chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a consumer referring to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 23-OCT-2018, the patient was vaccinated with GARDASIL 9 (strength, dose, dosage schedule, lot # and expiry date were not provided) for prophylaxis. On an unspecified date in 2018 (reported as an unspecified amount of time after receiving a dose of GARDASIL 9), the patient developed injection site pain, warmth, and bruising, as well as a raised knot at the injection site; the patient also reported that it felt like her arm muscles were bruised and that it hurt to raise her arm and the pain woke her up at night. The patient stated that all symptoms resolved except the raised knot until 11-NOV-2018 (reported as yesterday) when all other symptoms returned. The patient reported there was no explanation for the return of the symptoms as she had not injured her arm in any other way. The outcome of the events was not resolved. The reporter's causality assessment between GARDASIL 9 with injection site pain, pain in extremity, muscle contusion, injection site nodule, injection site bruising and injection site warmth was not reported.
post excursion menactra administerd to child with no AE; excursion of 31.7F to 52.4F for 300 hours due to a refrigerator malfunction (not human error) with no adverse event; Initial information received on 22-Jul-2022 regarding an unsolicited valid non-serious case received from other health professional.   This case involves 8 years male patient to whom post excursion menactra was administered with no ae and excursion of 31.7f to 52.4f for 300 hours due to a refrigerator malfunction (not human error) with no adverse event while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].   The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    The condition from 05-Apr-2022 to 15-Jul-2022 was a range from 31.7F to 52.4F for 300 hours due to a refrigerator malfunction (not human error). The product was not supported by the extended stability data.   On 20-Jul-2022, the patient received suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE at a dose of 0.5 ml (lot V1A121M, expiry date: 15-Feb-2024) via intramuscular route in Left Deltoid for immunisation.   On an unknown date in 2022 there was excursion of 31.7f to 52.4f for 300 hours due to a refrigerator malfunction (not human error) with no adverse event (product storage error) (unknown latency) following the administration of meningococcal A-C-Y-W135 (D CONJ) vaccine.  On 20-Jul-2022 the patient was administered post excursion menactra with no ae (poor quality product administered)(latency: same day) following the administration of meningococcal A-C-Y-W135 (D CONJ) vaccine.  Action taken: Not applicable.   Outcome was Unknown for the event post excursion menactra administerd to 8 years old child with no ae and was Unknown for the event excursion of 31.7f to 52.4f for 300 hours due to a refrigerator malfunction (not human error) with no 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.
This spontaneous report as received from a office administrator refers to a 2 month old patient. On an unknown date, the 2 month old patient was vaccinated with one dose of PNEUMOVAX 23 from lot N023651 expiry date 20-MAY-2019 for prophylaxis. No adverse effect reported. No product quality complaint involved.
Missed the second dose of vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed the second dose of vaccination) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Surgery since an unknown date.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed the second dose of vaccination). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed the second dose of vaccination) outcome was unknown. Not Provided.          No treatment information was provided. No concomitant product use was not provided by the reporter.  Action taken with mRNA-1273 in response to the event was not applicable.
Infertility issues, one year of trying to conceive (5/2020-5/2021), received pfizer vaccine in 1/2021. Found to have elevated prolactin levels on lab testing in 4/2021, determined idiopathic and started on dopamine agonist medications (cabergoline) in May 2021.
EXTREME SORENESS IN LEFT ARM WHICH SETTLED INTO LEFT SHOULDER. I LOST MOBILITY IN MY LEFT ARM. EXTREME SORENESS AND THROBBING IN LEFT SHOULDER. AFTER 20 VISITS TO PHYSICAL THERAPIST, I BUILT UP STRENGTH IN LEFT ARM AND SHOULDER. HOWEVER, I STILL HAVE NOT REGAINED EQUAL MOBILITY TO MY RIGHT ARM AND SHOULDER.
After administering vaccines patient had a syncopal episode that lasted 3-5 seconds. Applied cold compress, had patient sip water slowly, made patient to continue to lay on exam table.  Monitored patient for 15 minutes and obtained vitals: b/p:120/74 left arm ,patient was alert, oriented x3.  Patient was seen  ambulating down hallway accompanied by mother with no signs of distress noted.
