chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT REFERS THAT THE NIGHT AFTER VACCINATION SHE BEGAN EXPERIENCING A DEBILITATING BODY ACHE, RASH IN LEGS AND FACE, ARRHYTHMIAS, REDNESS IN FACE, TIREDNESS AND FLU LIKE SYMPTOMS LASTING FOR MORE THAN 5 DAYS. SHE WENT TO THE ER AND DR. TOLD HER SHE HAD A VIRUS AND ORDERED HER TO TAKE DOLOGESIC AND VIT. C.
Patient had a rash in May and June that his dr said was probably heat rash. It continued and appeared to get worse in June and July after the vaccination. It was just diagnosed as excema or a related skin condition by his doctor in late August.
Pain at site of injection with movement, joint stiffness in injected arm. Fever 101>102. Migraine. All symptoms lasted 48 hrs and subsequently subsided. I took 600mg of tylenol and 600mg of motrin to manage the fever as instructed by physician.
Pt came to pharmacy for  1st Shingrix in a series of two.  He went to the physician for a rash on bilateral ankles and bilateral inner arms and chest where they meet that he thought was chicken pox.  No other rash areas were notated. They were not oozing and were bright red. The actual Left Deltoid had no rash or redness, could not see the injection site.  The diagnosis code taken from the sheet the pt brought with him from his physician was:  T80.69x Serum sickness due to drug, avoid follow up vaccine.  Allergy to shingrix was marked as an allergy in the pharmacy record.
Fever. Fatigue. Fast heart beat. Weakness. Chills. Dizziness.
Frozen shoulder; Problem moving her arm behind her head; Neurological symptoms/Numbness in the face / Numbness in the arm; Pins and needles; Drooping; This spontaneous case was reported by a consumer and describes the occurrence of PERIARTHRITIS (Frozen shoulder), MOBILITY DECREASED (Problem moving her arm behind her head), HYPOAESTHESIA (Neurological symptoms/Numbness in the face / Numbness in the arm), PARAESTHESIA (Pins and needles) and DROOPING SHOULDER SYNDROME (Drooping) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 032B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, 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 experienced PERIARTHRITIS (Frozen shoulder), MOBILITY DECREASED (Problem moving her arm behind her head), HYPOAESTHESIA (Neurological symptoms/Numbness in the face / Numbness in the arm), PARAESTHESIA (Pins and needles) and DROOPING SHOULDER SYNDROME (Drooping). The patient was treated with ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) for Numbness, at an unspecified dose and frequency and STEROIDS for Frozen shoulder, at an unspecified dose and frequency. At the time of the report, PERIARTHRITIS (Frozen shoulder), MOBILITY DECREASED (Problem moving her arm behind her head), HYPOAESTHESIA (Neurological symptoms/Numbness in the face / Numbness in the arm), PARAESTHESIA (Pins and needles) and DROOPING SHOULDER SYNDROME (Drooping) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-311359.
I had strong stomach cramps for about four hours. This is something that I have not experienced in as long as I can remember. I had not ingested anything that would cause this condition. It eased up and eventually ended after I took several tablets of a generic form of Pepto-Bismal.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2013, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the 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 of herpes zoster. On or about 12-NOV-2015, the patient was treated for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of 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.
Info has been received from a  physician concerning a few children who in 2006, were vaccinated po with a 2.0 ml dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) at 4 months of age. Unspecified medical attention was sought. No further info is available.
shingles outbreak / after the complete vaccination/ suspected vaccination failure; shingles outbreak; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number ZG47A, expiry date 12th February 2021) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number B5EK2, expiry date 28th April 2020) for prophylaxis.   On 27th July 2018, the patient received the 2nd dose of Shingrix. On 1st May 2018, the patient received the 1st dose of Shingrix. On 4th August 2021, 1104 days after receiving Shingrix and 1191 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient had a shingles outbreak after the complete vaccination of Shingrix. The shingles outbreak was not confirmed by the pharmacist, the patient stated having shingles. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory test confirmation for shingles were unknown. No further events were reported at the time of the call. The pharmacist called to know if they had to revaccinate the patient or not. The health care professional could not clearly see the last letter of the lot number of the 2nd dose of Shingrix. The reporter consented to follow up by phone.
