chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine stored in freezer temperature too long.  We recommended to the patient to get revaccinated.
On 3/31/22 it was discovered that the patient has received two doses of Pneumovax 23. One dose was given on 12/5/20 and the other dose was given on 12/28/21. I have tried to reach out to the patient and had to leave a message. As far as we know there were no adverse events for receiving the same vaccine twice. We will update when we talk to the patient.
Approximately 15 minutes post vaccine being given, she complained of dizziness. "Like a fish bowl effect." She was placed on vs monitor. BP 151/103, HR 80, O2sat 99%. 11:25am She stated she was feeling better. BP 141/94, HR 75, O2 sat 100%, 11:35am She stood up from chair, stated dizziness was gone. BP 148/82, HR 77, O2 sat 100%. She remained alert and oriented x3. She left vaccine clinic ambulatory with steady gait.  3:25pm She came back to vaccine clinic ambulatory, c/o feeling shaky, dizzy, warm, flushed, general malaise, jittery. Her vs were monitored 136/100, 93, O2 sat 100%. 3:45pm She was transported to Emergency Department via wheel chair. She remained alert and oriented x3. VS upon leaving vaccine clinic, 159/106, 80, O2sat 99%.  1/5/21 Followed up with her via phone conversation. She stated her BP was ok in the Emergency Department. They were unable to get blood work from her. She was work on 1/5/21.
Back pain and nerve pain started soon after second vaccine. Hip pain started late and continued to decline. Numbness and tingling with pins and needles feelings in feet, legs and hands. Patient had difficulty walking and breathing that got worse and went to the hospital on 08/23/2021. She had no fever and the hospital did a scan and it came back clear. Her body was burning and she developed a persistent mouth thrush with swelling of her tongue. She went to the hospital five different times since the incident without getting better. She has an appointment with a neurologist in a month.
Approximately 10 minutes after receiving the second dose of the Pfizer Covid-19 vaccine, patient began coughing. Patient reported throat tingling and itching that spread to her face as well. Patient reported a severe headache as well.
Fatigue, nausea, reduced appetite, recurrent fever, lasting just over one month.
The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 1-year-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the vaccines hepatitis a vaccine, inactivated(VAQTA) (lot # S019435 with expiration date 23-AUG-2020, lot # S026003 with expiration date 17-OCT-2020, and lot # S032056 with expiration date 09-NOV-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) 25/0.5 dosage form at a dose of 0.5 ml (route not provided) for prophylaxis. No adverse events were reported.  This is one of several cases from the same reporter.  combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S019435; expirationdate: 23-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004521: US-009507513-2005USA004522: US-009507513-2005USA004523: US-009507513-2005USA004524: US-009507513-2005USA004526: US-009507513-2005USA004527: US-009507513-2005USA004528: US-009507513-2005USA004529: US-009507513-2005USA004530: US-009507513-2005USA004531: US-009507513-2005USA004532: US-009507513-2005USA004533: US-009507513-2005USA004534: US-009507513-2005USA004535: US-009507513-2005USA004536:
29MAR94 1AM t101; no other sx APAP administered every 4 hrs; no localized react 29MAR94-12noon; t101 cont APAP; 29MAR94 730PM sz taken to hosp t105.4 in ER; Motrin administered; dx as ear infect; 31MAR93 cold sx;
Felt very good for 5 or 6 hours after injection. Left arm had became sore and stiff by 5:00 .  By 6:15 PM slight nausea, fatigue, body aches and chills.  By 7:30 or 8:00 PM experienced extreme chills, fever, and more intense body aches all over - especially sore and stiff left arm.  Also slight nausea and loose stools.  After feeling well enough to find the thermometer, temp registered at 100.5, and continued through night. The chills were intense. Treated fever with liquids and rest.  Fever and chills lasted until about 9:00 AM 1/27/2021.  I was able to eat a little, then very fatigued and slept until 4:00 PM 1/27/2021. After a light dinner, slept all night. Woke 1/28/2021 better, but not energetic.  As of today, 1/29/2021, I am able to return to normal activities.