Information has been received from a female patient, with no known drug reactions/allergies and no pertinent medical history, who was vaccinated with three doses of GARDASIL. There was no concomitant medication. The consumer stated she is seeing a new doctor and the doctor provided her with a fourth dose of GARDASIL. She also mentioned she vomited and turned pale white taking the doses of GARDASIL. No further information is available.
So, on 4/7 I woke up with a sore throat, but I thought it was allergies. The next day I woke up with a sore throat. It progressed into the night. I had a headache, sore throat, congestion, difficulty breathing, aches and pains and a very bad headache. It felt like someone was hitting me with a sledgehammer. I called my local provider, and I had a telehealth visit and they prescribed me with Paxlovid. Sunday night was my first dose. I do feel better, but I don't think I'm over it completely.
Information has been received from an RN concerning her 12 month old son with developmental delay, microcephaly (not cerebral palsy), seizure and cognitive disturbance (unable to communicate verbally) who in approx. 2/99, was vaccinated with varicella virus vaccine live. On approx. 11/21/01, the pt developed seizures which were worse than usual. On approx. 11/23/01, the child became cranky, crabby and miserable. His mother noted "mosquito-bite" like lesions in his diaper area. The mother called her physician who at that time did not consider the lesions to be chickenpox because blisters did not appear. The child was unable to sleep that night and the next day, the child developed blisters, some of which were "blistery". The blisters appeared on his left upper thigh and leg (approx. 10), trunk between the abdomen and chest (4 to 5), neck (2) and ear (1). The mother reported that she felt that the blisters were mild and she was able to count the lesions. The mother also reported that approx. 3-4 weeks prior to the appearance of the blisters, she received a letter indicating that someone in her child's school had developed chickenpox. Her son had not had direct contact with the person in question. The child was treated with acetaminophen (Tylenol) "around the clock" and did not develop a fever at any time. The child recovered from "his experience". The RN also reported that her other son developed chickenpox while on therapy with varicella virus vaccine live (WAES0112USA01812). Additional information has been requested. Follow up info from a physician indicated that the child "did not have any reaction to the vaccine." The report was only filed because in December 2001 the child developed varicella infection despite having had the vaccine. Upon internal review the seizures were considered an other important medical event (OMIC). The registered nurse also reported that her other son developed chickenpox after receiving varicella virus vaccine live (WAES0112USA01812).
HEALTH PROBLEMS; HAD COVID SEVERAL TIMES; This spontaneous report received from a patient via a company representative concerned multiple patients. 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case.  No concomitant medications were reported. On an unspecified date, the patient experienced health problems, and had covid several times. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the health problems and had covid several times was not reported. This report was non-serious. The report is associated with product quality complaint.
Patient received Janssen Covid-19 vaccination today at approximately 6:20pm.  At 6:35, he said he had left arm weakness (arm he received vaccine in), fatigue, was dizzy, and felt "off".  Patient did not lose consciousness and refused an ice pack.  BP checked at 6:38pm (170/98, pulse 105).  Patient stated his blood pressure usually runs high. I offered him an ice pack a second time, but he said there was no need and he felt better.  BP checked again 6:52pm (152/101, pulse 99).  I recommended that since his blood pressure is usually this high, he should follow up with his primary doctor regarding blood pressure as he may need some medication to assist in lowering it.  He said ok.  He left the pharmacy area at 7:02pm and said he was fine to leave, he did not want to remain any longer.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were intramuscularly vaccinated with RECOMBIVAX HB (dosage schedule was not reported) which had been improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Atypical menstruation- patient (myself) has an IUD in place and has not menstruated in over 4 years.  Menstruation started 4 days after 2nd dose of Moderna vaccine.  No other signs of abnormal bleeding/ITP. Only minor lethargy and soreness 1 day after vaccination.
Expired dose administered to 7 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 7 patients) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21B) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 7 patients). On 19-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 7 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter stated that they administered 7 doses of an expired vial of Moderna COVID 19 Vaccine to 7 patients on 19 January 2022. The expiry date of vaccine was on 14 January 2022. Date of Vaccination for first and second doses and their lot numbers were unknown. Reporter mentioned no adverse events were observed in any of the patients and stated that no treatment was given to the patients. Patients were not under any concomitant or regular medication.
