chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had them  shots years ago, years later Dr said got shingles; shingles; itchy place on his Back; miserable; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pruritus and feeling miserable. On an unknown date, the outcome of the vaccination failure, shingles, pruritus and feeling miserable were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pruritus and feeling miserable to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 28-JUN-2022 Reporter's Comment: The patient's wife reported this case via interactive digital media. The patient received shots of Shingles vaccine years ago and years later he had an itchy place on his Back. The reporter thought the patient had scratched it. The patient went to doctor and he said the patient got shingles. It ended up in 2 places. The patient was miserable but never complained. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Information has been received from a health professional concerning a 9 year old white, female, with no medical history or allergies, who on 08/16/1996 was vaccinated with a subcutaneous first dose in the left thigh of varicella virus vaccine live.  It was noted that there was no illness at the time of vaccination and no adverse events following prior vaccination.  It was reported that the patient developed chickenpox.  There were no laboratory or diagnostic tests performed.  Unspecified medical attention was sought.  No product quality complaint was involved.  Follow up information from a health professional indicated that the patient developed approximately 100 apparent pox lesions after two brothers with the same symptoms.  It was reported that the patient was seen in the office at the end of the episode for an unrelated illness.  The patient's status was reported as recovered.  Follow up information from a health professional indicated that the patient received the vaccination and still contracted chickenpox.  The patient's mother reported the disease.  It was noted that child was not seen at the office during the illness.  It was also reported that the patient had no adverse reaction to the vaccination.  Additional information is not expected.
Narrative:  COVID infections following completion of COVID vaccine series 01/06/21 COVID vaccine dose #1 02/03/21 COVID vaccine dose #2 07/23/21 Son notified care team that pt contracted COVID last Friday (07/16) and passed away on Wednesday (07/21) at hospital; son noted mom had runny nose last Monday and by Friday she had a fever; wife and pt were then tested and positive for COVID; son reports pt did not have initial symptoms but by Wednesday night, the pt was delirious; EMS found pt unresponsive and hypoxemic in respiratory failure and transported to ED; admitted to ICU and treated with mechanical ventilation, cardizem, Neo-synephrine, Propofol, Zithromax, Rocephin, Decadron, Lovenox, Amidate, Pepcid, Remdesivir, Anectine
Pt received first dose of Pfizer vaccine at 9:00 am approximately around 9:03 patient stated she did not feel well, patient complained of feeling faint, has pt recline in seat, and told her to take sips. Pt did pass out, at which time rescue was called, BP was 64/38 at this time, pt did become aroused BS was 102, pulse 68 pulse ox 96% BP did come up to 80/60. Rescue arrived and pt was transported to back of rescue for assessment. VSS stabilized patient felt much better and refused transport to ER. Her husband was with her to transport and pt will follow up with her PCP
This spontaneous report received from a nurse refers to 4 year old patient. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 01-SEP-2016, the patient was vaccinated with improperly stored M-M-R II lot #M004305 (dose, frequency, expiry date were not reported) for prophylaxis. The vaccine was purchased with private funds/insurance. The temporary temperature excursion occurred in the fridge on 01-SEP-2016 however, it was not discovered until 26-SEP-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA013814: US-009507513-1609USA014830: US-009507513-1610USA004339.
I started with an upset stomach on the morning of Saturday, 3/13/2021, which then culminated in diarrhea.  By the afternoon I experienced chills and fatigue.  Overnight I also had nausea although I never vomited..  On Sunday I couldn't get out of bed until late afternoon.  I felt like I couldn't move I was so fatigued.  I tried to stay as hydrated as possible by drinking water and I ate some soup.  I felt better on Monday although I was still tired and my stomach wasn't quite back to normal.  By Tuesday I was eating mostly normally.
