chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Actual time of onset unknown. Per hospital H&P: pt was in usual state of health until 9/4/15 when she recived the wrong dose of the meningococcal vaccine and was called back to providers office for correct immunization, with the second shot she felt pressure going into her chest radiating from her arm the next morning she felt neck fully arching and felt like someone was pressing down on her chest and her arms were throbbing, she felt paralyzed from neck numbness and lots of full body pain this lasted 3-4 hours, pt then went via EMS to hospital in where she had a 10 day stay from 9/5-9/15 where her symptoms included sensitivity to touch, headache, throbbing at the back of the head. She had sensitivity to light for 5 days. She had tremors and random jerking. On the second day of admit she fell in the bathroom. On day 6 of admission she had head jurking with eye movements. She was discharged from hospital and admitted to a medical center in where she is now. Pt was admitted 9/16/15 with similar symptoms. Pt has had additional work up including and EEG which was noted on the report to be normal. It is recommeded that you obtain medical records from both hospitals.
Patient experienced dizziness, palpitations, chills, myalgia, flu like symptoms.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age.  No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 13-NOV-2012, the patient was inoculated with ZOSTAVAX by a pharmacist as recommended for routine adult health maintenance and for the long-term prevention of shingles (dose, route, and lot # not provided). On or about 28-DEC-2012, the patient was inoculated the second time with ZOSTAVAX by a pharmacist as recommended for routine adult health maintenance and for the long-term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 18-NOV-2012, the patient was treated by a physician for the onset of a vesicular rash, which was diagnosed as herpes zoster or shingles. The patient was prescribed Acyclovir for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Tachypnea Panic Narrative:  Employee experienced panic response w/tachycardia up to 105 BPM. BP stable 144-147/84-90 throughout response. Benadryl 50mg admin @1650. Code team arrived assessed employee and took to ED
Bells Palsy returned after recieving the Moderna COVID 19 vaccine; This spontaneous report  was received from a Physician who phoned the call center regarding a 66-year-old female patient who received the Moderna COVID-19 (mRNA-1273) Vaccine and experienced a return of Bell's Palsy.  The patient's medical history was reported as, "having Bell's Palsy this past summer and it resolved". Concomitant medications were not reported.   On 25JAN2021, prior to the onset of the symptoms, the patient received her first of two planned doses of Moderna COVID-19 (mRNA-1273) Vaccine intramuscularly (Lot number: not provided).   On 25JAN2021, the Physician reported, "I have a patient who had Bells Palsy this past summer and it resolved. The patient had her first Moderna COVID 19 vaccine today and the Bells Palsy returned. Physician is not sure which arm the patient received the Moderna Covid-19 Vaccine in. Physician provides consent to Safety to contact regarding Adverse Event follow up".  The action taken for Moderna COVID-19 Vaccine was not reported.  The outcome of the events, "Bells Palsy returned after receiving the Moderna COVID 19 Vaccine" was not reported.; Reporter'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.  The patient's medical history of having Bells Palsy this past summer (but it resolved) is a contributing factor. Further information has been requested.
EXTREME MUSCLE PAIN IN FRONT AND SIDE OF RIGHT LEG AND ACROSS THE BACK AT HIP LEVEL. HAD  24 PHYSICAL THERAPY AND CHIROPRACTIC  SESSIONS  PAIN HAS MOVED AWAY UP THE LEG BUT STILL PERSISTS IN THE RIGHT UPPER LEG
8/18 & 8/19 didn't feel well.  8/20:  red eye & spots on face near eye.  Opthamalogist saw him 8/27/12 & diagnosed shingles. Tx with Acyclovir and Advil. Severe headaches continue as of today - 9/18/12.
she had Pneumonia twice within the last 18 months; she had Pneumonia twice within the last 18 months; The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 25Oct2019, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer reported for herself.   A female patient of unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) at single dose for immunization on unknown date. relevant medical history and concomitant medications were not reported. The patient had Pneumonia twice within the last 18 months. the outcome of the event was unknown.   Information about batch number was not available and is going to be requested.
