chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt was hospitalized 1/12/06 for uncomplicated childbirth.  Prior to discharge on 1/14/06, she was given influenza vaccine, pneumococcal vaccine (due to h/o splenectomy), and Depo Provera.  It appears all vaccines were given in right buttock.  Later that day, she developed general malaise, then sweats and chills.  Her temperature that evening was 102.  She presented to the ED on 1/15/06 with fever (100.4), sweats, and chills.  Exam revealed an area of 8-10 cm expanding erythema with induration at her injection site on right buttock.  Given her history of splenectomy related to Hodgkin's lymphoma, she was admitted for IV antibiotic therapy (Rocephin, vancomycin, and clindamycin) for right buttock cellulitis.  She was discharged to home two days later.  MR received revealing a 2 night admission for c/o fever, chills, and sweats one day following Pneumovax and Flu vax.   Pt. noted that she had a fever the evening of her vaccines, and the following day presented to the ER per her obstetrician's instructions. She was noted to have an 8-10 cm area of expanding erythema and induration on the right buttock at the injection sites.  She was admitted for IV antibiotic therapy for right buttock cellulitis. She was discharged home. Assessment: Right buttock cellulitis.
Itching/Rash at injection site  for two weeks...reoccurring on left arm and on forehead...reoccurring on face...itching/rash..mostly in morning & evenings daily.
Blood clotting. I was pregnant the day I got the first vaccine, my due date was 5/27/22. The blood clotting caused a miscarriage on October 28th 2021.
Additional information received on 2/20/02 from a physician provided additional demographics and vaccination information. A physician reported that a 6 month old female received her third dose of Prevnar on 11/15/02. Concomitant vaccine therapy included ActHIB and Infanrix. On 1/25/03, at 8 months of age, she was hospitalized with a five day history of low grade fever, a two day history of painful left arm manipulation, and a one day history of left elbow swelling. On admission, she had a fever of 103.6 degrees F. An aspirate of the elbow joint was performed which yielded 4cc of pus. The child was treated with nafcillin. On 1/26/03, the aspirate culture grew Streptococcus pneumoniae and the antibiotic was changed to ceftriaxone. Upon receipt of the susceptibilities, the antibiotic therapy was changed to IV penicillin. The reporter indicated that isolates from the infection were taken for analysis; the results are pending. A diagnosis of Streptococcal pneumoniae septic arthritis of the elbow was made. An additional diagnosis of iron deficiency anemia was discovered during the course of this hospitalization. Laboratory studies were performed yielding the following results: WBC 14,100; neutrophils 57%; hemoglobin 9.5; and platelets 975,000. C-reactive protein tests were performed; the initial value was 9.1, peaking at 18.8, and less than 3 at discharge. Erythrocyte sedimentation rates were performed; the initial value was 14, peaking at 66, and 34 at discharge. Nuclear magnetic resonance imaging revealed possible bone involvement. A blood culture was performed; the result was negative. On 2/9/03, the child was discharged from the hospital. Discharge medications included high dose amoxicillin in order to complete the 28 days of antibiotic therapy. The reporter indicated that the child's condition is improving. Additional information received on 16Jan2004 from a physician provided laboratory results.
Information has been received from a physician concerning an 18 or 19 year old female who in March 2007, was vaccinated with a first dose of Gardasil IM.  In March 2007 the patient experienced nerve impact in her shoulder blade.  The patient went through physical therapy to repair the nerve damage.  The patient was unable to play softball because of the weakness and pain in her arm.  The patient could not fully use her arm.  At the time of reporting the patient was recovering.  The reporter considered the events to be disabling.  Additional information has been requested.
Patient had a sudden onset of pressure in her head four days later pt feeling vision closed it and darken. Pt lost consciousness & collapsed to the floor. Generalized jerking while unconscious.
Information has been received from a registered nurse concerning a 26 year old female with elevated liver enzymes in November 2006 and seasonal allergies who on 12-JAN-2007 was vaccinated with a first dose of Gardasil (lot # 655619/14207F) 0.5mL subcutaneous. Concomitant therapy included (CLARITIN-D). On 20-MAR-2007 the patient was vaccinated with a second dose of Gardasil (lot # unknown) 0.5mL subcutaneous IM. Medical attention was sought. On 19-JUL-2007 the diagnostic laboratory test showed elevated liver enzymes, AST and ALT, but this was down from the test in November 2006. At the time of reporting the patient's elevated liver enzymes, AST and ALT persisted. No additional information at this time. Additional information has been requested.