patient received a Flu shot from an extended shipment of Fluzone Quadrivalent, no AE; Based on information received on 04-Oct-2019, the report previously considered as non-valid became valid: patient identifier reported.  Initial information received on 27-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer in United States.   This case is linked to cases 2019SA278134, 2019SA278135, 2019SA278136, 2019SA278137, 2019SA278138, 2019SA278139, 2019SA278140 and 2019SA278141 (same reporter).  This case involves patient of an unknown demographics who was administered with a dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] lot UJ254AC (Expiry date 30-Jun-2020) via unknown route in unknown administration site on 27-Oct-2019.  It was a actual medication error case due to incorrect product storage.  It was reported that on 27Oct2019 nine patients received a Flu shot from an extended shipment of Fluzone Quadrivalent.  At the time of reporting, no adverse event was reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.  Follow-up information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.   Case became valid. Event description updated.  List of documents held by sender: none.
This case was reported by a healthcare professional and described the occurrence of lump at the injection site in a 25-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). There were no concurrent medications.  On 2 September 2008 at 10:00 the subject received unspecified dose of FLULAVAL at 0.5 ml, subcutaneously, in the left arm.  On 3 September 2008, 24 hours after vaccination with FLULAVAL, the subject experienced lump at the injection site, injection site warmth and injection site redness.  The drug was also administered via the incorrect route.  FLULAVAL should have been given intramuscularly.  At the time of reporting the events were unresolved.  This event occurred in three subject.  Linked cases include A0745549A and A0746650A.
While getting ready for work, I noticed a large red splotch on my arm where I received the injection. I had not noticed this prior to the morning of 04/19/2021.  No itching, or soreness. Just a large (approx. 2 inches) red blotch.
Redness, swelling, pain. Ice, TYLENOL, BENADRYL.
administered adjuvant only portion; administered adjuvant only portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th July 2022, the patient received the 1st dose of Shingrix. On 6th July 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 07-JUL-2022 Reporter's comment: Medical assistant reported that the patient was administered only the adjuvant portion of Shingrix. The adjuvant was not reconstituted with the lyophilized powder portion. The reporter did not have the lot number or expiration date information available at the time of call. The dose had not been repeated at the time of reporting. The reporter consented to follow-up. Additional Supportive Information: The patient was administered only the adjuvant portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The case US2022104536 was identified as duplicate of this case. The case US2022104536 was deleted and all future correspondence would be added in the present case which stands as case of record for this patient.
Fever of 100.5 for a day and a half, aches & pains & fatigue. Sore arm for 1 week.
left arm hurting for a day or so; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (left arm hurting for a day or so) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A or 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE PAIN (left arm hurting for a day or so). At the time of the report, VACCINATION SITE PAIN (left arm hurting for a day or so) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No relevant concomitant medications were reported. Treatment information was unknown.  Reporter stated that the first shot probably hurt more than the second dose.   This case was linked to MOD-2021-406174 (Patient Link).
an expired dose of VAQTA was administered to a patient today.; This spontaneous report was received from a Certified Medical Assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions, or concomitant medications.      On 01-NOV-2022 (reported as "today"), the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) prefilled syringe lot # U024378 with an expiration date on 22-OCT-2022, for prophylaxis (dose, route of administration, and anatomical location were not reported). It was specified that product was stored according to it's label prior to being administered.
arm is really sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm is really sore at the injection site) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (arm is really sore at the injection site). At the time of the report, VACCINATION SITE PAIN (arm is really sore at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were provided by reporter.
