chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Stiff neck, can't move neck; This case was reported by a pharmacist via call center representative and described the occurrence of stiff neck in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 73PP9, expiry date 30th May 2024) for prophylaxis.   On 30th January 2023, the patient received Shingrix. On 31st January 2023, 1 days after receiving Shingrix, the patient experienced stiff neck. On an unknown date, the outcome of the stiff neck was unknown.   It was unknown if the reporter considered the stiff neck to be related to Shingrix.     Additional Information: GSK Receipt date: 31-Jan-2023. Reporter's Comment: The reporter stated that the patient could not move her neck. The reporter consented to follow-up via email.
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On an unknown date the patient was vaccinated with improperly stored VARIVAX (dosing details were not reported) (lot # N026071, expiry date: 20-SEP-2019) for prophylaxis which was reconstituted with sterile diluent (product storage error). The vaccine was stored at a temperature of -9 degree centigrade to 8 degree centigrade (5.8 degree centigrade) for a time frame of 42 hours. No previous temperature excursions reported. There was a digital data logger involved. No product quality complaint involved.
It started that evening with chills, headache, and shaking. I had a 101.6 fever. I had nausea. On Wednesday, I had diarrhea and fatigue. These symptoms lasted for about 5 days. I went to see the doctor to make sure that there was nothing was wrong. She gave me medicine for the diarrhea. Then, I got swollen lymph nodes in my groin area. When I went to the doctor, I did feel like something was in my throat. Now it in 2 weeks, I still have period of nausea. The lymph nodes have gone down.
Family reported infant has had uncontrollable crying past 2 hours, a change for this infant. No swelling, no redness, child's temp 97.7, able to sleep while here at clinic now at health dept.
Patient stated his right arm was bruised below the injection site and sore.  Patient states that it is less sore now.
I received my 2020/2021 flu vaccine while at work on the night of 11/18/2020 at 9pm. Immediately upon receiving the vaccine, I experienced flushing/hot feeling in my face & neck & had severe abdominal pain. I left work at 10pm and went right to bed since I was feeling ill. At 3am, I awoke from the severe abdominal pain I was still experiencing. I went to my kitchen & passed out on my hard wood floor. I awoke in extreme vertigo with nausea & vomiting. After about 2 hrs, my husband called an ambulance because I was unable to lift my head up and I was still experiencing severe vertigo with nausea/vomiting. I was transported to the hospital and treated in the ER (X-ray, basic blood work, etc.) I was admitted for 23 hr observation. I had an MRI and was started on Meclizine 25mg oral three times a day. I was evaluated by neurology during my admission. Upon discharge, I went to my PCP because I was still in vertigo. He referred me to a vestibular PT for treatment to reset my ear crystals. I was treated three times by the vestibular physical therapist. My vertigo resolved after 3 weeks. I was unable to work for 3 weeks. It was believed that I experienced a concussion from my fall.
On 4/12/01, mother reports that the child received 3rd Hep-B shot on 4/10/01. On 4/10/01, she states at about 19:30 or 19:45 at bedtime she noted hoarseness, some wheezing and a bark-like cough that produced some phlegm. The mother checked the child at night and noticed her breathing was not quite right. On 4/11/01, her breathing was better and cough was not as bark-like but continues as well as the productive phlegm. The mother was not able to see color of phlegm as the child swallows it. On 4/12/01, mother noted red/swollen/hardness in area that shot was given. She reports the redness extends from the top of her shoulder to shirts sleeve on arm and hardness is the size of a tennis ball in the area where short was given. Assessed by MD on 4/12/01.
At 4am I woke up and could not breath, it felt like my heart had stopped and it took about 30 minutes to catch my breath. When I got out of bed to catch my breath, I had no strength and fell to my knees, and had to crouch over on my couch I think I regained my strength as well as my breath. I couldn?t feel my left arm for about 1hr, but within 12 hours I regained feeling in it, but it still felt funny.  I went to my dr that morning, and have scheduled to go to see a cardiologist later this month. I saw my dr again today and she thinks it could be Cardiac Inflammation. I have stopped taking my Gabapentin since the incident occurred, and my dr and I are awaiting to see the cardiologist for further treatment.
Itchy, and heart racing turned over care to AMR was given oral Benadryl transported to hospital.
