chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st dose 23 oct 2020, 2nd never received; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 23 October 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose 23 oct 2020, 2nd never received). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 27-MAR-2023 The pharmacist reported that a patient never received the second dose.  The pharmacist stated that the consumer intended to receive the second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination  The reporter consented to follow up. The details provided corresponded to the 1st dose as the case contained incomplete course of vaccination as the event.
Patient was given vaccine and soon after began having shooting pain down her arm. She believed the vaccine was given too high (was given slightly higher than usual). She continued to have pain down her arm throughout the next day, so she contacted her PCP. She was prescribed a prednisone taper to help with the pain, which she said was helping.
shivering; developed feeling hot; developed nausea; This case was reported by a consumer and described the occurrence of shivering in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th December 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 8th December 2020, 1 days after receiving Shingrix, the patient experienced shivering, feeling hot and nausea. On 8th December 2020, the outcome of the shivering, feeling hot and nausea were recovered/resolved.   It was unknown if the reporter considered the shivering, feeling hot and nausea to be related to Shingrix.  Additional details were provided as follows: The reporter stated that her husband received dose of Shingrix on left arm. The reporter stated the patient developed shivering, feeling hot, nausea.  The reporter consented to follow up also consented follow up to health care professional (HCP). This case is linked to the case US2020245647, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020245647:same reporter
Received Moderna vaccines on 12/31/20, 1/28/21 per report, vaccine lot #s not listed in chart. Tested positive for COVID-19 by PCR on 7/29/21. Admitted to Hospital/Clinic on 7/29/21 w/ 2 wks of increasing cough, SOB. In ICU for one day. Treating with Remdesivir.
Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 71 years old female patient who was vaccinated with a dose of FLUZONE HIGH DOSE instead of PNEUMOVAX 23 on an unspecified date. Patient was also vaccinated with FLUAD vaccine on an unspecified date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to extra dose administered and wrong vaccine administered (patient intended to receive PNEUMOVAX 23, but administered FLUZONE HD). It was reported that, the patient had no reactions. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
PATIENT COMPLAINED OF NAUSEA AND WAS COUGHING.  PATIENT DRANK WATER AND OBSERVED.
Rash-abdomen/ thorax (erythematous macular papular diffusely over thorax/ abdomen). No fevers.  follow-up 2/11/2010 - information has been received from a nurse practitioner concerning a caucasian female child. recently diagnosed with carnitine deficiency and probable mitochondrial defect. who was vaccinated subcutaneously in the right thigh, with 0.5 ml on 29 dec 2006 with her first dose of measles virus vaccine live, + mumps virus vaccine. live  + rubella virus vaccine live, varicella virus vaccine live (oka/merck upgrade process) (lot # 656308/3392f). on that same day, at 6pm, the child developed three poxes near the injection site noted to be a varicella-like injection site reaction. these poxes went away after a few days. two weeks later, on approximately 12 jan 2007, the patient developed four to five poxs on various locations on her body. the patient recovered on 19 jan 2007. no laboratory or diagnostic studies were performed. unspecified medical attention was sought. there was no product quality complaint involved.
Patient received multiple vaccines on 09/13/2004.  Denies significant local reaction at vaccine sites.  Denies significant fever, chills, headaches, myalgias, arthralgias, or fatigue the first several days following vaccine receipt.  Approximately 2 days after vaccine receipt, patient noted lesions appearing on arms (left first, then right).  Before the lesions appeared, the area was pruiritic, then a red, slightly swollen bump appeared - kind of looked like a pimple and had a black dot in the center; within a few days, the lesion would dry out, scab and peel and become ashy appearing.  Initially, the lesions were limited to his upper extremities until after he received his second anthrax vaccine on 10/07/2004.  About 3-4 days later, he noted a flat, round appearing, red lesion, about the size of a quarter on his left inner thigh.  Multiple lesions have appeared since then on his legs, trunk, flank and back.  He has been applying steroid cream (Lidex) which seems to help them clear.  Patient recalls developing similar appearing lesions after serving in the first Gulf War in 1991.  The lesions eventually completely resolved without recurrence.  He was given 10% disability for a skin condition, but extensive evaluation or a specific diagnosis was never made.  He does not recall, and there is no record of him receiving the anthrax vaccine during the first Gulf War.  He denies any other history of skin diseases such as eczema or psoriasis.  He denies a family history of skin diseases.
