chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had the shot and still got shingles/suspected vaccination failure; little outbreak on face, uncomfortable; painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had the shot and still got shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: little outbreak on face, uncomfortable) and pain (Verbatim: painful). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 22-Mar-2023 The case was received from the patient via interactive digital media. The patient have had them three times, they were an uncomfortable and sometimes painful burden they seem to last a life time before they were gone and you were no longer contagious. The patient stated get the shot.  Yes the patient had the shot and still got shingles, but the impact lessens.  The patient stated that shingles might also be followed by neuropathy.  For the patient that was like getting stuck by a hat pin without warning.  This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
lymph node on the right side of her neck swelled; This case was reported by a nurse via call center representative and described the occurrence of enlargement of lymph nodes in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th September 2020, the patient received the 1st dose of Shingrix. On 4th September 2020, 8 hrs after receiving Shingrix, the patient experienced enlargement of lymph nodes. The patient was treated with BENADRYL (NOS) (BENADRYL). On an unknown date, the outcome of the enlargement of lymph nodes was recovered/resolved.   It was unknown if the reporter considered the enlargement of lymph nodes to be related to Shingrix.  Additional details were reported as follows: The case was reported by the nurse who reported for herself. The patient received the 1st dose of Shingrix and experienced  swelling of lymph node after 8 hours of vaccination which is recovered till the time of of reporting. The patient has taken benadryl for treatment of enlargement of lymph nodes which is resolved after 2 hours. The reporter did not consented to follow up. No further information was available.
swelling at both injection sites; arm pain; redness; shoulder pain; joint pain; muscle pain; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   The patient's past medical history included surgical procedure (surgically installed in her right clavicle). Concurrent medical conditions included cancer (recent cancer, in remission prior to Shingrix), chemotherapy and radiotherapy.   In August 2019, the patient received the 1st dose of Shingrix (intramuscular) and Influenza vaccine Quadrivalent 2019-2020 season. On an unknown date, less than 6 months after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced injection site swelling, pain in arm, injection site erythema, shoulder pain, joint pain and muscle pain. On an unknown date, the outcome of the injection site swelling was unknown and the outcome of the pain in arm and injection site erythema were recovered/resolved and the outcome of the shoulder pain, joint pain and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, pain in arm, injection site erythema, shoulder pain, joint pain and muscle pain to be related to Shingrix. It was unknown if the reporter considered the injection site swelling, pain in arm, injection site erythema, joint pain and muscle pain to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination not provided but it could be 75 or 76 years. In late August, 2019, the patient had dose one of Shingrix and an unspecified influenza vaccine on the same day. The flu shot was in the left arm, and Shingrix in the right arm.  The patient reports injection site pain at both the flu injection site and Shingrix site. She did experienced some swelling at both injection sites. The arm pain and redness resolved at both sites. The patient also reports shoulder pain which continues and has not resolved. It was in the right shoulder.  The patient had just been treated with radiation and chemotherapy prior to both injections. She had a port surgically installed in her right clavicle.  The patient was experienced the joint pain, muscle pain, and right shoulder pain. The follow up consent was not granted.
Left arm red, swollen, warm to touch, Keflex 250 mg PO TID.
Received varicella vaccine on 1/19/2021.  On 2/7/2021 broke out in varicella-rash covering entire body. Seen in clinic on 2/8/2021 where the lesions were tested and positive for varicella. No other symptoms besides rash. Mother is unaware of any exposures but child does go to daycare.
Discomfort; Fever; inflammation of the lymph nodes between armpit and breast/inflammation in the armpit; Inflammation; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Discomfort), INFLAMMATION (Inflammation), PYREXIA (Fever) and LYMPHADENOPATHY (inflammation of the lymph nodes between armpit and breast/inflammation in the armpit) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-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 DISCOMFORT (Discomfort), INFLAMMATION (Inflammation), PYREXIA (Fever) and LYMPHADENOPATHY (inflammation of the lymph nodes between armpit and breast/inflammation in the armpit). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, DISCOMFORT (Discomfort), PYREXIA (Fever) and LYMPHADENOPATHY (inflammation of the lymph nodes between armpit and breast/inflammation in the armpit) outcome was unknown and INFLAMMATION (Inflammation) had resolved.            No concomitant medications were reported by reporter.  Patient had an inflammation there in arm pit for about 10 days were in the left side.   This case was linked to MOD-2021-421181 (Patient Link).
About 12 hours after the vaccine (2nd dose) I developed fever, chills, teeth chattering (rigors), sweats, muscle aches and dry cough.  Other symptoms have resolved after 2 days - but some muscle ache persists - along with a dry, non-productive cough (worsened upon deep inspiration).  Although my overall sense of well being has improved over the few days since vaccination, the cough is persists and not improving.
Rash from head to torso and fever of 101.0 started the night vaccines were given (5/22/18).