Headache, Myalgia, Fever & UrticariaPruritus Narrative:  Other Relevant History:
Scattered lesions distributed all over body; distinct and separate. Some are small macules, "some flea-bite like. Received MMR 12 days ago.
The patient is having a sharp, specific pain in her arm that gets worse when she raises her arm. Sometimes it even radiates up to her neck.
Fatigue; Felt something going through his system; Felt dizzy; Shaky; Felt warmth all over body; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt something going through his system), DIZZINESS (Felt dizzy), NERVOUSNESS (Shaky), FEELING HOT (Felt warmth all over body) and FATIGUE (Fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced FEELING ABNORMAL (Felt something going through his system). 17-Mar-2021, the patient experienced DIZZINESS (Felt dizzy), NERVOUSNESS (Shaky) and FEELING HOT (Felt warmth all over body). On 19-Mar-2021, the patient experienced FATIGUE (Fatigue). On 17-Mar-2021, FEELING ABNORMAL (Felt something going through his system), DIZZINESS (Felt dizzy), NERVOUSNESS (Shaky) and FEELING HOT (Felt warmth all over body) had resolved. At the time of the report, FATIGUE (Fatigue) had resolved.            The patient's medical history was not provided.  No relevant concomitant medications were reported. No treatment information was provided.
Almost a week after receiving the shot, my arm started itching and developed a whelp at the injection site on 9/10 at 11:00am. The whelp turned into a larger red blotchy spot by 9:00 pm on 9/10. The spot continued to grow on 9/11 and developed a darker red ring around the red blotchy spot around 2:30pm on 9/11. On 9/12, the spot began to fade and disappeared by end of day on 9/13.
Patient is here to follow-up on injection site reaction she had to Pneumovax 23.  She was given the immunization on October 13 in her left deltoid.  Patient states the area became red and swollen and tender within a few hours after getting the shot.  He states the following day she felt more tired and dizzy as well as a little lethargic.
My husband suffered with shingles for about four years had taken the shots/suspected vaccination failure; My husband suffered with shingles for about four years; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-MAY-2022 Reporter's Comment: This case was reported by patient's wife via interactive digital media. The patient had taken the shingles shots. The patient suffered with shingles for about four years. The patient's shingles was worst cases any doctor had ever seen. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Patient came in really anxious before receiving his vaccination and was really tense when attempting to receive his vaccine. After getting the patient to relax, the vaccine was able to be administered. However, patient then became pale, lethargic, and had ringing ears. The patient was sat down and given water while being observed. The pharmacist tried to check his heart rate but without success. EMS was then called for more advanced observation. Patient was recuperating while the EMS was on their way. EMS determined patient might have had an anxiety attack and cleared him after finishing their observations.
Pt wants to file a complaint regarding flu shot. Symptoms include: SOB, coughing up mucos, fever, chilly, loss of voice. Employee also wears heart monitor, which cannot differentiate SOB from flu shot vs. SOB related to cardiac issues. Has hx of asthma - which was exacerbated. Came to employee health on 10/12/16.
Medical Assistant (MA) was giving a meningococcal B vaccine in an adolescent's left arm. The MA inserted the needle and when the MA went to push the plunger in to inject the vaccine, the plunger wouldn't move. The MA took the needle out of the patient's arm and put the safety on. While the needle was out of the patient's arm the safety was on, the MA was able to move the plunger. The MA could still see the vaccine in the syringe. The MA explained to the patient what just happened and let the patient know they were going to waste that vaccine and get another one.
fever; 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 PYREXIA (fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. unknown and unknown) 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 PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown.            No concomitant medication was reported. The treatment information was not given.  Action taken with m-RNA-1273 in response to the event was not applicable.   Reporter did not allow further contact
This is a spontaneous report from a non-contactable physician via a Pfizer sales representative. A patient of unknown age and gender received on an unspecified date PREVNAR 13 at single dose and PNEUMOVAX, both for immunization. Medical history and concomitant medications were not reported. The physician mentioned that the patient had pneumonia symptoms that were consistent with pneumococcal pneumonia. The patient received both pneumococcal 13-val conj vac (dipht crm197 protein) and pneumococcal vaccine. Outcome was not reported. No follow-up attempts are possible. No further information is expected. Sender's Comments: Based on the information provided in the case, a lack of efficacy with PREVNAR 13 in this patient cannot be excluded. Further information like serotyping results is needed for a full medical assessment.