Right big toe appears blue/purple under toenail. Intermittent. Ultrasound by vein specialist reveals no blockage.
arm pain that has been with her since that injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 95-year-old female patient received BNT162b2 (BNT162B2), on 01Jun2022 as dose 2, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 01Jun2022, outcome "unknown", described as "arm pain that has been with her since that injection". Additional information: the patient received 2nd dose of primary series on 01Jun2022. She was complaining of arm pain that has been with her since that injection. She would like to know if this is normal and expected for this pain to be there this long after. Caller thought it was "peculiar" when she received the shot and the person who gave the shot. Caller noted that her arm had bothered since getting shot. The vaccine was given "between elbow and shoulder." It was reported "When I felt it it felt like she had stuck it down too far, because I felt it. The others I did not feel. She was acting peculiar. when she put the needle in the container and she picked it up with her 2 fingers and dropped it." After a Second Shot or a Booster Shot Side effects after the second shot may be more intense than the ones experienced after the first shot. These side effects are normal signs that the body is building protection and should go away within a few days.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Myalgia chills, fatigue, syncope vs seizure 43 yo employee falt fatigue on 12/24 and again on 12/25/20. The patients husband reports she was walking down the stairs, seemed "off" and missed the step/slid on step injuring both feet/ankles. Pt got up and was able to stand for a few minutes. Husband reports that he than sat her on the steps-few minutes later she had syncope with convulsions vs seizure. Per his report this lasted over a minute, she stopped breathing and was unresponsive. He reports she was confused while he was on the phone with 911 operator (3 minutes). Patient was taken to Health Center for work up. The head CT, labs, X-rays, EKG were unremarkable. Followed up her physician Dr. and was referred to neurologist. She had a MRI without contrast which was unremarkable and is scheduled to undergo a sleep deprived EEG. She is undergoing physical therapy at this time for injury to bilateral feet/ankles.
HYPER ACTIVITY, hives around mouth, itchy body, hicups, loss of appetite,  fever, sore arm.
He was vaccinated Feb 23 2017 he had a fever that night then on Feb 24 rashes appeared on his face and neck and still has fever. Today Feb 25 rashes spreads and he still has fever.
Hot to touch - red in area Friday afternoon - 28th October. BENADRYL - took pics. Still that way 10-31-16.
Swelling @ injection site, knot @ injection site, itching @ injection site, Rash on chest, neck, back. Reported to healthcare provider on 8/23/2021
p/vax pt devel an inj site rxn characterized by swelling & ecchymosis & was seen by MD on 4/23/99;
Patient began feeling extremely thirsty shortly after receiving vaccine.  She stopped several times on her drive home to get bottles of water because she was so thirsty.   She then vomited up the water.  Symptoms resolved after several hours.
Patient received Janssen immunization on 11/26/2021 at 6:20 pm. About a minute or so after receiving the shot, the patient had an adverse reaction to the vaccine. Gave the vaccine, walked out of the immunization booth to print a scan tag, then returned to the booth with the scan tag. Upon entering immunization booth patient appeared slumped in chair with head back and eyes open, but unfocused. Patient was moving erratically around in chair. Called out to patient and patient did not respond. Came up to patient, touched shoulder, and patient still did not respond. Patient screamed out and seemed to be in a panicked state. Touched shoulder again and said patient's name and patient turned to look and her eyes became more focused. Patient seemed to slowly calm down after that. Patient claimed to be dizzy and lightheaded after that. Patient described the event that she could feel the vaccine moving through her body. Patient stated that she felt like she was in her head screaming and then she was seen. Patient seemed confused about what happened after the incident and breathing was labored/erratic. Patient cried and comforted patient for about 10-15 minutes after incident.
Symptom onset 4/12, hospital admission date 4/19, died 4/25. Primary cause of death COVID-19, underlying causes sepsis secondary to COVID-19, hepatic encephalopathy, liver cirrhosis
I am experiencing in my right hand and arm, muscle weakness and pain. It's difficult to grab something and drive. I have to make sure I am holding the steering wheel with both hands left and right. I am going to the doctor on Friday, November 3rd.
Area of erythema and induration on R arm 30x30mm L arm 9x10mm.
Fever of 103.0 - treated w/ ADVIL and TYLENOL. Redness at injection site - size of a dime.