Covid19 breakthrough.  1st Vaccine received on 03/30/2021.  48 y/o with PMHx of Asthma, CHF, COPD, DVT, DM, OSA, CKD presents to ED with c/o increasing SOB since yesterday.  Recent exposure to +family members.  Room air sat 87% requiring O2 @5L NC.  CXR low lung volumes.  Started on IV steroids and Remdesivir.
This initial spontaneous case, was received on 19-Oct-2017, from other non-health professional, concerning a 53-year-old female adult patient. The patient had no relevant medical history and concomitant medications were not reported. On 17-Oct-2017, the patient was administered with AFLURIA (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: XT59806, expiry dateL 05-JUN-2018). On the same day, the patient experienced decreased level of consciousness (altered mental status at work and reported possible seizure). The patient was taken to emergency room and CT (computed tomography) scan was performed which was negative. It was reported that the seizure was not confirmed and not witnessed by the medical personnel. It was not certain whether altered mental status at work was a part of decreased level of consciousness. The patient recovered from the event on the same day. The reporter assessed the event as non-serious. Follow-up received on 09-Nov-2017: The CT scan was negative. It was reported that the seizure was not confirmed and not witnessed by the medical personnel. It was not certain whether altered mental status at work was a part of decreased level of consciousness (hence coded as 2 separate events). Narrative amended accordingly. Non-significant case correction received with code 19-OCT-2017: Case opened in error.
21SEP94 t99.4, joint pain rt ankle, both wrists & knees;
Per client post vaccine felt lightheaded and felt hot, and sob. Client states did not eat this morning, reports last meal was at 7pm last night.  EMT and MD assessed, BP 132/90 @ 130pm, second BP 122/88  at 2pm , oxygenation 97%.  Client remained in observation , left with parent without incident.
My husband had it so I  quarantined with him, I decided to get tested myself when I went to my Dr. I tested positive on 6/21/2022. My Dr. prescribed Dexamethasone , and Cephalexin
2nd shot, Left Arm swelled with pain.  Went to PCP and diagnose with Cellulitis so I thought it was.  3rd shot, same symptom so I thought it was "normal" but swelling and pain continued and still going on until 9 Sep 2022.
The patient had the ZOSTAVAX IMZ administered on Tuesday, Sept 27th. Today, Friday Sept 30th, she came in and showed me a red circular rash around the injection site stating it hot to the touch. I felt the area and it was warm. Additionally, the pt stated her arm was very week, "like I lifted weights and over-exerted". I told her she should consider going to the MD. I also advised her to apply a cold pack to the area of concern 4 times daily for 10-15 minutes and take ibuprofen for the next 3 days to assist with the swelling. She said she wanted to wait until Monday to call the doctor to see if the symptoms improved. I told the patient I would contact her MD, which I left a detailed message with office staff including that I advised the patient to be seen if symptoms do not improve. I told her I would follow up with her on Monday to see how her symptoms were.
her little sister got GARDASIL 9 and felt a little sick after the immunization; This spontaneous report was received from other referring to a female patient of unknown age. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were unknown.   On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route, batch/lot# and expiration date were unknown) for prophylaxis.   On an unknown date, the patient felt a little sick after the immunization. It was unknown if medical attention was sought. It was unknown if any treatment was given to the patient. It was unknown if any lab diagnostic/study was performed. The outcome of the event was unknown. The causality assessment was not provided.
My inner core began to feel as though it was shaking or pulsing, but no visible shaking on outside of body. It is an odd sensation I have never felt before. This has persisted daily and spread to legs and chest. Primarily, the sensation is felt when laying in bed, or when still.   Also note: After first dose, within minutes, I began to have a metallic taste in my mouth that continued for about 5 days.
This case was reported by a other health professional via call center representative and described the occurrence of shingles in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, immediately after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional information received as follows: This was reported by Internist. The healthcare professional reported that the patient developed shingles after receiving the SHINGRIX vaccine.