Initial report received via search of scientific literature on 20 March 2012. The following is verbatim from the article abstract: "PURPOSE: A new meningococcal conjugate vaccine (MCV4) was introduced in 2005. Shortly after, case reports of Guillain-Barre syndrome (GBS), a serious demyelinating disease, began to be reported to the Vaccine Adverse Event Reporting System. In 2006, the Centers for Disease Control and Prevention and the Food and Drug Administration requested the evaluation of GBS risk after MCV4 vaccination. We conducted a study to assess the risk of GBS after MCV4 vaccination using health plan administrative and claims data together with the review of primary medical records of potential cases. METHODS: Retrospective cohort study among 12.6 million 11- to 21-year-old members of five health plans with a total membership of 50 million. Automated enrollment and medical claims data from March 2005 through August 2008 were used to identify the population, the vaccinations administered, and the medical services associated with possible GBS. Medical records were reviewed and adjudicated by a neurologist panel to confirm cases of GBS. The study used distributed data analysis methods that minimized sharing of protected health information. RESULTS: We confirmed 99 GBS cases during 18,322,800 person-years (5.4/1,000,000 person-years). More than 1.4 million MCV4 vaccinations were observed. No confirmed cases of GBS occurred within 6 weeks after vaccination. The upper 95% CI for the attributable risk of GBS associated with MCV4 is estimated as 1.5 cases per 1,000,000 doses. CONCLUSIONS: Among members of five health plans, MCV4 vaccination was not associated with increased GBS risk." Documents held by sender: None.
Patient came to pharmacy and reported: Headache, body ache, fever, lightheadedness, and redness on arm due to injection side reaction. She said has been in bed for 4 days.
Redness and mild swelling of upper left arm in the triceps location. No pain mentioned.
Pt had hoarseness of voice at night after given called on call dr. was told to give BENADRYL & contact us. Child was hoarse next am and fine by afternoon.
Employee received initial Covid vaccine on 01/04/21 in lt deltoid area and developed pain in left elbow 72 hours post vaccination. Pain began subside over coming weeks and was nearly resolved by 1/22/21 when employee was seen for 2nd vaccine which was given in rt deltoid. EE reported that he had elbow pain but that it was nearly gone at time that he received 2nd dose. 48 hrs post 2nd vaccine EE began to experience sharp severe pain at same lt elbow and pain is still persisting currently. It is interfering with his ability to lift and his grip strength on the left at this time due to severity of pain. He agrees to be evaluated.
She is experiencing itchiness and a swollen injection site; She is experiencing itchiness and a swollen injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a regulatory authority Support (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 30Apr2021 (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: PRURITUS (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset May2021, outcome "unknown" and all described as "She is experiencing itchiness and a swollen injection site".  Additional information: Caller got the first dose of the vaccine on 30Apr2021, and the second dose is scheduled on 21May2021 (correct dosing schedule). Caller said that 10 days after the first dose she experienced itchiness and a swollen injection site, and she was asking if the first or second dose has extended relief.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax & devel SOB, wheezing, perspiring, cyanotic;5:50 epi given;02 by mouth;BP 110/60, P84;MD notified;pt having bilat wheezing;gen rash & itching;breathing tx repeated;
Pain in left arm, shoulders and neck for 2 days. Night sweats, chills, fatigue and nausea for 2 days. Joint pain for 2 days.
Bell's Palsy started ~ 5 weeks after 2nd Moderna Covid-19 Vacc.
Fever, aches in knees and lesser aches over entire body.  Tiredness, dry cough.
Patient's arm swelled at the site and swelling continued down upper arm and became itchy. Patient was still at the Dr.'s office when symptoms began. Dr. prescribed Benadryl and an ice pack
Developed a half dollar sized lump with a softball sized area of redness around injection site 4 days after varicella vaccine. No tx-only phone call.
Syncope for 15-30 sec. head trauma. Neg. concussion screen test.
Odd sensation to feet. Persistent myalgias, fatigue "not feeling well", c/o joint pain, weakness. labs = CBC with diff, ESR, TSH, T4, CPK, LFT's, Tick panel. Referral to Rheumatologist, MD. Referral to neurologist, MD. Electrodiagnostic studies (performed at Neurologist).   12/22/08 MR received with VAERS report with DX:  Acute Inflammatory Demyelinating Polyneuropathy (GBS). WCC 10/9/08 with vax (TDaP and Varicella) given.  Returned 10/20/08 with c/o body soreness, weakness, fatigue and joint pain x 1 week. Assessment:  Myagia and myositis.  Fatigue. Seen again 10/27/08 with worsening sx. PE (+) for enlarged cervical lymph nodes and leg tenderness. Assessment:  Arthralgias and Fatigue.  Referred to Rheumatologist with ? fibromyalgia dx. Reporting difficulty walking by 11/26/08. DX:  Acute infective polyneuritis. Neuro consult 12/1/08. PE (+) for muscle weakness, areflexia, decreased sensation in leghs, and ataxia. DX: GBS to be treated with IVIG.  02/01/2010 Gillian Barre, required Neurologist eval and tx frequently entire year.