Onset of nose pain that resulted in uncontrollable nasal fluid at unexpected times. THe extreme nose pain continues to date.  No Doctor can figure why.   Lack of smell and taste also occurred..  Myeloperoxidase blood test revealed elevated blood inflamation count.  Norm is Approx. 135,  on Dec. 2021 I was at 1700. Next test in Feb. 2022 showed it was at 2200.  Next test in May 2022 showed 3,100!  I had (I think) every test that could be given to try and find the cause of this blood inflamation.  MRI of head, scans of sinus', teeth and gums.  Diet was explored.  Last test in Dec. 2022 showed 2,100.  I am currently taking a Statin drug to  try to  reduce the inflamation in my blood.  Cont. below My Ear, Nose, Throat Specialist cannot figure what's wrong with my nose and sinus'
Non medically substantiated report received from a male pt, who experienced pains in joints (knees, ankles and elbows) after receiving Fluvirin. Pain reported as often being quite severe. Pt's wife also experienced an adverse event after receiving Fluvirin. This case is linked to MPU-2000-00089. No further details reported. Follow up report received from doctor. Male pt (DCT, 60 years old, 77Kg, 175cm) experienced pain in joints-ankles, wrists, knees, shoulders (onset 3-4 weeks), cold sores inside nose and clicking of all joints after receiving single dose of Fluvirin IM. No previous flu vaccinations. Pain in joints not resolved. Outcome of other AE's unknown. AE reported to be incapacitating. No cattarrh-no cold/flu symptoms as reported. Medical history insignificant. No concomitant medication. Causal relationship as per reporter is probable. Further follow up received from pt. Pt reports that the pains he has been experiencing have eased considerably, though some tenderness is still present in the ankles. A follow-up report from a health professional was received on 8/19/02. The 60 year old male pt experienced pain in ankles, knees, wrists, and shoulders, clicking joints and had cold sores inside the nose, which was considered to be incapacitating, approximately three to four weeks after receiving a Fluvirin vaccine on 10/19/99. The pt did not experience cold or flu symptoms. At the time of reporting the pt had yet recovered. The reporter has assessed the relation of study medication to the event as probable.
Initial report received from a non-healthcare professional (receptionist) on 29 January 2013. A 25-year-old female patient received an intradermal first dose of FLUZONE ID (lot number unknown, anatomical site of administration was not reported) on 29 January 2013. The patient was 7 weeks pregnant at the time of vaccination. The reporter had no information regarding patient's pregnancy. The patient's last menstrual period date was unknown and estimated delivery date was not reported. The patient's concomitant medications were not reported. Laboratory data was not reported. As of 29 January 2013, the patient had not experienced any adverse event. Follow up information received from a healthcare professional on 01 July 2013: The patient had received FLUZONE intradermal (batch number: UT4466AA) in Left deltoid. The patient had experienced redness, swelling and warmth at the site of injectio on an unspecified date. Outcome of the injection site reaction was not reported. The patient had no previous pregnancies. The patient had no illness at time of vaccination and had not received any drug during pregnancy or prior to fertilization that could remain at the time of fertilization.  The patient had no pregnancy complications or family history of congenital abnormality. The patient's last menstrual period date was 12 December 2012 and expected date of delivery was reported as 18 September 2013. Prenatal test data was not provided as it was not at the reporter's clinic. The father's age was reported as 26 years and he had no significant medical conditions. List of documents held by the sender: None.