This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a adult male patient who received ENGERIX B for prophylaxis. Co-suspect products included ENGERIX B for prophylaxis and ENGERIX B for prophylaxis. On an unknown date, the patient received the 1st dose of ENGERIX B, the 2nd dose of ENGERIX B and the 3rd dose of ENGERIX B. On an unknown date, unknown after receiving ENGERIX B, ENGERIX B and ENGERIX B the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to ENGERIX B, ENGERIX B and ENGERIX B. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that the patient who completed their series of ENGERIX B did not achieve immunity after 3rd dose. The health care professional was unsure when 3rd dose of series was administered. However, it was intended to administer additional booster dose and re-check titers at some point thereafter. No further information was reported. Lab Comments: Lab test was performed on an unknown date.
Vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medication were not reported.   This case was linked to MOD-2021-395985 (Patient Link).
Parents stated that pt developed a mild URI and vomiting 3 days post immunization and a fever of 102.  Parents brought pt in 2 weeks post immunizations for constipation and it was also noted at that time that pt's legs were "flacid".  Pt was sent to the hospital and worked up for Guillain-Barre'.  Pt had an LP, MRI, Chem panel, CBC Sed rate, CRP, TSH and a chest x-ray.  Guillain- Baree' was r/o 1/7/09-records received for DOS 12/19-12/21/08-DC DX: Hypotonia per history. Guillain-Barre ruled out.Atelectasis potentially due to some hypoventilation during sedation for MRI scan now improved. Event occurred 3 days after immunizations with flaccid and decreased spontaneous movement of lwer extremities.
Pt developed a rash with itching and a fever. Pt was diagnosed with chickenpox. The pt subsequently recovered.
This spontaneous report as received from a pharmacist via a company representative refers to an unspecified number of patients and unknown age and gender. On an unknown date the patients were vaccinated with ZOSTAVAX (dose, lot number and expiration date not reported) subcutaneous. There was no concomitant medication reported. Pharmacist mentioned other unspecified pharmacist stated that they have given ZOSTAVAX subcutaneous in the bicep area of the arm on an unknown date. No adverse effects reported. Additional information has been requested.
BLACK AND BLUE MARK ON LEFT ARM; ITCHING IN UPPER TORSO; This spontaneous report received from a patient concerned a 71 year old female. 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: 1805018 and expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced black and blue mark on left arm. On MAR-2021, the subject experienced itching in upper torso. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from black and blue mark on left arm, and the outcome of itching in upper torso was not reported. This report was non-serious.
3/22: Slight consistent cough, continued into 3/23.  3/23: Headache (severe in the morning, but subsided). Slight temperature, muscle aches (mostly across shoulders), chills, fatigue. 3/24: Headache (mild throughout the day). Muscle aches throughout the body, joint pain. Extreme fatigue. Easily winded. 3/25-27: Persistent muscle & joint aches and fatigue, all worse than earlier in the week. Cold symptoms (stuffy/runny nose). 3/28-29:  Persistent muscle & joint aches, but not quite as intense as previously. Same level of fatigue.
Generalized rash, redness, itching on torso pt used hydrocortisone cream topically and BENADRYL orally and states some relief from tx.
MA found that she had given this patient a Hep B vaccine instead of a Hep A. Before vaccines where administered they were double checked by another M.A. Incident report filed.
Patient had vaccines on 6/10/13 at 1045am. At 1:30 pm, she began crying and was unconsolable for 3 hrs. Then she slept for 21 hrs. Only walking briefly to take 1-2 oz of formula.
On Sunday at 4:30pm, I noticed hives. Later in the evening around 9pm, I noticed I was having hives so I went and got Benadryl. That Tuesday, the hives were getting worse so I went to urgent care and they told me I was having an allergic reaction to the booster shot. They prescribed Albuterol and Protozoan steroid pills on 12/28/2021. That Thursday night,  I had a fever that seemed abnormal and wasn't listed as a side effect to the steroid. So I contacted my PCP who told me to get off the Protozoan because it could compromise my immune system and told me to get a COVID-19 test. I went back to urgent care on 01/04/2022 because I still wasn't recovering, but I had an appointment with my PCP on 01/06/2022 so I was advised to take the Protozoan again until my appointment. I began taking it again after a follow-up appointment with my PCP on 01/08/2022 and was told to take it for 6 consecutive days (01/08/2022-01/14/2022) until I see an allergist on 01/18/2022. As of now, it's on and off, it varies day to day on when I feel side effects and symptoms.
little tiredness; 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 64 year-old female patient received bnt162b2 (BNT162B2), administration date 02Mar2021 (Batch/Lot number: unknown) as dose 1,single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "little tiredness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Death in an operating room during a simple ERCP procedure.  Very unexpected and unexplained.
This spontaneous report was received from a registered nurse referring to an 13 year old female patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 14-OCT-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored (incorrect product storage). This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA008666:
Pt said the pain started out from injection site and moved upwards to her arm, her left shoulder, her neck, and to the lower side of her head.
Pt reported pain/itching across right shoulder blade. Describes as sharp, prickly pain, skin sensitive to touch. Started day after ZOSTAVAX. Still having symptoms but not as severe. Symptoms associated with red bumps/rash (a few sores).