Sore arm, followed by fever, chills, nausea, body aches, lethargic for over 24 hours
Redness, swelling, warmth to right upper arm x2 days. Atarax 1tsp tid, Keflex.
05/04/2021 I felt poorly that evening. I had shortness of breath and a mild cough, but I wasn?t sure if anything was happening. I also had sort of an electric shock pain down my left arm into my finger.   On 5/7/2022 there was no doubt.  I had a worsening with my breathing, I would get short of breath walking from the couch to the bathroom.  I had tried to go for my normal walk, and I was unable to breathe, I could not walk. That started a series of events that lasted weeks with trouble breathing.  I had an appointment with my doctor on May 12, virtual, then an in person visit on May 13. I had a chest x ray, a COVID test and was checked for shingles.  I had a mark on my finger that corresponded with the pain I had after my vaccination. A sample was taken even though it had been a while and it had started to resolve. It was negative for shingles, but since it had mostly cleared up, she was unable to get a good sample.  I had pulmonary function testing in September of 2021, because I had a history of multiple respiratory viruses.  The test indicated I did not have asthma. I ended up not getting answers and was not diagnosed.  I am not at 100% recovered now, but am not like I have been.  I plan to see an allergist next.
4 hrs p/vax pt had 10 second episode of arm/leg shaking w/eyes rolled back; sleepy for 10 minutes; exam in office 15 mins p/event w/no fever;
red rash at the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (red rash at the site of the injection) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 01-Feb-2021, the patient experienced VACCINATION SITE RASH (red rash at the site of the injection). At the time of the report, VACCINATION SITE RASH (red rash at the site of the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not provided.     Reporter did not allow further contact
This spontaneous report was received from a pharmacist via a company representative, concerning a male patient of unknown age. Medical history and concurrent conditions were not reported. On 08-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX, 1 DF (reported as single shot), therapy route reported as injection. Co-suspect and concomitant therapies were not reported. The pharmacist reported that on 08-OCT-2014, "immediately" after receiving ZOSTAVAX a patient had a fever, and a very red arm (erythema). At the time of the report the outcome was unknown. Patient was told to take TYLENOL as treatment. The patient did not seek medical attention or performed lab diagnostics tet. Additional information has been requested.
Client returned to clinic with redness and swelling at the injection site one month post vaccination. She report that the swelling began right after vaccination but has persisted and worsened. The site is tender and warm to the touch. The patient was referred to a provider to be evaluated.
Second shot more than 42 days/Patient never had second shot; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second shot more than 42 days/Patient never had second shot) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Prostate cancer, AFib and Coagulation defects, other and unspecified.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second shot more than 42 days/Patient never had second shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second shot more than 42 days/Patient never had second shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment details were provided.
Three hours after injection I fell fast asleep.  7 hours after injection I had mild body aches and chills that lasted about an  hour.  I have had a dull headache for about 15 hours.  I ended up sleeping for 14 hours
Called clinic to report that after receiving a tetanus diphtheria vaccine at noon on Monday 7/10/06, developed headache, lightheadedness, chills, fever 100.5 and generalized muscle aches the following Tuesday evening. States injection site left deltoid is mildly sore with no redness or swelling Tylenol or Ibuprofen PRN. I reported the above to Dr.
Patient appeared to lose consciousness  for a moment after exciting the consultation room where the vaccine was given ( about 2 mins after the vaccination). His dad was able to catch him before he fell completely to the ground.  We seated him and had him put his head forward.  I gave him a sip of water. He sat in our waiting area for about 10 more minutes.  He and his father said he was okay prior to leaving the facility. His sister commented to me that he may have a fear of needles.  I called the phone number given on the consent form about 2 hours after the incident to follow up to verify that patient had fully recovered. . I left a message and have not yet received a return call.
The patient was give his Pfizer booster on 11/17/2021 instead of 12/10/2021 when would be 6 months after his second dose. The patient has no adverse reactions.
