chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Stroke; Lymphoma; Lymphoma; Severe demyelination of brain; Neurological disease; Minimal movement in left arm ad left leg; Can't get out of bed or walk without help; Can't get out of bed or walk without help; This case was reported by a other health professional and described the occurrence of stroke in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis and COVID 19 MRNA VACCINE MODERNA for prophylaxis.   Previously administered products included Moderna vaccine (received 1st dose on 15th February 2021).   On 5th May 2021, the patient received the 1st dose of Shingrix and Tdap Vaccine. On 15th March 2021, the patient received the 2nd dose of COVID 19 MRNA VACCINE MODERNA. In May 2021, less than 3 weeks after receiving Shingrix and Tdap Vaccine, the patient experienced stroke (serious criteria GSK medically significant), acute disseminated encephalomyelitis (serious criteria GSK medically significant), lymphoma (serious criteria GSK medically significant), demyelination (serious criteria GSK medically significant), neurological symptom, movements reduced, bedridden and walking difficulty. On an unknown date, the outcome of the stroke, acute disseminated encephalomyelitis, lymphoma, demyelination, neurological symptom, movements reduced, bedridden and walking difficulty were not recovered/not resolved.   It was unknown if the reporter considered the stroke, acute disseminated encephalomyelitis, lymphoma, demyelination, neurological symptom, movements reduced, bedridden and walking difficulty to be related to Shingrix and Tdap Vaccine.  Additional details were provided as follows: The reporter was an epidemiology lead. The age at vaccination was not reported. The reporter knew someone whose mother (patient) received the Moderna and Shingrix vaccines and in May 2021, less than 3 weeks after receiving Shingrix and Tdap Vaccine and between 1 and 3 months after receiving Moderna vaccine, the patient developed some neurological symptoms. The symptoms were observed in mid-May 2021 and worsened by the day.  The patient went to emergency room on 7th June and again on 14th June 2021.  Initial diagnosis on 14th June 2021 was stroke but at the time of reporting it was undiagnosed neurological disease with severe demyelination of the brain.  The patient experienced minimal movement in left arm and left leg and could not get out of bed or walk without help. This was reported to VAERS.  The patient's son was also told that, it was most likely acute disseminated encephalomyelitis but now another doctor suggested lymphoma. The patient's son said he had been chasing ghosts with the doctors he had been sending the patient to and could not get a clear diagnosis. The reporter was reaching out to GlaxoSmithKline but was not sure if needed to report this to global safety. It was unknown if the reporter considered the stroke, acute disseminated encephalomyelitis, lymphoma, demyelination, neurological symptom, movements reduced, bedridden and walking difficulty to be related to Moderna vaccine.
Patient states that she experienced symptoms of narcolepsy (fell asleep at table with head down and felt very fatigued) and paralysis (couldn't move lower extremities).  Lasted about 10 hours and resolved on own with no lasting symptoms.  Patient called clinic on 1/23 and did not seek medical attention during episode.
Patient states right arm became hard after receiving first dose of Pfizer and is still feels hard when she came in for her second dose. She states no pain.
Patient came to the pharmacy with parents stating he has swollen nodes under his armpit. The nodes are bigger compared to yesterday.
vaccination site pain; injected limb mobility decreased; Cannot hold anything; This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain, injected limb mobility decreased and muscle weakness. On an unknown date, the outcome of the injection site pain, injected limb mobility decreased and muscle weakness were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injected limb mobility decreased and muscle weakness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but the patient was 63 years old at the time of reporting. The patient received Shingrix on left arm. The patient experienced pain at the injection site for the past months since he was vaccinated. The pain was intense enough that he could not raise his arm up to his shoulder and could not hold anything in his left hand without dropping it. For tolerance of 2nd dose of Shingrix refer case US2019GSK081895.