A non-serious spontaneous report of positive influenza A test was received from a physician concerning a 14 year-old male, subsequent to FLUMIST. The, patient received FLUMIST on 01-Oct-2008. On 09-Feb-2009 the patient tested positive for influenza A. The outcome and causality of the event to FLUMIST were not reported.
Information has been received about a pt who developed cellulitis post vaccination. the pt was seen by a physcian and treated with antibiotics.
body aches; This non-serious case was reported by a physician via sales rep and described the occurrence of general body pain in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced general body pain (Verbatim: body aches). The outcome of the general body pain was not reported.   It was unknown if the reporter considered the general body pain to be related to Shingrix.     It was unknown if the company considered the general body pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 24-OCT-2023 HCP stated that in general patients get body aches. No specific details were provided The reporter consented to follow up.
The day after the vaccination the patient developed induration, inflammation, and erythema approximately 5 inches in diameter at the injection site which is hot to the touch.
Initial report was received 17 September 2012 from a health care professional. A 24-year-old female patient had received an intramuscular injection of ADACEL, lot number C4136BA (site not reported) on 07 September 2012, and 24 hours later, she developed fever and headache that lasted two days. The patient had an insect bite on her left leg on 14 September 2012. The next day on 15 September 2012, she was seen in the office for severe hives widespread over her body. She had no difficulty breathing or swallowing. Corrective treatments consisted of Prednisone on 16 September 2012 with some relief to hives. The patient experienced a recurrence of hives overnight and was currently in the office for evaluation at the time of the report. Outcome was not recovered. Document held by sender: None.
Had generalized sz w/fever up to 103.1; Hyponatremia (NA=130), but normal electrolytes, WBC=12,900; CSF & Blood showed no bacterial growth; Normal CT of head; Event occured 2-3 days p/MMR/HIB;
Red patch; Itchy; swelled; Bumpy; Very Hot; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red patch), PRURITUS (Itchy), SWELLING (swelled), VACCINATION SITE MASS (Bumpy) and VACCINATION SITE WARMTH (Very Hot) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced ERYTHEMA (Red patch), PRURITUS (Itchy), SWELLING (swelled), VACCINATION SITE MASS (Bumpy) and VACCINATION SITE WARMTH (Very Hot). At the time of the report, ERYTHEMA (Red patch) had not resolved and PRURITUS (Itchy), SWELLING (swelled), VACCINATION SITE MASS (Bumpy) and VACCINATION SITE WARMTH (Very Hot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
J&J vaccine-brief bilat nare epistaxis, chills, tremor, diarrhea, numbness and tingling to all 4 extremities
Vertigo, dizziness, brain fog minutes after, then roughly weekly each week thereafter. No treatment.
While walking out of exam room, child fainted . Fell backwards to floor to floor striking the back of her head on floor.  LOC < 1 minute monitored in office as described below.  & nauseous  No HA No vomiting; reassuring exam 3 & vitals. Given Hydration & glucose (lot pop)
This spontaneous report as received from a other health professional (healthcare worker) refers to unspecified number of unspecified patients. On unspecified dates since 28-OCT-2014 the patients received unspecified number of doses of RECOMBIVAX HB, intramuscular, which had been improperly stored. The patients experienced incorrect product storage as all of them received improperly stored RECOMBIVAX HB. No adverse effects were reported. No product quality complaint (PQC) was involved. Outcome of the event incorrect product storage was unknown. Reporter considered the event incorrect product storage to be not related to RECOMBIVAX HB. This is one of several reports received from the same source (MARRS # 1502USA001980). Additional information has been requested.