having gas/bloating since receiving the vaccine; This is a spontaneous report from a non-contactable consumer (patient).  A 50-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on 06Jan2021 at 10:30 AM at a single dose on the right arm for COVID-19 immunization. The patient was vaccinated in the nursing home/senior living facility. The patient was not administered any other vaccine in four weeks. The patient's medical history was not reported. Concomitant medication included levothyroxine (manufacturer unknown), vitamin d (manufacturer unknown), zinc (manufacturer unknown), Claritin (unspecified generic name) and unspecified vitamins. The patient previously took amoxicillin and experienced allergies. It was reported that the patient has been having gas/bloating since receiving the vaccine on 07Jan2021 at 16:00 (reported as 4:00 PM). The patient received over the counter gas medicine as treatment for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. The outcome of the event was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Complaining of pain and slight localized swelling at injection site, 5 minutes, post vax. Warm compress applied. Checked per RN,FPNP and told to alternate hot and cole compresses and call clinic in the morning. No SOB, itching or other complaints. Remained in clinic x 30 minutes.
Her upper lip felt tingly and swelled a little. Then next day a rash on her chest that itched which lasted several days then the itch stopped but the rash is still there 2 weeks later.
Patient started to develop spots/rash on the back of her neck at the hairline within about 24 hours from the vaccine. The rash was like little red dots and not a large red area of skin.  It continued to develop/not get any better so she went to see Dr. her regular doctor. From what the MD thought it was not related to the vaccine and instead prescribed her medication for a scabies infection. Patient did have a rental car for the time overlapping with the vaccination.
This medically confirmed spontaneous report (initial receipt 28-OCT-2014) concerns a 53 year old male patient. On 26-OCT-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-OCT-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time.  On 27-OCT-2014, the patient received temperature excursion AFLURIA (batch number: T50507) via intramuscular route at 0.5 ml. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling throughout the body), SKIN BURNING SENSATION (Burning throughout the body), NEURALGIA (Nerve pain throughout the body), DIZZINESS (dizziness) and PAIN IN EXTREMITY (Pain in her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   No medical history was reported by the reporter.     On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PARAESTHESIA (tingling throughout the body), SKIN BURNING SENSATION (Burning throughout the body), NEURALGIA (Nerve pain throughout the body), DIZZINESS (dizziness), PAIN IN EXTREMITY (Pain in her arm), PAIN IN EXTREMITY (Pain in legs), HEADACHE (headache) and MYALGIA (Muscle pain throught the body). The patient was treated with IBUPROFEN for Headache and Dizziness, at an unspecified dose and frequency. On 25-Mar-2021, DIZZINESS (dizziness), PAIN IN EXTREMITY (Pain in her arm), PAIN IN EXTREMITY (Pain in legs) and HEADACHE (headache) had resolved. At the time of the report, PARAESTHESIA (tingling throughout the body), SKIN BURNING SENSATION (Burning throughout the body), NEURALGIA (Nerve pain throughout the body) and MYALGIA (Muscle pain throught the body) 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. Treatment medication included ibuprofen.
On 12/14/99, the pt began to display symptoms  of herpes zoster. On 12/17/99, the pt was seen by a physician who confirmed herpes zoster. Additional information has been requested.
After 5 days of vaccination, welts appeared on both legs, with a very high level of itching. They kept showing up for another 3 or 4 days. Relieved itching within 4-5 days. As of today (3 weeks after injection) hardly any itching anymore, but skin lesions are still visible.