Myalgia & Fever Narrative: Per supervisor report: "Received second dose on 3/15/2021. Reports fever, body aches"
red area is burning; red area is more painful; redarea is spreading from actual site; hot, hard swollen area of redness,1/2 to 1 inch below the vaccination spot; red area is itching; hard, swollen area of redness 1/2 to 1 inch below the vaccination spot spreading from actual site; pain at the injection arm; hot, hard swollen area of redness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SKIN BURNING SENSATION (red area is burning), PAIN (red area is more painful), ERYTHEMA (redarea is spreading from actual site), VACCINATION SITE WARMTH (hot, hard swollen area of redness,1/2 to 1 inch below the vaccination spot) and VACCINATION SITE PRURITUS (red area is itching) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced SKIN BURNING SENSATION (red area is burning), PAIN (red area is more painful), ERYTHEMA (redarea is spreading from actual site), VACCINATION SITE WARMTH (hot, hard swollen area of redness,1/2 to 1 inch below the vaccination spot), VACCINATION SITE PRURITUS (red area is itching), VACCINATION SITE INDURATION (hard, swollen area of redness 1/2 to 1 inch below the vaccination spot spreading from actual site), VACCINATION SITE PAIN (pain at the injection arm) and VACCINATION SITE SWELLING (hot, hard swollen area of redness). At the time of the report, SKIN BURNING SENSATION (red area is burning), PAIN (red area is more painful), ERYTHEMA (redarea is spreading from actual site), VACCINATION SITE WARMTH (hot, hard swollen area of redness,1/2 to 1 inch below the vaccination spot), VACCINATION SITE PRURITUS (red area is itching), VACCINATION SITE INDURATION (hard, swollen area of redness 1/2 to 1 inch below the vaccination spot spreading from actual site), VACCINATION SITE PAIN (pain at the injection arm) and VACCINATION SITE SWELLING (hot, hard swollen area of redness) outcome was unknown.            patient developed no symptoms after receiving the first shot. No concomitant medications were provided. Patient consulted Nurse practitioner and treated her symptoms with acetaminophen, applied ice, applied warm clot and took allergy medications as advised. Nurse Practitioner also prescribed Sulfa drug medication and suggested to start taking if , if the redness is not getting better, but according to the patient rash improved although the redness persist, has no symptoms of itching or burning pain.
First dose Back pain for three weeks.  Second dose back pain. Sever joint Pain, stiffness and cracking. Pain to put pressure feet and hands. Warm feeling in hands and feet. When the aching went away started severe throbbing pain hands and feet. Overall warm feverish feeling in body. Facial tingling feeling off and on. After three weeks from second shot I went to my GP. She did bloodwork and put me on oral steroids for three days to try to ease pain in joints. Bloodwork was fine. GP believes I have ongoing reaction to vaccine
Patient was administered an expired vaccine. He experienced no side effects or problems. Pharmacist contacted him by phone to inform him of the event and reached out to Merck for guidance. Merck provided additional stability data that supported the expired lot as still being active/safe as long as storage conditions had been maintained. Pharmacist confirmed that storage of vaccine has been maintained properly. Given the information provided by Merck the pharmacist determined the patient did not need to be revaccinated.
Product deemed to be ineffective due to refrigeration issue. Manufacturer contacted. Patient notified and advised for re-administration of the dose.
Heart mermer lasting 3 days.  physician noted that if it get worse, go to the ER.
HYPOXIA 1/18/2022 TRAUMATIC SUBDURAL HEMATOMA, INIT HYPOXIA 1/18/2022 SEIZURE, UNSPECIFIED HYPOXIA 1/18/2022 SEIZURE, UNSPECIFIED
foot started bothering her a little bit and everyday it was getting worse; foot started bothering her a little bit and everyday it was getting worse; peroneal tendonitis; This is a spontaneous report from a contactable consumer for mother. An 85-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 14Jan2021 at single dose for COVID-19 immunisation. Medical history included the patient was having a foot issue that she has previously had in the past.  The patient's concomitant medications were not reported. The patient had her first dose of the Covid-19 vaccine on 14Jan2021. She was due for the second injection 04Feb2021.She got her vaccine on 14Jan2021 and on 15Jan2021 her foot started hurting. She was having a foot issue that she has previously had in the past. A doctor injected her "today" with a steroid called Kenalog. She has problems with her feet already. She has had this problem with the other foot.  Her foot started bothering her a little bit and everyday it was getting worse. She took her to a foot doctor and the doctor gave her a injection of the steroid Kenalog into her foot for peroneal tendonitis.  The reporter wanted to find out if the shot her mother has received due to pain in the foot would affect the efficacy of the Covid vaccine. The outcome was not recovered.  Information on the lot/batch number has been requested.
Very painful adverse effects; This case was reported by a other health professional via interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The patient experienced very painful adverse effects.