This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Shingrix for prophylaxis. The patient's past medical history included atrial fibrillation (recent cardioversion). In September 2018, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, 1 day after receiving Shingrix, the patient experienced fever, nausea, chills and nonspecific reaction. Shingrix was discontinued. On an unknown date, the outcome of the fever, nausea, chills and nonspecific reaction were unknown. It was unknown if the reporter considered the fever, nausea, chills and nonspecific reaction to be related to Shingrix. Additional details were reported as follows: This case was previously reported to the physician. The patient who received a dose of Shingrix experienced severe reaction the next day of fever, chills, shivering and nausea. The patient would not going received 2nd dose of Shingrix vaccine due to this reaction. The patient had denied permission to contact their physician. This case was linked with case US2018192638, reported by the same reporter.
30 minutes after injection: severe headache, general feeling of illness. Following day in the morning, headache, left arm in extreme pain, facial numbness, disorientation, inability to talk, confusion, difficulty breathing
Brain fog; Pins and needles feeling in lower legs and feet; Fatigue; Muscle aches; Nauseated; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 16Apr2021 at 15:00 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included gastroesophageal reflux disease (GERD), irritable bowel syndrome (IBS) and anxiety. The patient had no known allergies to food, medications or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified concomitant medications. On 16Apr2021 at 17:00, the patient experienced brain fog, pins and needles feeling in lower legs and feet, fatigue, muscle aches and nauseated. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events brain fog, pins and needles feeling in lower legs and feet, fatigue, muscle aches and nauseated were resolving at the time of report.   No follow-up attempts are needed. No further information is expected.
Localized inflamatory erythematous reation. 3cm in diameter and tender to palpation.
Ten minutes post vax, pt became edematous, vomited, limp and shock-like. Given Adrenaline stat and rushed to ER where she received IV Benadryl and steroids. Physicians notes state that oropharyngeal swelling or redness occurred with swelling to orbit and lower lip. Stated in hospital report that experienced acute allergic reaction to vax.
Brain fog, fatigue, swollen and sore lymph node in armpit of arm where shot was given
Patient received second dose of medication after not concerns or issues with first dose. After approximately 25 minutes the patient started experiencing chills, dizziness and tightness in chest. The patient stated no issue with breathing but was provided water and was monitored with bedside care following concerns. Patient started experiencing labored breathing at approximately 11:50AM. Explained that his throat was feeling tight but was fine. Coached through breathing techniques and color was changing to more pale. Benadryl and Epi prepared. Patient was provided Benadryl as he was stating his throat did not feel "tight" rather he was feeling weight in his chest when breathing. 50mg of liquid Benadryl was administered at 11:52AM. Within 3 minutes patient  color was returning and breathing was coming with more ease. Patient seemed more relaxed and stated he was feeling better. More water and close monitoring. Patient stated chills still present and fingers were cold 12:00PM. Provided blanket.  Patient stated on sight from 11:00-1:00. Patient was feeling no concerns with breathing, chills were subsiding at 12:30pm. He was provided Benadryl, Tylenol and water to go home to father's care. He was provided option to be taken to walk in clinic or ER for further evaluation but stated that he felt comfortable with going home as he felt like himself.
shingles; burning sensation on left hip; This case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd July 2021, the patient received the 1st dose of Shingrix (intramuscular). On 22nd July 2021, 3 hrs after receiving Shingrix and an unknown time after starting acyclovir, the patient experienced shingles and burning sensation. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles and burning sensation were not recovered/not resolved.   It was unknown if the reporter considered the shingles and burning sensation to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The age at vaccination was not reported. The patient received 1st dose of Shingrix and right after experienced burning sensation on her left hip. The patient went to the health care professional who confirmed the case of shingles. The health care professional had  started the patient on acyclovir treatment. The patient said that the shingles were not cleared up completely. The reporter did not consented to follow up.  Note- there was discrepancy in the reported time to onset for the event burning sensation. In the event section of source document, TTO is provided as 3 hrs but in narrative it is mentioned as right after. However TTO for burning sensation and shingles captured as per structured field.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR175923:Vaccine case (Shingrix)
pt recv vax; 10 min p/ vax started w/ pruritus & hive-like rash lesions on extremities; pruritic erythematous papules on extremities; r/o allergic dermatitis; DPH & cool baths given;
02/14/2006 Received MCV4 and HBV - Saturday and Sunday felt headachy.  Tuesday 02/212006 fever, headache and nausea, highest 99.2 degrees - headache continues, nausea subsided.  Complained of tiredness before vaccine.