This case was reported by a physician and described the occurrence of lethargy in an 18-year-old male subject who was vaccinated with Boostrix plus a separate injection of Menomune for prophylaxis. The reporter is the mother of the subject. The subject's medical history included adenoidectomy, seizure disorder, tonsillectomy and tourette's syndrome. The subject had no adverse events following receipt of prior immunizations. Concurrent medications included Lexapro, Benadryl, Depakote ER, Abilify and Risperdal. On an unspecified date in May 2005, on or before 18 May 2005, the subject received unspecified dose of Boostrix administration. The subject was seen by a physician and the events resolved "within 24 to 48 hours."
Moderna-Covid -19 vaccine EUA  I started with scalp itching really bad, then swollen lymph nodes, the rash that spread over entire body and hoarseness in voice and moldy sore throat
23JUL92 recvd 1st dose of Engerix-B & around 24 hrs later devel low grade fever, flu-like sx, body aches & malaise;
On an unknown date, the patient reports developing shivering and rash, bump and warm at injection site.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), shivering, rash, bump, warm was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Immediately throat tingling (thought it was me being nervous) by an hour later started to get slight headache. By two hours I was losing my voice and exhausted, coughing, chills, dizziness. Jaw pain, throat lymph nodes swelling and painful to swallow, my knees and neck hurt to bend and move, weak and bilateral ear pain. Left work by 2pm and by the time I got home last night I was unable to breath well and extremely chilled with no voice and extreme headache. Took Benadryl and headache medicine and went to sleep. This morning voice still gone, jaw still tender to move, headache is slightly better, congestion, chest pain and cough, still weak, lymph nodes are no longer swollen. Neck and joints still painful to move.
I had a pain in the top of my spine and bottom of my neck. I went to the chiropractor first and she did several adjustments, which did not work.  I went to my doctor and she prescribed a anti spasm, which did not work.  I went back to the doctor and they prescribed a stronger dose.  That did not seem to work either.   I went back to the chiropractor and I have been going ever since.   I also had a x-ray done.
vial punctured for more than 12 hours/punctured vial left in the fridge; vial punctured for more than 12 hours/punctured vial left in the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (vial punctured for more than 12 hours/punctured vial left in the fridge) and EXPIRED PRODUCT ADMINISTERED (vial punctured for more than 12 hours/punctured vial left in the fridge) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, the patient experienced PRODUCT STORAGE ERROR (vial punctured for more than 12 hours/punctured vial left in the fridge) and EXPIRED PRODUCT ADMINISTERED (vial punctured for more than 12 hours/punctured vial left in the fridge). On 21-Sep-2021, PRODUCT STORAGE ERROR (vial punctured for more than 12 hours/punctured vial left in the fridge) and EXPIRED PRODUCT ADMINISTERED (vial punctured for more than 12 hours/punctured vial left in the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.  No treatment information was provided.  The pharmacist reported that the vial was punctured on Monday at 12 P.M, the vial was then left in fridge and the vial would have expired by 21-Sep-2021 at 12 A.M. The vaccine was then administered from the vial on 3.59 P.M, 4.53 P.M, 9.15 P.M and 9.16 P.M. The patient presented with no symptoms.
Systemic: Chest Tightness / Heaviness / Pain-Medium, Additional Details: Chest pain-felt like getting vaccine in chest area/breast last night (pinch/stabbing pain) and then changed to more of a dull pain today. pain scale 5 and now dropped to 3
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced pain in arm and injection site erythema. On an unknown date, the outcome of the pain in arm was unknown and the outcome of the injection site erythema was recovered/resolved. It was unknown if the reporter considered the pain in arm and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but could be 62 years or 63 years. In May 2018, on Tuesday, the patient received SHINGRIX on an unknown arm. The patient experienced some soreness in her arm after the injection. In 2018, on Saturday, 4 days after vaccination, the patient noticed 3 red spots on her arm by the injection site about the size of a 50 cent coin. The patient stated that the spots looked like she was going to get shingles, but they resolved after about 2 days.