Information has been received from a nurse practitioner concerning a 16 year old female patient with no pertinent medical history and no known drug allergies who on 26-AUG-2008 and 09-APR-2009 was vaccinated IM with the first (lot# 660557/0072X) and second (661846/1312X) 0.5 ml doses of GARDASIL. Concomitant therapy included ORTHO TRI-CYCLEN. On 09-APR-2009 the patient experienced numbness and weakness on her left side, arm and leg (the same side that she received GARDASIL) after receiving her second dose of GARDASIL. The nurse practitioner mentioned the patient did not have any difficulties following the first dose of GARDASIL. After the second the patient reported having "difficulty moving her left leg" on the evening the dose was administered. The dose was administered in the left arm. The difficulty moving her left leg resolved the following morning upon rising for the day. The patient did not seek medical attention at the time of the adverse experience. No diagnostic laboratory test was performed. On unspecified date, the patient recovered. Additional information has been requested.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 01/02/21pfizer,Lot#EL0142 2nd 01/23/21dosePfizer,Lot#EL9262 Diagnosed covid positive:08/02/21 Symptom onset:07/29/21 Exposure:unknown Symptoms:cough,fatigue,Loss of smell/taste, runny nose.
Had explosive diarrhea x 10 - in BR x 45 min. Needed IV hydration (1L) Extreme abdominal cramping. Symptoms improved after 4 hrs with BENTYL-weakness x 2 days.
Patient had received his vaccination and was waiting for 15 minutes. Patient was shopping in pharmacy area and began to feel warm, flush, and light headed. Patient laid himself down and this was noticed by an associate. Code white was announced and 911 called. Pt was responsive and pharmacist applied cold compress to pt. EMS arrived and took over. Pt seemed fine after a few minutes of EMS arriving.  Pt did state during the event that this has happened to him before in the past.
1JUN pt vaxed; 2JUN numerous welts appeared on pt; no fever; 5JUN pt well;
Patient on HD, admitted with headache and blurred vision, followed by seizure on 10/15 (PRES), leading to hospital admission and subsequent ICU admission.
Information has been received from a pharmacist referring to an unspecified 60 year old patient of unknown gender. Medical history of the patient was not reported. On an unspecified date the patient was inadvertently administered (Merck) PROQUAD (lot#, dose, route and frequency not reported) instead of ZOSTAVAX (Wrong vaccine administered). No adverse effect was reported. No further information was provided. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB, (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information had been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share.  Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 4 months old patient of unknown gender. On 03-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported), lot#J016188, expiration date: 02-OCT-2016 that was improperly stored. No adverse effects were reported.  This is one of several reports received from the same reporter. Additional information is not expected.
Within a minute of giving injection in rt deltoid, pt experienced pallor, syncope, rolling back of the eyes followed by jerky movements of upper & lower extremities. After 5 seconds, she became responsive, but disoriented to place. Pt stated that she had not eaten much all day.
testing positive for COVID after receiving vaccine; testing positive for COVID after receiving vaccine; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar event for 14 patients. This is 8th of 14 reports.   An elderly patient (more than 65 years old) of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 at single dose for covid-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient experienced testing positive for COVID after receiving vaccine on 21Jan2021 with outcome of unknown. It was reported that 8 patients and 6 workers at a long term care facility were vaccinated on 13Jan2021 and reported testing positive for COVID on 21Jan2021. Since they were testing positive, physician wanted to administer bamlanirimab. The event resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.,Linked Report(s) : US-PFIZER INC-2021063794 same reporter/drug/event, different patient.
Feeling sweaty, ear ringing, light-headed, nausea, pins and needles after sitting back up in chest. Vital Signs: BP 96/60 HR 63 Resp 16 O2Sat 97%  Skin Signs: Clammy, Other - Pale  Circulation: Cap refill <2sec  Respiratory: Breath sound clear bilaterally  Repeat BP 120/85 Repeat HR 83 Resp 16 O2Sat 99%  Skin Signs: Warm and dry  Circulation: Cap refill <2sec  Respiratory: Breath sound clear bilaterally  Initial Treatment: Given water, laid down, patient said they felt fine after laying down, vitals returned to what patient said was normal for him. Hx of previous similar symptoms with blood drawn in past.  Follow up Treatment: Monitor x30 min  Notes: Patient was stable. Home with mom
Told by private doctor in day prior to vaccination it was okay to get the flu vaccine. Legs weak 10/11 pm, worse 10/12-hospitalized. 10/12, couldn't walk. 10/13 Did CAT, MRS, CSF. Doctor Dx as Guillain-Barr syndrome. Due to rapid onset of symptoms, doctors do not feel it's related to flu vaccine. Being treated for colon cancer. Had a virus sev. weeks earlier.  Per 60 day follow up: It is unknown if the pt has recovered.. Pt's phone is disconnected. Follow up on 6/2004: No information reported.
