chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient completed a three-dose series of RECOMBIVAX HB with the third dose administered in February 2003. No other information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 22-FEB-2016, the patient was inadvertently vaccinated with a fourth dose of RECOMBIVAX HB injection, lot # L023387, expiration date 22-FEB-2016 (strength, dose and route of administration were not provided) instead of intended dose of VAQTA. No adverse effect was reported. No product confusion was reported. Additional information has been requested.
Left leg began hurting one hour after shot.  Throat started to swell causing increased clearing of throat,  swollen glands, with difficulty swallowing.  Throat, esophagus was swollen 5 hours later.  Went to emergency room and was given Benedryl, Epinephrine, Pepcid, and Solumedrol.  Kept in ER for 8 hours, Throat still swollen, but better, provided second doses of Benedryl and Epinephrine, then admitted for observation for 24 hours.   Throat and swallowing difficulties continued for approximately 3 days after discharge.   Hoarseness, difficulty swallowing, having to push liquids and food into diaphram was uncomfortable.
Moderna Covid-19 Vaccine EU A Sore arm /light headed /fatigue for about 2 days some light nausea
Patient could not move his legs at all, intermittently; he had moderate nasal congestion; a persistent cough; glassy eyes that he could barely open or not open at all, intermittently; patient complained of "pain all over" on Sunday night; patient would not or could not verbally respond to questions or commands on Sunday (26th) night; patient was intermittently speaking in gibberish and kept repeating the same words over again on Monday (27th).
C/O numbness in left arm (loss of sensation), c/o dizziness when standing
The resident noted slurring his speech and unable to answer her questions. Upon examination by the charge nurse and RN supervisor, the Resident showing stroke-like symptoms. The left side of the face is drooping, slurred speech, and unequal grips with L<R. 911 Notified of need for transfer, and family notified of CIC. The report called to ER.   Noted in patient records upon return. - Resident to ER  related to stroke-like symptoms and elevated blood pressure. Available records reviewed and indicate neurology consult via telemedicine. Ruled out for tPA related to time frame. CT head showed no evidence of acute intracranial process. Appears to have been treated in  ER. Given Rx for Levaquin 500mg po daily x5 days related to pneumonia, and discharged back to Village.  The resident reports that they were wanting to transfer him; however, he and his daughter declined the transfer. Indicates he stayed in ER. Reports that he feels fine today. Denies shortness of breath and phlegm production. Indicates an occasional cough. Denies pain.  History of C
Initial report was received from a health care professional on 07 October 2011. A 4 to 5 weeks pregnant female (age not reported) had received an ADACEL injection (lot number and site of administration not reported). The patient Medical History and Estimated Date of Delivery were not reported. Last Menstrual Period was reposted as 09 April 2011. The patient did not experience an adverse event. The outcome was not reported. Follow-up information was received from a healthcare professional on 16 April 2012. Based upon the new information provided, this case has been upgraded to serious. The reporter corrected the patient's first initial of her first name. The patient's Date of Last Menstrual Period was 04 September 2011 (previously reported as 09 April 2011). The reporter stated the patient terminated pregnancy. The patient's outcome was unknown. Documents held by sender: None.
No adverse event, it is a medication error.  Client received Pfizer as a 2nd dose instead of Moderna.
Redness, swelling, increasing size with 24 hours of vaccination.  Hot to touch.
After receiving vaccine, felt a bit lightheaded, nauseous. Felt with flu vaccine as well. Only coffee so far today; minimal water. VSS with BP 116/78, pulse 76. Drank water, ate saltines. Continued monitoring 15 minutes; felt better with nausea resolved, lightheadedness resolved. Encouraged to continue hydrating today; follow as needed if symptoms worsen.
Muscle ache at site of injection, low grade fever (100), fatigue, headache, chills, lack of appetite lasting three days.
passed out; feel faint; This is a spontaneous report from a non-contactable pharmacist. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient felt faint and passed out after receiving dose, pharmacist asking if need to re administer although received dose. The outcome of the events was unknown.  No follow-up attempts are possible. Information on lot/batch cannot be obtained. No further information is expected.
Dr said it was shingles; lower back had five hundred blisters; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced shingles and blisters. The patient was treated with medication unknown (Pill (Medication Unknown)). On an unknown date, the outcome of the shingles and blisters were recovered/resolved.   It was unknown if the reporter considered the shingles and blisters to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 17-AUG-2022.  Reporter's Comments:  This case was reported by patient via interactive digital media. The patient got the shot then about two weeks later his/her lower back had five hundred blisters. The patient went to the doctor, he said it was shingles. He gave patient a couple of shots and some pills and patient got over it in a couple of days. Additional Supportive Information: The follow up would not be possible as contact details were not provided.