Muscle pain; Headache; A spontaneous report was received from a healthcare professional concerning a 65-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events muscle pain, sporadic headaches.  The patient's medical history was Type 2 diabetes, high blood pressure, arthritis, chronic gastritis and diverticulitis. His Concomitant medications reported were Gabapentin 300mg for drug use for unknown indication.  On 29 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 011120A) via unknown route for prophylaxis of COVID-19 infection.  On 29 Jan 2021, the patient experienced the event(s) muscle pain, sporadic headaches and he took Tylenol and Advil to treat his symptoms.     Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), muscle pain, sporadic headaches was unknown.
Within 5 minutes of receiving injection, range of motion was limited to movement no greater than 6" away from the body in all directions. No strength in the left arm. No improvement in symptoms for 7 days. Couldn't sleep on left side, virtually zero functionality of the left arm. Treatment sought at same  clinic at the same day clinic - initial treatment was toradol injection (at day ~4 following vaccine), and it didn't work. Went back at day 7 (post-vaccine), and received an anesthetic and then steroid shot in the shoulder joint. Apparent improvement following introduction of steroids directly into the shoulder joint.
Pt developed cellulitis. There was redness. No fluctuation. Site was warm. Given Keflex 250mg/5ml 6ml PO q 6 hours x 1 wk.
Had an uterine ablation on 10/14/21.Had First dose Pfizer on 10/8/21.Had the ablation 10/14/21 and the second vaccine on 11/4/21. Pt had very  heavy bleeding/clotting  beginning on 11/14/21 -was seen by doctor on 11/17/21 and diagnosed with Menometrorrhagia and continues to have worse menstrual cycles than prior to uterine ablation.
24MAR94 soreness @ inject site; cont for 4 hrs following -localized inject site no burising, redness, or lump; 22APR94 seen by MD-exam WNL; xray-nl; given Naprosyn; slowly improved; stopped Naprosyn & pain slowly worsened;
VERY BAD DIARRHEA; UNABLE TO TO MOVE HER ARM; FELT COLD; BODY ACHES; CRAWLING SKIN SENSATION; SWEATING; FELT SICK; HEADACHE; SORE ARM; DIZZINESS; RED FACE; FLUSHING OF FACE; ITCHY FACE; DID NOT FEEL GREAT; BURNING PAIN IN UPPER LEFT ABDOMEN; NODE/SWELLING AT INJECTION SITE; This spontaneous report received from a patient concerned a 25 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included ehlers-danlos syndrome, and other pre-existing medical conditions included no breastfeeding.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 03-MAY-2021 17:00 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the subject experienced burning pain in upper left abdomen. On MAY-2021, the subject experienced node/swelling at injection site. On 03-MAY-2021, the subject experienced dizziness. On 03-MAY-2021, the subject experienced red face. On 03-MAY-2021, the subject experienced flushing of face. On 03-MAY-2021, the subject experienced itchy face. On 03-MAY-2021, the subject experienced did not feel great. On 03-MAY-2021, the subject experienced sore arm. On 04-MAY-2021, the subject experienced body aches. On 04-MAY-2021, the subject experienced crawling skin sensation. On 04-MAY-2021, the subject experienced sweating. On 04-MAY-2021, the subject experienced unable to to move her arm. On 04-MAY-2021, the subject experienced felt cold. On 04-MAY-2021, the subject experienced felt sick. On 04-MAY-2021, the subject experienced headache. Laboratory data included: Pain scale (NR: not provided) 4/10. On 05-MAY-2021, the subject experienced very bad diarrhea. Laboratory data included: Pain scale (NR: not provided) 6/10 (headache worsened). Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from red face, flushing of face, and itchy face on 03-MAY-2021, and crawling skin sensation on 05-MAY-2021, was recovering from unable to to move her arm, had not recovered from dizziness, sore arm, felt sick, body aches, headache, burning pain in upper left abdomen, very bad diarrhea, and node/swelling at injection site, and the outcome of sweating, felt cold and did not feel great was not reported. This report was non-serious. This case, from the same reporter is linked to 20210509350.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
This spontaneous report was received from a consumer (via a registered nurse) reporting on her daughter, a 2-year-old female patient. No information was provided regarding the patient's concurrent conditions, concomitant medications, drug reactions or allergies. On an unknown date in the past, the patient was vaccinated with VARIVAX (dose, frequency, lot number or expiration date were not reported), as chickenpox prevention. The vaccine was reconstituted with the Merck (MRK) sterile diluent (lot # and expiration date were not reported). On an unknown date in May 2017 (reported as "over the following weekend"), the patient developed a bumpy, pox-like rash on her body. The patient's mother stated that the rash might actually be mosquito bites, but she was not certain. She reported the event as potential transmission of VARIVAX virus from the patient's sister. The outcome of the events and the causality assessment between the events and therapy with VARIVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA004798: US-009507513-1705USA012785:
The same day as vax, the pt became febrile, limped and pointed to ears and chest. The temp increased to 103. The pt had a normal physical exam on 8/30 and 9/1.