Spotty rash all over my torso. It started as one spot on my stomach for maybe a week that got progressively larger (now the size of at least a quarter) and then small spots spread all over, mainly on my chest.
Dehydration, fatigue, exacerbation of post-concussive syndrome, elevated CK, headache
Vomiting and Diarrhea started about 2 hours after getting vaccine; nausea lasted about 4 days; breathing difficulties started about the same time as the vomiting, but stopped after about 30 minutes.
A physician reported that an infant rec'd an injection of Prevnar on 9/27/01. That same day, the child developed swelling at the injection site. On 9/29/01, he was seen by the physician who noted that the child had developed a 5cm by 13cm area of erythema and induration at the injection site. The child recovered. This is 1 of 4 pt's from this facility who had an adverse experience following receipt of Prevnar lot 481-817.
Received another Moderna dose two days later; A spontaneous report was received from a consumer regarding his wife, an 81-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and then accidentally got the dose again two days later/inappropriate schedule of vaccine.  The patient's medical history included Alzheimer's Disease. Concomitant medications were reported as unknown Alzheimer's drugs.   On 17 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.    On 19 Jan 2021, the husband reported that the patient wandered off and received a second dose. Lot number for second dose reported as 013L20A.  Treatment information was not provided.   Action taken with mRNA-1273 was not applicable.  The outcome of the events, patient accidentally received the first dose twice, is reported as resolved.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot number 013L20A for second dose) with no associated AEs reported.
After receiving the vaccination, I couldn't move my head without feeling nauseous. This feeling lasted for 30 days. It affected everything that I did. My potassium dropped and that is why I ended up in the hospital. This sickness made it to where I couldn't eat or do anything. I also experienced severe chest pain. At the hospital, they checked my potassium and it was low. They gave me Phenergan for nausea and prescription for more. I followed up with my doctor and my potassium was still low, so we upped my dosage. As of today, I'm constantly feeling massively fatigued. I've started having down/depressed days. After receiving the vaccine, I am completely down and feeling awful.
Liver pain; Kidney pain; Feeling unwell; Headache; Hard arm / body aches/arm pain/hurt her arm; Fatigue; Joint pain; Feeling unwell/ disgust; Sweats; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Feeling unwell/ disgust), HYPERHIDROSIS (Sweats), HEPATIC PAIN (Liver pain), RENAL PAIN (Kidney pain) and MALAISE (Feeling unwell) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cirrhosis of liver without mention of alcohol and Cancer. Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN, INSULIN, VITAMINA D3 and METOPROLOL for an unknown indication.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, the patient experienced VACCINATION COMPLICATION (Feeling unwell/ disgust), HYPERHIDROSIS (Sweats), HEADACHE (Headache), MYALGIA (Hard arm / body aches/arm pain/hurt her arm), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain). On 12-May-2021, the patient experienced HEPATIC PAIN (Liver pain), RENAL PAIN (Kidney pain) and MALAISE (Feeling unwell). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 200 mg. At the time of the report, VACCINATION COMPLICATION (Feeling unwell/ disgust), HYPERHIDROSIS (Sweats), HEPATIC PAIN (Liver pain), RENAL PAIN (Kidney pain), MALAISE (Feeling unwell), HEADACHE (Headache), MYALGIA (Hard arm / body aches/arm pain/hurt her arm), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD21-090181, MOD21-090182, US-MODERNATX, INC.-MOD-2021-128357 (E2B Linked Report).; Sender's Comments:  MOD21-090181:Rep same patient different MOD21-090182:Rep same patient different US-MODERNATX, INC.-MOD-2021-128357:Reporter's case
soreness and swelling of the arm at the injection site- rash that she developed 3 days earlier redness and swelling of 10 cm
fluarix was given instead of the intended pfizer.  this is patients second dose of flu for the season.  she feels alright, told pt to inform physician
This was 2nd Pfizer Shot/No side effects with 1st Bumps and large rashes all over the body/itching Have it sought dr at this time...OTC meds
Information has been received from a patient's mother concerning her 12 year old daughter with a history of injection site reactions who on 29-JAN-2008 was vaccinated intramuscularly with her first dose of Gardasil.  There was no concomitant medication.  On 29-JAN-2008 the patient experienced warmth and swelling at the injection site.  The patient's warmth and swelling at the injection site persisted.  The patient sought unspecified medical attention.  Additional information has been requested.