1100 vaccine was given 1125: Patient feels headache, metal taste in her mouth. She feels some dizziness, vision feels blurred. She is breathing with her mouth open and feels out of sorts. After 15 minutes she had a "funny feeling in her throat" Transferred to the ED at 1140, first responder team was called
Chills, vomiting, worsening confusion. Patient had vomiting that began about 48 hours after vaccine dose. Had subsequent chills. No fever.  Evaluated by her primary care provider on 2/26 AM and the ER at Hospital on 2/26 PM.  Noted to have chills, nausea and vomiting in the ER. Also noted to have tachycardia, likely related to her atrial fibrillation. She had been unable to take her home medications due to vomiting and had missed her rate controlling medications. She was given IV Zofran and Tylenol with good control of her chills and vomiting.
2 days p/1st inject had gross hematuria to MD hospitalized x 4 days; cont hematuria & pain lt kidney;
Sudden low back pain; stiffness; This is a spontaneous report from a contactable consumer. The consumer reported similar events for two patients, this is the 2nd of 2 reports. A female patient of an unspecified age received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of the same vaccine for covid-19 immunization on an unspecified date. The patient experienced sudden low back pain and stiffness on an unspecified date a few hours after receiving her second vaccination. The outcome of the events was unknown.   No follow-up attempts are needed. Information on the lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021154727 same  drug/reporter, different patient/event
Information has been received from a pharmacist concerning a 10 year old female vaccinated with a first 0.5 ml dose of Gardasil (yeast). Two days later, the patient developed a rash behind her knees and on her chest. Unspecified medical attention was sought. At the time eof this report, the patient's outcome was unknown. No product quality was involved. Additional information has been requested.
pt was given the incorrect vaccine, she was to receive the Tdap vaccine and not HPV.
approx 2 1/2hr p/vax pt started shaking BP 144/90, HR 103;states just don't feel right;denies itching or resp diff;few min later whelps noted on neck, c/o feeling hot clammy & itching & feeling flushed;given DPH & pred;
Swelling and induration at injection site. Swelling extended down entire arm. Reported by pt at 8:52am. 8/25/18 Pt reports swelling is mostly resolved, 8/30/18.
post vaccination it was discovered pt received the monovalent pediatric vaccine NDC 80777-275-99 instead of the requested bivalent vaccine NDC 80777-0282-05
pt recv vax 20APR95 & 28APR95 pt devel a fever of 103;2 days later fever was 105 & stayed;would not walk;lab eval showed a neg monospot test, neg blood cult & urine;also exp inc SGOT, SGPT, LDH & triglycerides;had an off the wall CBC This is in follow-up to report (s) previously submitted on 5/30/1996. A nurse reported that a 1 year old male patient was vaccinated with MMR II vaccine on 20APR95 SC in the deltoid. Concomitant vaccinations that same day included haemophilus b conjugate vaccine IM in the left anterior thigh. On 28APR95 the patient developed a fever of 104 degrees F. Two days later, his fever was 105 degrees F. He was lethargic and "could not walk for five days". Laboratory evaluation showed a negative monospot test, negative blood cultures and urine. He also expereinced increased SGOT, SGPT, LDH and triglycerides. He had an "off the wall" CBC and abnormal blood chemistry. Lipoproteins were "very high". On approximately 01MAY95 he developed a rash that lasted for 13 days. He presented to an emergency room for treatment. Approximately 14 days later, the patient recovered. It was reported that 2 other patients had a similar experience following vaccination with MMR II (WAES 97050595 and 97120033). No further information provided.
