male patient was vaccinated with 0.5 ml S-OIV FLUVIRIN (batch no. unknown) i.m. on 03 NOV 2009. No adverse event was reported. MedCom reference no.: NA09-007451.
Patient began not feeling well 5 hours after the injection. She became pale and sweaty. She  collapsed on her way into the ER. Her blood pressure dropped too low. She became severely dehydrated. She needed a bag of fluid. Her body was hot. She was shaking uncontrollably because she was cold.
Headache, mild nasea, fatigue,    PRIMARY CONCERN:  sharp pain between shoulder blades, high center back
Patient had already received 1 dose as an infant; Administered  Bexsero instead of Menveo; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old female patient who received Men B NVS (Bexsero) (batch number 59M3M, expiry date 28th February 2023) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, Men B NVS (Bexsero) for prophylaxis and meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd August 2022, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 3rd August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were 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: 03-Aug-2022 Reporter's ccomment: The certified medical assistant stated that the patient was supposed to get Menveo but was inadvertently administered  Bexsero instead on the day of reporting.  The reporter stated that the patient had already received 1 dose of Bexsero as an infant, and the dose on the day of reporting was a double dose. When asked if the patient received both doses of the Bexsero in the past, and if this was a 3rd dose, she was not able to confirm. The reporter tried to call the health care professional back to confirm the patient received Bexsero as an infant, but unable to reach her.  The reporter consented to follow-up via postal. Additional supportive information: The patient had already received 1 dose of Bexsero at inappropriate age, which led to inappropriate age at vaccine administration. The patient received was supposed to get Menveo but was inadvertently administered  Bexsero instead, which led to wrong vaccine administered.
shingles on her face/ shingles spreading to her eye.; runny nose; cough; 10 pustules on her forehead and they are crusting over; could hardly walk or move" and could barley do her PT exercises.; severe pain; burning" in her back, and down her right leg to the top of her ankle/ felt like her body was on fire/felt like her body was "inflamed"; Initial information received on 24-Sep-2021 regarding an unsolicited valid non-serious case received from other healthcare professional and consumer/non-healthcare professional via call center via Agency (Reference number- 00632994).  This case involves a 66-year-old female patient who experienced severe pain (pain), burning in her back, and down her right leg to the top of her ankle/ felt like her body was on fire (burning sensation), shingles on her face/ shingles spreading to her eye (herpes zoster), runny nose (rhinorrhoea), cough, 10 pustules on her forehead and they are crusting over (pustule) and could hardly walk or move and could barley do her pt exercises (gait disturbance) after she received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's medical history, vaccinations, concomitant medication and family history were not provided. Patient has had a knee surgery in the past without further detail.  On 13-Sep-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date not reported) via an intramuscular route at an unknown administration site for prophylactic vaccination.  On 15-SEP-2021 the patient developed a non-serious severe pain (pain), burning in her back, and down her right leg to the top of her ankle/ felt like her body was on fire (burning sensation) and could hardly walk or move and could barley do her pt exercises (gait disturbance) 2 days following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  On 19-SEP-2021 the patient developed a non-serious shingles on her face/ shingles spreading to her eye (herpes zoster), runny nose (rhinorrhoea), cough and 10 pustules on her forehead and they are crusting over (pustule) 6 days following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was reported "She went to her regularly scheduled physical therapy appointment (she is post-knee surgery)."  Laboratory details were not reported.  An anti-viral oral medication and eye drops was received for the events (herpes zoster) as a treatment.  It was not reported if the patient received a corrective treatment for the events (Pain, burning sensation, back pain and pain in extremity, rhinorrhoea, cough, pustule, inflammation and gait disturbance).   On an unknown date, the patient recovered from rhinorrhoea.  At the time of this report, outcome of the event cough was not recovered.  The event outcome was unknown for the other events.  There will be no information available on the batch number for this case.
From telephone contact received on 3/26/00, it was reported by a person who claims to be an RN who resides with the pt, that a dose of tetanus toxoid was administered on 2/19/02. On 2/20/02, the pt developed a large local reaction of redness, swelling and inflammation. Physician treated as a site infection with what she called Dicloxacillin 2GM's per day for 2 weeks. Over the course of several days, the pt experienced chest heaviness, headaches, unsteady gait, numbness in hands and feet and decreased sensation from her knees to her feet. Pt was taken to the ER, 6 times. Lab work of undisclosed nature, EKG, and  basic neurological exams were conducted. No neurological consult. Symptoms persist with etiology to be determined.
Per telephone client c/o reaction to PCV (rt ) arm. Fever, headache, nausea, a lot pain (rt) arm and discomfort throat/trachea area. Breathing without problems. Called from urgent clinic being seen now 5/29/15 at 1:10 p.m.