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE RASH (Rash at injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 11-Mar-2021, the patient experienced VACCINATION SITE RASH (Rash at injection site). On 04-Mar-2021, PAIN IN EXTREMITY (Sore arm) outcome was unknown. At the time of the report, VACCINATION SITE RASH (Rash at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   ? No treatment information was provided.
2/17 Two weeks after vaccine 2nd dose, my lymph nodes were swollen and was told to allow it run it's course. Later pain in neck increased and sought care for it. Was referred to massage therapist where after 3 sessions was referred to a specialist who after the first session with her on 04/24 was able to  decrease pain significantly and restore about 90% movement to my neck.
Shoulder pain, aching from shoulder to elbow, weakness, painful to move arm for 2 weeks...went to primary physician, put on steroids and Benadryl with some relief....pain returned when steroids finished. Returned to Dr. and placed on another round of steroids with relief. Still sore while on steroids but improved. Pain and loss of motion returned when steroids done. I am now 5 1/2 weeks out from date of injection and returning to dr. on Mon. Nov. 8 because of the pain and loss of motion in my Left arm.
I had a sore arm for a day after receiving the vaccine. Two weeks prior to receiving the COVID-19 vaccine I had my first Shingrix vaccine. On 05/30/2022, I began feeling malaise. On 05/31/2022, I had vertigo and dizziness. I have been to my primary care physician and specialist. They are testing to see if I had the vaccines to close together.
Had 12 month vaccines on 9-13-06 MMR, VZV, Prevnar, Hepatitis A.  Broke out with "red, bumpy rash" the day after (9-14-06)
Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. Information about patients' concurrent conditions and medical history was not reported. On unspecified dates the patients were vaccinated with M-M-R II (dose, route not reported, lot# J016234 with expiration date 19-DEC-2015) that had been improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
medication error due to PENTACEL being given to a 6 year old instead of DAPTACEL with no reported adverse event; medication error due to PENTACEL being given to a 6 year old instead of DAPTACEL with no reported adverse event; Initial information received on 02-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 years old male patient who had medication error due to DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] being given to a 6 year old instead of daptacel with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included POLIO VACCINE INACT 3V (VERO) (IPOL POLIO VACCINE) for Prophylactic vaccination; VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Prophylactic vaccination; and TUBERCULIN PPD (TUBERSOL) for Prophylactic vaccination.  On 02-Aug-2022, the patient received a 0.5ml 1X(once) dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (strength, formulation was unknown, lot C5840AA and expiry date: 03-Jun-2023) via intramuscular route in the right deltoid.  On 02-AUG-2022 the patient developed a non-serious event of medication error due to pentacel being given to a 6 year old instead of daptacel with no reported adverse event (wrong product administered) (product administered to patient of inappropriate age) (Latency: same day) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken : not applicable.  Outcome: Unknown  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.
Fercrisness, headache, muscle ache, arm pain, redness. Asthma symptoms
Information has been received from a physician concerning a male patient who was vaccinated with a dose of PNEUMOVAX. Subsequently the patient experienced swelling at the injection site. The patient was treated with KEFLEX, over the counter BENADRYL and ice. Subsequently, the patient recovered. No product quality complaint was involved. This is one of two reports from the same source. Additional information has been requested.
This was the Johnson&Johnson vaccine. I had covid in January, and this was similar to having it all over again. Awoke night of vaccination at 0130 with bad case of chills and shakes. Awoke again at 0330 with same. Took an ibuprofen at that time, which ameliorated problem. Had a headache for 36 hours. Awoke in the morning exhausted with headache. Next evening, awoke in the middle of the night with soaking wet PJs. Still lethargic and not feeling normal 48 hours later.
I was diagnosed with rheumatoid arthritis back in July. I first started having symptoms back in February or March of 2022.
Information has been received concerning a 21 year old female with penicillin allergy who was vaccinated with Gardasil. Concomitant therapy included hormonal contraceptives (unspecified). Subsequently the patient experienced pain in the arm she was administered Gardasil. The pain radiated up her shoulder an into her back. She was not able to lift her arm without pain. She tried using a heating pad and an ice pack but neither helped. Additional information has been requested.
Pt states she began experiencing flu like symptoms around 3:00. Pt states around 8:00 PM she lost vision. Pt states this lasted for approximately 24 hours.
States "broke out in red bumps and whelps and itching all over body - back of head, back, arms, hands, in folds of skin" on Sunday afternoon after receiving flu vaccine on Thursday afternoon. Treated at home with Benadryl and Zyrtec.
Pain at site of injection (left deltoid). Pain and stiffness left deltoid muscle and left shoulder.
Maculopapular rash over MMRV site, perhaps 4x4. No nodal involvement, no cellulitis.
Initial nurse report received on 21 Jul 2010: This patient received MENVEO (batch number: 090901) unknown dose intramuscularly on 15 Jul 2010. It was report that on 15 Jul 2010, the patient was administered only the liquid Men CWY conjugate component of MENVEO instead of being reconstituted with Men A conjugate component. No adverse event had occurred due to this. The outcome and causality was not reported.