After 2nd COVID-19 vaccine shot on April 16, 2021 felt within 5 minutes like heat across my back/scapula regionfrom injection site.  Did not feel this with 1st shot.; Within 2 days noticed"spot" on my arm, NOT A RASHnear injection site that looked to be aswirl mark from internal burn. At onset, spot was a bit itchy.; Lymph nodes were still swollen inarmpits and what felt like left sideneck.; However when this spot is squeezedor massaged, there seems to beresidual pain on left side as if at theactual injection point,into neck, back of head and and intothe back around scapula.; At onset, spot was a bit itchy.; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 16Apr2021 at 13:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included anemia. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient was unaware of any known allergies to medications, food, or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 26Mar2021 at 13:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021, after 2nd COVID-19 vaccine, the patient felt within 5 minutes like heat across her back/scapula region from injection site. She did not feel this with 1st shot. Within 2 days noticed "spot" on her arm, not a rash near injection site that looked to be a swirl mark from internal burn. At onset, spot was a bit itchy. Lymph nodes were still swollen in armpits and what felt like left side neck. She noticed that the spot seemed to be "removable" perhaps not permanent due to when it was squeezed or massaged, it somewhat disappeared. However when this spot was squeezed or massaged, there seemed to be residual pain on left side as if at the actual injection point, into neck, back of head and and into the back around scapula. The patient questioned "Have you seen anything that looks like this? Photos can be made available". No therapeutic measures were taken as a result of these events. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event spot was a bit itchy at onset was recovered on an unknown date in Apr2021.  The clinical outcome of the events sensation of heat, spot like rash, swollen lymph nodes and vaccination site pain were not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Swollen lymph node in Left armpit.  No tenderness, swelling, reddness at injection site.  Came down with flu like symptoms on 10/26/2009-headache, sore throat, cough, fever.  Saw MD on 10/26/2009 and treated client for infection.  Started on Keflex for 10 days.  Client recovered with no problems.  According to mother, MD not certain in flu vaccination was cause but thought it should be reported.
This spontaneous report was received from a pharmacist via company representative and refers to a female patient of unknown age. The patient's concurrent conditions, past medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, strength, dose number, vaccination site, route, # lot, expiry date unspecified). A few months later, the patient experienced shingles (date unspecified). The patient sought the medical attention (unspecified). Product quality complaint was not reported. The outcome of shingles was unknown. Causality assessment was not provided. No additional information was provided. This is one of two reports received from the same reporter. Additional information has been requested.
suspected vaccination failure; flu; This case was reported by a other health professional via sales rep and described the occurrence of suspected vaccination failure in an unknown number of patients who received Flu Seasonal QIV Dresden (Fluarix Tetra) for prophylaxis.   On an unknown date, the patient received Fluarix Tetra at an unknown dose. On an unknown date, unknown after receiving Fluarix Tetra, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Fluarix Tetra.  Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that in his experience patients had come down with the flu after being vaccinated with Fluarix. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and dose number were not provided. The reporter did not give permission for follow up.
Patient received shot at 12:30pm. Tingling and numbness of hands, legs, and feet started at 12:35pm. Patient waited to see if it would resolve/improve. By 2pm, patient reported getting worse. She was given 2 Benadryl to self administer. She took 1 25mg capsule, then within a couple of minutes reported shooting pain in her back. She went home to rest, felt the same around 4pm and was instructed to take the second Benadryl and/or some ibuprofen/Tylenol for the pain in back.
PARALYSIS FROM WAIST DOWN - ADMITTED TO HOSPITAL ON 2/7/11 - TRANSFERRED TO ANOTHER HOSPITAL 2/17/11 & DISCHARGED ON 4/15/11 - STILL PARALYZED WITH DX OF TRANSVERSE MYELITIS
It is itching; Redness about the size of a pear at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (It is itching) and VACCINATION SITE ERYTHEMA (Redness about the size of a pear at the injection site) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (It is itching) and VACCINATION SITE ERYTHEMA (Redness about the size of a pear at the injection site). At the time of the report, VACCINATION SITE PRURITUS (It is itching) and VACCINATION SITE ERYTHEMA (Redness about the size of a pear at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
If a person received dose 1 and contracts symptomatic covid subsequently; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (If a person received dose 1 and contracts symptomatic covid subsequently) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (If a person received dose 1 and contracts symptomatic covid subsequently). At the time of the report, COVID-19 (If a person received dose 1 and contracts symptomatic covid subsequently) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided No treatment information was provided.