Severe 8-9/10 left arm pain, tenderness to palpation (around injection site), limited range of motion and stiffness, warmth lasting 5 days total. Arm pain and range of motion did not start improving until day 4. Improper vaccine administration - vaccine was injected too high, within the upper 1/3 of the arm.
Severe headache and fever over 105 for more than an hour now, but shivering uncontrollably
I had a little arm pain for about two days. I tested positive for COVID-19 on 02/12/2023. I contacted my doctor and got a prescription for PAXLOVID, but I did not take it. I figured I would let it run its course. I am feeling better without any lingering symptoms.
Allergic reaction - rash with itching on hands, arms, feet, midsection, neck; swollen eyelids; cough and wheezing breathing starting at 6:30 pm (3.5 hrs after vaccine shot) Took Benedryl at 7:15 - 7:30 pm Called on-call PCP hotline and directed to go to ER for treatment Visited ER at 8:00 pm - treated with Banophen, Pepsid (Famotidine) and steroid (Prednisone) via IV port
Patient reported that on 04/13 she had extremely joint pains... inside of arms hand and knees, Right hand is numb when she wakes up
pt recvd vax 30AUG94 & same day devel rxn @ Tetramune inj site-area became red, inflamed & warm to touch;also exp a high pitched cry;not seen by physician;pt recovered;parent informed MD of event @ child's 4mo well-baby visit
At approx. 2:30am I woke up to my entire body from the neck down tensing up, causing convulsions. I was fully cognizant of the event, I was able to move my body on my own. However, if I tried to remain still, various body parts would tense uncontrollably before releasing. This lasted for around 5 minutes and was becoming painful. I initially thought I was having a seizure. I have also noticed I've had a headache everyday since getting the booster which I rarely got prior. The injection cite is still red and swollen as of 01/18/2022.
I got my period even though I am on the IUD. I have not really had my period since getting my IUD.  Normally I would not report this. But I am worried that the Moderna vaccine may have impacted the efficacy of my birth control since I do not get my period on the IUD. Will take a pregnancy test at appropriate time to determine fully.  This must be researched as it has very frightening implications for unexpected pregnancy if it is impacting the IUD. Otherwise, my body was simply stressed enough by the vaccine that I have my period. It is odd either way.
Pt recvd DTP/OPV/HIB on13MAY92 & had reddened swollen thigh from inject site to knee on rt thigh; WBC drawn @ MD office & bone scan completed-neg scan;
pt recvd vax & had pain at inject site; red edema painful on LL; lymph node in neck enlarged, hot & painful 10mm; fever 99, aches: muscles & skin, felt sick,queasy,nausea;weakness;feverish; lasted 36 hrs;
Information has been received from a consumer concerning her granddaughter, a female patient who in 2008 was vaccinated with a first dose of GARDASIL (lot number, route and site not reported). Then the patient started experiencing nausea, fever and swelling (unspecified location). The patient developed rashes 3 to 4 weeks after the vaccination of GARDASIL. The patient went to see 2 physicians and was prescribed with BENADRYL, but her rashes were still there. At the time of report, the patient did not recover. No further information is available.
OCAS on 5-28-10 at 1716. Sx: High fever (102 degrees F), lethargy, no difficulty w/ breathing, emesis x2. Recommendation: Cold compress / Mom had no TYLENOL / fever not improve.
2 hours after moderna vaccine I started to feel pressure in my whole head and behind my eyes. Same symptoms I had 4 years ago with psuedo tumor cerebri. i had a massive flare up, dizzy, swollen lymph nodes. set my neurological system under attack with the head pressure.
Sore arm, fever 99.9, vomiting, headache, chills, skin feels like it's crawling, red arm and chest hurts.
HIVES OUTBREAK ON BODY, TREATMENT BENADRYL AND HYDROCORTISONE CREAM AND CETIRIZINE, OUTCOME PENDING.