This spontaneous report was received from a health care professional refers to unspecified number patients of unknown demographics. On an unknown date the patients were vaccinated with MMR II (lot # K016154; expiry date: 24-SEP-2016) (dose, route and frequency unspecified). Concomitant therapy was not reported. On an unknown date the patients were administered improperly stored vaccine. No adverse effects reported. The outcome of incorrect product storage was unknown. There was no product quality complaint involved. This is one of several reports received from the same source. Additional information has been requested.
Woke up in middle of the night very weak, staggering, unsteady on feet, trouble speaking.
CHILLS; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020,expiry: UNKNOWN) dose was not reported, administered in left arm on 28-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-MAR-2021, the subject experienced chills. On 28-MAR-2021, the subject experienced fatigue. On 28-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, and had not recovered from fatigue, and headache. This report was non-serious.
Severe body pain. Body chills Fever 102'-103 for 48 hours Sweats/after fever broke Injection site redness & swelling Knots on Deltoid muscle
Woke up Tuesday at 11PM crying with pain on the right side of my back.  After pain and crying for 2 hours fell asleep.  OK when I woke up.  Woke up Wed. at midnight crying with pain on the right side and mid area of back.  Fell asleep after 2 hours.  OK when I woke up.  Pain not as severe as Tuesday night.  Woke up Thursday at 11 pm with pain.  Not severe and was able to go back to sleep. Pain Tuesday night was an 8.  Pain Wed night was a 7. Pain Thursday night was a 3.
This spontaneous report was received from a physician referring to a 12 year old female patient. The patient had no concomitant medications, no pertinent medical history and no drug reactions/allergies. On 10-NOV-2016, the patient was vaccinated with a dose of GARDASIL 9 (lot # M030380, expired date on 01-FEB-2019, concentration, dose and frequency were unknown) intramuscularly as "standard" therapy. On 04-DEC-2016, the patient had panniculitis with tender swollen nodule at injection site. The patient was instructed to take non-steroidal anti-inflammatory medications for 3 weeks. There was no lab diagnostics studies performed. At the time of this report, the outcome of the event was unknown. Additional information has been requested.
Pt vaccinated w/DTP/OPV had continued irritable high pitched "screeching" crying lasting.
B lower extremity red dots that formed into palpable petechiae, also on extensor surfaces B UES.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider, a physician, recommended and or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about OCTOBER 2007, the patient was administered the ZOSTAVAX (lot number, dosage and route of administration not provided) (by an unspecified healthcare provider/professional). The patient was inoculated with the ZOSTAVAX to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 20-JUL-2008, the patient was treated by a physician and also by another physician (ophthalmologist) for shingles on the face, scalp, ear, and eye and other zoster related vision and eye injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (not further specified); lost wages; loss of earnings capacity; and other losses and damages as a result of shingles and other zoster-related injuries. The outcome of the events was considered to be not recovered. Upon internal review, the event of Shingles on eye and other zoster related vision and eye injuries was determined to be medically significant. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of hives in a 65-year-old female patient who received SHINGRIX. Concurrent medical conditions included arthritis. Concomitant products included naproxen, AVAPRO, FEMHRT and alprazolam. On 3rd January 2018 14:00, the patient received the 1st dose of SHINGRIX (intramuscular). On 13th February 2018, 41 days after receiving SHINGRIX, the patient experienced hives. The patient was treated with prednisone. On an unknown date, the outcome of the hives were recovered/resolved. The reporter considered the hives to be unrelated to SHINGRIX. Additional details were reported as follows: The patient developed hives that started around her eyes. The reporter states that the hives were absolutely not related to SHINGRIX. She was concerned that the prednisone would affect her response to SHINGRIX and also because she was going on vacation on 19th May 2018 and would be taking prednisone prior to leaving because of her arthritis. This was around the time she would receive the 2nd dose, so was concerned that prednisone would interfere with her 2nd dose as well. The patient has denied permission to contact their physician.