Patient fainted. Medical Provider and RN immediately responded. Patient regained consciousness shortly after fainting. Patient stayed a few minutes longer to be observed by medical provider and was then cleared to go home.
positive covid 19 nasal test; positive covid 19 nasal test; dose 3; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group.  A 58 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 17Nov2021 15:30 (Lot number: FD0809) at the age of 58 years as dose 3 (booster), single, intramuscular, administration date 10Apr2021 10:00 (Lot number: EP6955) as dose 2, single and intramuscular, administration date 20Mar2021 10:00 (Lot number: EP6955) as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing); "known allergies: yes" (unspecified if ongoing), notes: known allergies: yes. The patient took concomitant medications.  The following information was reported: IMMUNISATION (medically significant) with onset 17Nov2021 15:30, outcome "unknown", described as "dose 3"; VACCINATION FAILURE (medically significant) with onset 09Jan2022 11:15, outcome "unknown", COVID-19 (medically significant) with onset 09Jan2022 11:15, outcome "recovering" and all described as "positive covid 19 nasal test". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  The patient was not diagnosed with COVID-19 prior to vaccination. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Random muscle twitching and sensation of vibrations in head and body. Now 4 weeks later it has NOT improved.
This spontaneous report was received from a medical assistant referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates (reported as from 06-DEC-2016 to 04-JAN-2017), the patients underwent the administration of improperly stored doses of PNEUMOVAX 23 lot # L019836, expiration date 24-MAR-2017 (dose and route of administration were not provided) for prophylaxis. There were no adverse events reported. Administered doses of PNEUMOVAX 23 were exposed to a temperature excursion of 35 degree F for 60 hours. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA007868: US-009507513-1701USA007869: US-009507513-1701USA007871: US-009507513-1701USA003063.
Patient received a 1st dose of Moderna. Moderna is not approved for patients under 18.
2/18  6 pm nasaues, dizzy, chills, headache  10 pm 103 fever , nasueas, dizzy, aches,pains, headache 2/19. 10am  fainted, vomiting, chills, fever  2/20 fever , felt I was fainting again, extreme body shakes , vomiting , headache, night sweats 2/21 nasueas, dizzy , nightsweats  2/22 nasueas, dizzy, headache
Pt sons called reported that his mother had bad reactions from TD vaccine given 07/12/04 on left deltoid muscles. Pt left arm with redness, swelling and very hot to touch with moderate pain. Pt son states also mom took Tylenol for pain on left arm.
Information has been received from a physician via company employees and a practice manager referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 01-APR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml Prefilled Syringe (PFS) (lot # K020795, expiration date 19-MAR-2016, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 16 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 64 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Expected sore arm. Extreme swelling, redness that extended way out from site and fever of shot site, headache, nausea. The headache and flu type symptoms lasted 4 days. The fever and swelling lasted another several. The redness (extended outward from shot site) lasted for 6-8 weeks. Felt awful and made me question if I even wanted to follow through with second vaccine. Took pics of arm and showed to nurse when receiving the second shot. She was amazed at the size and brightness of the redness. Second shot: sore arm as expected with much smaller area of redness around shot site with slight fever, slight headache for one day.
Approximately at 0200 on 10/08/2020, child fussy and fever (102 axillary). Child was fussy and crying. Fever and fussiness improved with Tylenol. Erythema at injection site, approximately 1-2 cm on right thigh, hot to the touch.
Patient said she had a red large circle mark a 2inches in diameter. I suggested ice and ibuprofen. She said it was slightly itchy, and I told her if it was no better on Wednesday 8/17 that I would give her some topical BENADRYL for the itch.
gave fluzone quadrivalent to a 2-month old,with no reported adverse event; Initial information was received on 14-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 months old and unknown gender patient who experienced gave fluzone quadrivalent to a 2-month old,with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Sep-2022, the patient received one dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7689LA and expiry-30-06-23) (dose, formulation and strength:unknown) via unknown route in unknown administration site for immunization.  On 14-SEP-2022 the patient developed a non-serious gave fluzone quadrivalent to a 2-month old,with no reported adverse event (product administered to patient of inappropriate age) (Latency same day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QUADRIVALENT) was not applicable.  At time of reporting, the outcome was Unknown for the event gave fluzone quadrivalent to a 2-month old,with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
4 weeks pregnant when received the vaccines. Started having  sharp abdominal pain approximately one week later, which led to miscarriage at 5 weeks