Welt rose on left upper arm after receiving shot on Monday night. Felt tired on Tuesday and Wednesday.  Wednesday my temperature started creeping up through out the day. My temperature Wednesday morning was 96.6 at 1pm was 98.8 and at 8 pm was 101.7. Thursday was a lost day of fevers, sleep and chills. Sometime between Thursday night and Friday morning, my fever broke. My temp on Friday at 8 am was 98.8.
Patient fainted 5 minutes after injection for 5 seconds, vital sign b/p 83/52 respiration 20, pulse 55, O2 saturation 98% at first.  Second set of vital signs 112/72 pulse 47, respiration 20, b/p 112/72. Third set of vital signs b/p 104/64, pulse 52. Patient transferred to ER for one hour observation on stretcher. Patient reported it was not the first time she fainted after blood draw.
Patient is a 75 y.o. female who received the Moderna Covid-19 Vaccine, mRNA-1273 (PF) 100 mcg/0.5 mL IM Susp, Lot 020B21A on 4/1/2021. The patient experienced the following reaction(s) during the immediate   of observation: 1:40pm Patient vaccinated. Swelling and bruising noted to injection site. Patient was treated managed as follows:  1:43pm Ice pack provided and applied to left deltoid injection site. Patient denies other symptoms. VS BP 136/70, HR 63, RR 18, O2 sat 98% on room air. 2:00pm Swelling to injection site improved. Patient denies numbness or tingling. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. 2:01pm Patient escorted to exit.
Patient experienced difficulty breathing and throat tightness. Patient took 50mg of BENADRYL and within 30 minutes the symptoms had dissipated. Later that day temp 101.5.
SORE ARM; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received first dose of covid-19 vaccine ad26. cov2 (Dose number in series 1) (suspension for injection, route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total administered on an unspecified date for prophylactic vaccination. The patient had the only real side effect and had experienced from the original vaccine (Dose number in series 1) was some fatigue following vaccination with the first dose of covid-19 vaccine ad26. cov2 (Dose number in series 1). The outcome of fatigue was reported as recovered/resolved (Dose number in series 1).  The patient received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin was not reported, batch number: Unknown and expiry: Unknown ) dose was not reported, 1 total administered on 26-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced sore arm, and headache with the booster (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm and headache was not reported. This report was non-serious. This case, involving the same patient is linked to 20220613253 (Dose number in series 1).
Injection site reaction with symptoms including local irritation, redness, pain, and swelling. No known treatment and spontaneous resolution to the best of our knowledge. Reaction was delayed in onset, but for an unknown amount of time.
received 3rd dose of Pfizer vaccine, prior 2 doses received 12/17/21 and 1/6/21, no side effects Narrative:
fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of FATIGUE (fatigue) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis.    The patient's past medical history included No adverse event (no medical history reported).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) outcome was unknown.        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 and treatment medications were  provided .
Patient was unable to lift his arm. He said the area of the vaccination was hard and swollen.
Small fiber peripheral neuropathy, biopsy confirmed.  Symptoms began about 3 weeks after second dose of Moderna vaccine.  Started with tingling and burning pain in the right foot which then progressed up the right lower extremity.  Two months after the vaccination, it had spread to both upper extremities and by August 2021 it involved all four extremities.
This case was reported by a other health professional via call center representative and described the occurrence of autism in a female patient who received PEDIARIX. Previously administered products included Hepatitis B vaccine with an associated reaction of no adverse event (At birth). On an unknown date, the patient received PEDIARIX (unknown). On an unknown date, unknown after receiving PEDIARIX, the patient experienced autism (serious criteria GSK medically significant). On an unknown date, the outcome of the autism was not reported. It was unknown if the reporter considered the autism to be related to PEDIARIX. Additional information received: The daughter of the reporter's friend received a Hepatitis B vaccine at birth and then later received extra doses of Hepatitis B with PEDIARIX. The patient now has autism. The reporter also reported the case of her own son who experienced autism after vaccination with PEDIARIX. See case US2014011245.
Narrative:  COVID infection following COVID vaccine series 01/14, Pfizer, dose # 1 02/04, dose #2 08/11 COVID swab, result: detected 08/11 pt cc: cough productive, diarrhea, exposure: unknown
Member developed robust take due to smallpox vaccine.  Appear to have a breakout of deratitis around back of neck and uper shoulders. Appears to be improving