Within days developed shingles. Has had five episodes of shingles since getting vaccinated. No prior history of shingles.
Complaints of feeling dizzy/light headed, scratchy throat, chest tightness and a rash on her neck.  Pulse ox on RA 99%.    Facility Nurse sat with her for 1.5 hours and then she returned to work.  Was seen by doctor but not an official office visit.
Patient complaint of rash,hives,difficulty breathing and swallowing, wheezing, throat tightness, hoarseness, itching and feeling light headed less than 10 minutes after receiving the vaccine. Patient received Benadryl 50mg IVP, Pepcid 20mg IVP, 0.3mg epi IM. EMS arrived and transported patient to ED. In ED, patient received second dose of 0.3mg epi IM. Patient monitored in ED for approximately 4 hours. Epi drip started and plan to admit patient for observation.
Rash on entire body.  Patient had recently changed fabric softeners, so rash could have been related to this.
Wide area surrounding inj site with redness and edema. Shoulder/upper arm very painful several hours after inj. Symptoms improved some day #2, still with redness and warm to touch.
Patient reports consistent nerve pain at injection site that shoots down the arm that began during injection and has continued. She reports and Emergency room visit as well as difficulty sleeping due to arm pain.
Dizziness; nausea; headache; abdominal pain; body aches; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: BEL-3246), intramuscular in left arm on 10Jan2021 11:00 at SINGLE DOSE for COVID-19 immunization. Medical history included allergies to blue dye from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took Versed, Parafon Forte and experienced allergies. On 10Jan2021 11:30 AM, the patient experienced dizziness, nausea, headache almost immediately followed by abdominal pain and body aches within 6 hours. No treatment given for the events. The patient recovered from the events on unspecified date. The patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient has been tested for COVID-19.
Left side numbness of face including cheek, lips forehead and chin area all on left side of face
Blood (redness) in both eyes.  01/27/09 Received hospital medical records of 12/19-12/20/2006. FINAL DX: evaluation for nonaccidental trauma Records reveal patient experienced bilateral subconjunctival hemorrhages & cheek abrasion.  Twin sibling expired due to severe brain injury by nonaccidental trauma. Genetics, surgery, ortho & ophtho consult done.  Patient was transferred to hospital closer to home.  CPS & DSS evaluated & placed in foster care.  2/3/09 Received hospital medical records of 12/20-12/22/2006. FINAL DX: Non-accidental trauma Records reveal patient admitted while awaiting placement by DSS.  No new information.
fever of 102 degrees; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 102 degrees) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Spinal muscular atrophy. Concomitant products included RISDIPLAM (EVRYSDI) for an unknown indication.   On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced PYREXIA (fever of 102 degrees). On 03-Apr-2021, PYREXIA (fever of 102 degrees) had resolved.            Treatment information were not provided.Action taken with mRNA-1273 in response to the events was not applicable.
hurt all over; This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was recovered/resolved.   It was unknown if the reporter considered the general body pain to be related to Shingles vaccine.     Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingles vaccine and it hurt him/her all over for about 12 hours. Well worth not getting Shingles. The follow-up would not possible as no contact details were available. For tolerance to the 2nd dose of Shingles vaccine, refer case US2022AMR046835.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR046835:Same patient, 2nd dose
Breakthrough COVID-19 infection. Experienced chest pain and shortness of breath on 4/23/22. New cough noted 4/25/22. Fever 4/26/22. Positive COVID test 4/26/22.
Rash began approx. 24hrs after receiving Moderna booster vaccine. She denies pain or burning but reports some itching. It began on her abdomen and has now progressed across her torso and limbs.  The rash is a purpura.
Patient did not receive second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient did not receive second dose) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (needed to be hospitalized) in March 2020.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient did not receive second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient did not receive second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided. It was reported that patient had never got the second dose because patient's doctor tested him for antibodies and he was full.
swelled, hard 2" area, hot, itchy @ deltoid lasted 4 days;(local reaction);no treatment;
Extensive swelling and erythema from elbow to shoulder on right arm. saw doctor on 3/28/02. Gave Decandom and cream for arm.