Tachycardia starting approx 12 hours after injection with resting heart rate between 100 and 120 bpm lasting approximately 18 hours
Pt broke out in hives, had difficulty breathing, after receiving the flulaval vaccine on 10/11/08
very sore arm at the injection site after both doses; Dr. told me that Aspirin was not stopped in the trials; This is a spontaneous report from a contactable physician, the patient. A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown for first and second doses) solution for injection intramuscular on an unknown dates (at the age of 67-years-old) as a single dose for COVID-19 vaccination. Medical history was not reported. Concomitant medications included acetylsalicylic acid (ASPIRIN) low dose and ongoing atorvastatin. The patient got a very sore arm at the injection site after both doses but no other side effects. The patient took low dose aspirin and atorvastatin and was concerned that the reason for the lack of side effects was that the medications may have blunted the vaccine immune response. A doctor told the me (patient) that aspirin was not stopped in the trials. The outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
SHINGRIX given 2-11-19. On 2-12-19 had chills, headache, dizziness and achiness. On 2-13-19 in the AM headache gone; had a non itchy pinpoint red flushed rash across upper abdomen and over arms, also had diarrhea x 4. On 2-13-19 midafternoon developed severe epigastric pain with diaphoresis. Treated at an ER. Treatment included lab, EKG, CXR, CT of abd and pelvis which were negative. A GI cocktail and IV SOLUMEDROL and PROTONIX were administered with some relief. Pt. continued to feel weak with no appetite and mild epigastric pain for approximately one week. He had an EGD on 2/22/19 which was negative. The ER Dr and his PCP both inst. pt. to not get 2nd dose of SHINGRIX.
EXCESSIVE SORE THROAT WHICH TURNED INTO LACK OF SLEEP. MAJOR CONGESTION, CAUGHING, SNEEZING AND MAINLY FATIGUE. WENT TO FACILITY AND WAS GIVEN AMOXACILAIN WHICH DID NOT DO ANYTHING. WENT TO GET A COVID TEST WHICH CAME OUT NEGIATIVE. MAJOR FATIGUE AND LIGHT HEADEDNESS. THIS LASTED 7 DAYS SO FAR
pt was sore & bruised & thurs got hard where vax was; Fri red areas 1/2 in to 1 in below 2 1/2 x 3 in area warm, red, raised; seen by MD;
Symptoms: n/v, dizziness and SOB at rest for the last 7 days, Treatment: Remdesivir, and Dexamethasone
TIGHTNESS IN CHEST; SHORTNESS OF BREATH; DIZZINESS; SEVERE DECREASE IN SEXUAL PERFORMANCE; LACK OF MORNING ERECTIONS; FATIGUE; This spontaneous report received from a patient concerned a male 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 was not reported, administered on AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On AUG-2021, the patient experienced tightness in chest. On AUG-2021, the patient experienced shortness of breath. On AUG-2021, the patient experienced dizziness. On AUG-2021, the patient experienced severe decrease in sexual performance. On AUG-2021, the patient experienced lack of morning erections. On AUG-2021, the patient experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, tightness in chest, shortness of breath, dizziness, severe decrease in sexual performance and lack of morning erections was not reported. This report was non-serious.
Pt developed Herpes Zoster about 3 weeks after the 2nd dose of his vaccine. Pt only informed me today when he came for his booster. Pt states he continues to have neuropathy in his hand since recovering from the shingles.
Initial health care professional report received on 09 Nov 2010: This patient with an unknown medical history was vaccinated with MENVEO (batch number: 100027) 0.5 ml on 03 Nov 2010. The patient inadvertently received only Men CWY liquid conjugate, instead of being reconstituted with Men A lyophilized powder conjugate component. No adverse event was reported following this administration error.
Cellulitis at injection site. Patient became disoriented and fell. Hospitalized for 5 days. Now rehab at nursing home.
intense headaches; tired for a couple of days; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 01Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID diagnosis", start date: Mar2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "intense headaches"; FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "tired for a couple of days". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax 19SEP96 & 23MAY97 pt devel a mild varicella that consisted of one lesion on forehead;
Tingling in throat after injection, but subsided after 5 minutes. About an hour after injection, I checked injection site and found a half-dollar bill sized red welt that was hot to the touch.
Patient was 17 when they received the 1st dose of the Moderna Covid-19 vaccine. No known adverse events occurred after vaccination. Patient did not receive their 2nd dose as of report date.
2 weeks post small pox pt had complaint of chest pain (sharp), off and on for approx 1 week. Pt history of heart surgery, pt was cleared by MD at field tent clinic.