Pain in abdomen area has spread some to back; Tired; Stiffness; Pain in abdomen area; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness), ABDOMINAL PAIN (Pain in abdomen area), BACK PAIN (Pain in abdomen area has spread some to back) and FATIGUE (Tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness), ABDOMINAL PAIN (Pain in abdomen area) and FATIGUE (Tired). On 01-Mar-2021, the patient experienced BACK PAIN (Pain in abdomen area has spread some to back). On 18-Feb-2021, FATIGUE (Tired) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness), ABDOMINAL PAIN (Pain in abdomen area) and BACK PAIN (Pain in abdomen area has spread some to back) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2021, X-ray: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow-up received on 22 Jun 2021. Contact information updated. Lab information updated.
Arm tingling/tingling is going down to her hand; Arm soreness/pain and soreness in injected arm/lot of pain in the left arm; Swollen arm; This is a spontaneous report received from contactable reporter (nurse) from medical information team for a Pfizer sponsored program. The reporter is the patient. Other Case identifier: US-PFIZER INC-2021364320 (Pfizer).  A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 27Mar2021 14:30 (Lot number: 5R8734) at the age of 58 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Blood pressure high" (ongoing), notes: Diagnosed at age 34; takes Nifidene 30mg everyday; "High cholesterol" (ongoing), notes: Diagnosed at age 34; takes Simvastatin 20mg once per day by mouth; "Back pain" (unspecified if ongoing). Concomitant medications included: SIMVASTATIN taken for blood cholesterol increased (ongoing); NIFEDINE taken for blood pressure high; ALEVE taken for back pain; NAPROXEN. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 27Mar2021, outcome "recovering", described as "Arm soreness/pain and soreness in injected arm/lot of pain in the left arm"; PERIPHERAL SWELLING (non-serious) with onset 27Mar2021, outcome "recovering", described as "Swollen arm"; PARAESTHESIA (non-serious) with onset 02Apr2021, outcome "recovering", described as "Arm tingling/tingling is going down to her hand". Therapeutic measures were not taken as a result of pain in extremity, paraesthesia.  Additional information: She was scheduled to have the 2nd dose of the vaccine on 24Apr2021. No additional vaccines administered on same date of the Pfizer Suspect. The events did not require a visit to ER or MD office. No prior Vaccinations (within 4 weeks). No family medical history relevant to the events and no relevant tests.  No follow-up attempts are possible. No further information is expected.
Immediately upon the injection  I felt the cold going down my arm and then it was burning like on fire. That last intensely for several hours. Within minutes of the injection I had a migraine headache, pain in my calf that was like an intense charlie horse (this lasted into the next evening then over a day was much less), and I had extreme pain in my breasts. That pain lasted about 3 days.
As a prophylactic measure after my reaction to the 1st dose. I took 50mg of IM Benadryl prior to receiving the vaccine. . My vaccine appointment was for 9:40AM. I waited 30min at the vaccine site and felt ok so I went home. Got home around 10:30 and laid down. Felt drowsy because of the Benadryl. I woke up around noon feeling my lips "buzzing" and my tongue numb. Called my PCP who sent a RX for another IM Benadryl 50mg. I was able to take it around 3:30PM and that made the feeling on my tongue and lips go away. Around 9PM I started feeling chills, general malaise. And it went on through the night. Next day I felt really fatigued and slept most of the day. I went to work that night and it was a struggle. Took a Tylenol during my shift and next day once again slept throughout the day. At night I was feeling much better.
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. No concurrent conditions, medical history and concomitant medications were reported. On 02-SEP-2014 the patient was vaccinated with first dose of GARDASIL, second dose on 10-NOV-2014 and third dose on 13-JAN-2015 (inappropriate schedule of drug administration) (lot number, expiration date, dose and route of administration was not reported for all). No symptoms reported. No PQC (product quality complaint) filed. Additional information has been requested.
patient received first dose of Shingrix  in 2019 and never received the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (the patient received 1st dose of shingrix in 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient received first dose of Shingrix  in 2019 and never received the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date- 13-APR-2023 The pharmacist reported that patient received first dose of Shingrix series in 2019 and never received the second dose.  The reporter was consented to fallow up Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
One hour S/P HIB given, had angioedema of extremity that vaccine was given on right thigh to ankle.  Swelling, redness, tender lasting 1/2 hour, then resolving on own.
4/15/22  I had shortness of breath. I had a positive COVID test.  I went to the emergency room on 4/17/22. I had lab work, chest x-ray and a positive COVID test.  I was given steroids and albuterol. On 4/24/22 I had to go back to the Emergency Room . I was sick until the end of May. The only symptoms I ever had was shortness of breath and fatigue.  I also had some mild GI symptoms.