Patient reports swollen lymph nodes in right armpit that developed 6 days after vaccination and remain swollen 5 days later. Patient denies any pain, reports swollen area is soft, and describes it as a sack of fluid.
Day after the injection, child delveloped large erythematous non indurated lesion on LL with ecchimosis of puncture site.
Worsened leg pain; Restless Leg Syndrome; Sleeplessness; Vaccine administration with an on going case of shingles; This case was reported by a consumer via call center representative and described the occurrence of leg pain in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles (was diagnosed with shingles in hospital) and leg pain (was hospitalized for leg pain).   On 13th January 2022, the patient received the 1st dose of Shingrix. On 13th January 2022, unknown after receiving Shingrix, the patient experienced off label use in unapproved indication. On an unknown date, the patient experienced leg pain, restless legs syndrome and sleeplessness. The patient was treated with gabapentin. On an unknown date, the outcome of the leg pain, restless legs syndrome and sleeplessness were not recovered/not resolved and the outcome of the off label use in unapproved indication was unknown.   It was unknown if the reporter considered the leg pain, restless legs syndrome and sleeplessness to be related to Shingrix.  Additional details were provided as follows: The patient was hospitalized for leg pain and was diagnosed with shingles. The patient stated that he was given a dose of Shingrix vaccine during this  hospitalization with an on going case of shingles, which led to off label use in unapproved indication. The patient stated that between 1 and 2 months, after receiving the vaccination, since his discharge from the hospital, the pain in his legs had worsened, and he had developed restless leg syndrome that caused sleeplessness. The patient was now taking Gabapentin as result. It was unknown if the MD was trying to treat shingles with the vaccine. The patient was given medical disclaimer and was provided information as per package insert content. The patient provided medical informer phone number for health care professional reference. Offered after call survey. The reporter consented to follow-up.
FELT CONFUSED; BODY WAS LIKE HEAVY; SLEEPY; CHILLS; HEADACHE; HIGH FEVER; MUSCLE ACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. As per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On APR-2021, the subject experienced felt confused. On APR-2021, the subject experienced body was like heavy. On APR-2021, the subject experienced sleepy. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced high fever. On APR-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt confused, body was like heavy, sleepy, chills, headache, high fever, and muscle ache on APR-2021. This report was non-serious.
Very dry scaly skin from vaccination site to other side, spreading over left breast. Plus, pain in both sides of neck and front of forehead. Funny feeling running down back to bottom of toes. Loss of balance and weakness.
Pt says that her arm is still sore from a Shingrix vaccine that was given on 11/18/18. She pointed to her deltoid, so there is no reason to believe that it was administered abnormally.
On 01/13/2021 at about 11pm I began having pain in both arms and across my chest. Also nausea and vomiting. At midnight I went to the Emergency room and was diagnosed with a heart attack, underwent emergency catheterization and stent placement. I had complete occlusion of the right coronary artery
This spontaneous report was received from a nurse practitioner and refers to a multiple patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, starting from 27-FEB-2017 the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # M039642 with an expiration date 03-JUL-2019 for prophylaxis (dose, route of administration and anatomical location were not reported). No adverse effects were reported. Administered doses of RECOMBIVAX HB experienced temperature excursion from 0 till 2 degrees Celsius for 1 hour and 26 minutes. There was no previous temperature excursion. The digital data logger was involved. Product quality complaint (PQC) was not reported.  this is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments:  US-009507513-1703USA005122: US-009507513-1703USA005123: US-009507513-1703USA001517.