Client was vaccinated in the left deltoid, without incident. Client was monitored for 15 minutes answer protocol, and no reaction was observed by RN, or reported by patient. Client reported no previous reaction/allergies. And no reaction with first Moderna vaccine was reported. 13:18 approximately 50 minutes later client was eating lunch with her coworkers and had complaints of redness and heat in her lower left arm. Client alert and orient X 4, no distress noted, RR even and unlabored, speaking in full sentences, non diaphoretic. 13:22 Client was administered 25 mg Benadryl by mouth, RR even and unlabored, no signs of acute distress. 13:42 Redness and heat resolving. 14:00 Small amount of redness and heat noted. 14:15: very small amount of redness noted, client has no complaints of pain and remains alert and oriented x 4, rr even and unlabored, speaking in full sentences, no signs acute distress. Explained to client to followup with pcp, and to utilize 911 system as needed.
Information has been received from a registered nurse referring to a 1 years old female patient. There was no pertinent medical history, concomitant drug or drug reaction/allergies of the patient. On 28-MAR-2016 the patient was vaccinated with a dose of M-M-R II (Lot# was reported as L0277432, expiration date was reported as 22-JUL-2017, dose and strength were not reported) subcutaneously. The patient had an unspecified rash on an unspecified area of her body for 3 days in 2016 which was getting worse. Her parents sought medical attention by contacting the office after the rash had appeared and the patient was then seen in the office on 08-APR-2016 where a physician stated the rash appeared to be a measles-like rash and gave the patient the diagnosis of measles. No treatment was given and no lab diagnostics studies were performed. Outcome of the event and the causality were not reported. It has been confirmed that lot# L0277432 was not valid for M-M-R II. This is one of the several reports from the same reporter. Additional information has been requested.
Expanding red raised rash at injection site that grew until I had an anaphylactic event. It is unknown if it is due to the vaccine due to it taking 3 days to happen but I strongly suspect it. Taken by ambulance to hospital and epinephrine.
redness 2 1/2 in x 3 1/2 in, warm to touch, tender to patient- right thigh. Treated with Keflex.
Extreme vomiting began about 12 hours after vaccine. Couldn?t even keep down a sip of water. Continued to have extreme vomiting/nausea for about 10 hours .  Also had a very bad headache. Was able to eat a very little bit of food about 10 hours after nausea started. Was very weak. It was the worst, most extreme vomiting I ever had
Fever on day of vaccination, tmax 102 Diarrhea following 2 days 2 days later whole body rash no swelling
The patient received his vaccine.  Within a minute he  started rubbing his neck.  I asked him if he was okay.  He stated he was, it was just his neck hurting. He  told me it's was going on for a long time and he is supposed to have surgery soon to correct the problem.  He began to lean forward.  I again asked if he was okay.  He said he was but when I asked him to sit up for me, his color was pale.  Myself and the patients wife accompanied him to the holding area where the EMT's were on standby.  The patient was able to walk.   02 applied at 8l/m per FM rebreather. A+)x2  Temp: 98.6  B/P 0/40  P:69 weak and thready,  Skin: pale; coool; clammy.  Respirations 20 shallow ;  The patient after about a minute or so with the O2 mask asked that the mask be removed.  He said he felt better without the  02.   Spo2= 97%  on RA.  The patient was transfered to the stretcher. The EMT's started an IV and placed the patient on a heart monitor. The patient was transfered to the ambulance for transfer. The patient became unresponsive for approximately 90 while en route to the hospital.
On 7/27 patient woke up with a mild headache that persisted for a few days along with some neck soreness. On 7/30 he woke up with ride facial paralysis and came into the ED. An LP was done. CSF came back normal. Enterovirus is negative, HSV and CMV are still pending. All other results were within normal limits (Chem 7, CBC). MRI was normal. Patient discharged with a likely diagnosis of Bells Palsy and given a prescription for a steroid and antiviral.
Started to feel nauseous and achy, felt that way for nearly 2 days. The following day felt like hear was fluttering, felt really hot and ears started ringing; felt like was going to pass out lasting 15-20 seconds.
A report received from a Physician concerns a, female patient. No information regarding the relevant history, concomitant disease and concomitant drug was provided. Patient received nasal FLUMIST QUADRIVALENT started on an unknown date. it was reported that patient was the mother of the child, the mother was administered the FLUMIST at the pediatrician's office. After leaving the office she noted throat swelling and went to the emergency room where she received BENADRYL which helped alleviate the reaction. FLUMIST QUADRIVALENT was continued. The outcome of throat swelling was unknown. The report was considered to be non-serious by company physician.