PAIN BETWEEN FLANK AND SPINE (AREA OF LEFT KIDNEY); PAIN BETWEEN FLANK AND SPINE; UNABLE TO STAND; UNABLE TO BEND; 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: Unknown) dose was not reported, administered on 11-MAR-2021 09:45 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the subject experienced pain between flank and spine (area of left kidney). On 12-MAR-2021, the subject experienced pain between flank and spine. On 12-MAR-2021, the subject experienced unable to stand. On 12-MAR-2021, the subject experienced unable to bend. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain between flank and spine (area of left kidney), pain between flank and spine, unable to stand and unable to bend was not reported. This report was non-serious.
not feeling well; headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well) and HEADACHE (headache) 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 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (not feeling well) and HEADACHE (headache). At the time of the report, MALAISE (not feeling well) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.  Upon internal review on 21-May-2021, the age was corrected to unknown.   This case was linked to MOD21-085138, MOD21-085156, MOD21-14927, MOD21-041180, MOD21-041987 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: Patient denied to give contact information and consent to follow up was not given.; Sender's Comments:  MOD21-085138:follow up - contact information updated MOD21-085156:cross linked id MOD21-14927:cross linked id MOD21-041180:cross linked id MOD21-041987:cross linked id
Narrative:  05/03 Pt's wife reports pt is very sleepy, tired, low energy, SOB most of the time, no appetite, "head not right," dragging, slow on things, severe dry coughing x 2 weeks, wakes up every night due to cough 05/05 Seen by PCP, referred to ED due to looking volume depleted and continued c/o as above, admitted with covid pneumonia, hypoxemia 05/10 discharged from hospital, received remdesivir x 5 days, discharged on steroids and supplemental oxygen
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were possibly vaccinated with improperly stored doses of ZOSTAVAX lot # L024999, expiration date 06-OCT-2016 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced a temperature excursion of 6 degrees Fahrenheit for 48 hours. Data logger was involved. This is one of two reports received from the same reporter. Additional information has been requested.
This literature marketed report has been received from the authors of a published literature article, and refers to a 13-year-old patient of unknown gender. The patient's concurrent condition included combined immunodeficiency CID (unknown genetics), reported as inherited immunodeficiency and cutaneous granuloma. The patient's medical history and concomitant medications were not reported. On unknown dates at age of 5 and 9, the patient was vaccinated with M-M-R II (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient developed immunodeficiency-related vaccine-derived rubella virus (iVDRV). The patient had skin involvement that was described as initially psoriasiform or resembling pyoderma gangrenosum. The patient had chronic inflammation in skin, liver where rubella was detected by immunofluorescence or polymerase chain reaction (PCR). The Rubella capsid was detected and the iVDRV strain with multiple non-overlapping mutations was identified in the skin biopsy by sequencing viral genomes. The patient's CD3 count was 453 cells/uL, CD4 count 189 cells/uL, CD19 count 312 cells/uL and natural killer (NK) cell count 105 cells/uL. The authors assessed CD3 and CD4 count as low, and NK count as normal. The cutaneous granulomas spread relentlessly and led to amputation of a finger in an effort to control the spread. The surgical control of the lesion was unsuccessful. The patient was treated with linezolid, clarithromycin, rifampin, isoniazid, ethambutal, voriconazole, posaconazole, interferon and intravenous immunoglobulin (IVIG) without improvement. Nitazoxanide was used for 5 months without clinical improvement although rubella became undetectable by immunohistochemistry. The patient may have stabilized with diminished rubella capsid detection, but this patient died on an unknown date from progressive multifocal leukoencephalopathy (PML). The authors considered the iVDRV to be related to M-M-R II. Upon internal review, the iVDRV was determined to be medically significant as the patient underwent surgical amputation of finger. This is one of seven reports derived from the same literature article (linked # 1902USA004783, 1902USA004784, 1902USA004785, 1902USA003143, 1902USA004787, 1902USA004788). Sender's Comments: US-009507513-1902USA003143.
pt recv vax 20FEB96 & 4OCT96 pt devel shingles;pt was much improved by 11OCT96;
ACUTE PERICARDITIS WITH EFFUSION diagnosed 7/2/2021.  700 ml serosanguineous fluid extracted. Hospitalized 2d and discharged with newly found atrial fibrillation.  Discharged on Pradaxa.
Erythematous, macular rash, itchy and warm. Tx: Augmentin and Benadryl.