Rash and urticaria pruritus. Prednisone 10 mg other.
This spontaneous report was received from patient's wife, a healthcare worker refers to a male patient of an unknown age. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 dose 1, intramuscularly (lot number, expiry date and dosage not reported). On an unknown date, the patient developed heart conditions, it was reported that, an unspecified physician "who recognized history of heart conditions" suggested a second "protective" dose of PNEUMOVAX 23 which was administered at an unspecified time in 2008. No adverse effects reported from second dose of PNEUMOVAX 23. No product quality complaint was involved. The outcome of the event was unknown. The reporter did not provide any causality assessment between event and PNEUMOVAX 23. No further information provided. This case is linked to case #1603USA007174 via same reporter link. Additional information has been requested.
Pt recvd 2 doses of Hep B vax 1st dose was w/REcombivax?, 2nd dose booster given w/Engerix-B titers p/1mo indicated the pt to be a non-responder;
Information has been received from a physician concerning a female age "14 or 15 years old" who on an unspecified date was vaccinated with the first dose of 0.5 ml of GARDASIL. After vaccination, the patient felt faint. It was reported that the patient felt dizzy, had difficulty breathing (also reported as "had a short of breath feeling"), felt like her throat was closing and looked tense. Her lungs were clear, there was no wheezing, no signs or symptoms of swelling, no facial or eye swelling and her blood pressure was stable. The physician reported that she thought this looked like a "slight reaction." The patient was given diphenhydramine hydrochloride (BENADRYL) as a precaution. The physician reported that the events were resolving that same day. It was reported that the patient "experienced similar symptoms not relating to vaccines and felt the symptoms may have been more panic driven than anything else." At the time of this report, the patient had recovered from the events (date unknown). The physician reported that she did not feel that the treatment with diphenhydramine hydrochloride (BENADRYL) was needed to prevent serious criteria and did not feel that this experience was life-threatening to the patient. Additional information has been requested.
Patient received MENVEO and IPOL on the left arm on April 16, 2018 at clinic. Patient requested both vaccines on same arm. Patient had received 3 prior doses of IPOL, but she had never received a dose of MENVEO. Patient reports some pain with injection but no other symptoms. On April 17, 2018, the patient showed a family member where she got her shots, and they noticed that the administration site was reddened and swollen and warm to the touch. She checked it through the evening, and it continued to stay that way. On April 18, 2018, a family member brought in the patient at 2:00 pm for a check. Upon assessment, the left upper arm is reddened and swollen.  There is a defined place on the upper arm that is almost round in shape. The patient also complains of being tired. The patient denies any other complaints. Advised the patient to treat with cool compresses at the site as needed. Advised the patient to use Benadryl, per package instructions, as needed for allergic reaction. Advised the patient's family member that if condition worsens or patient has any trouble breathing to take patient to PCP, Urgent Care or ER. Patient and family member voiced understanding and had no further questions.
Expired Vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. DA2L2OA, 022M20A and 038B321A) for COVID-19 vaccination.     The patient's past medical history included Osteopenia, Chronic renal insufficiency, Thrombocytosis, Weight loss, Wrist pain (Wrist pain, right), Hypothyroidism, GERD, Edema (Edema, ankle left), Loss of taste, Anosmia, Polymyalgia rheumatica, Leukocytosis, Anemia, Wrist pain, Skin cancer, Cardiomyopathy, Cough, Cellulitis, Cholecystitis, Pancreatitis, Congestive heart failure, Arthralgia, Lung cancer, Lumbar radiculopathy (Lumbar radiculopathy, RIGHT), Sciatica (Sciatica, RIGHT), Skin cancer, Rotator cuff syndrome (Rotator cuff syndrome, left), Claudication, Knee pain, Sick sinus syndrome, Sinus bradycardia, Aortic stenosis, Prostate cancer (SCREENING FOR PROSTATE CANCER), Vitamin D (VITAMIN D, DEFICINECY), Tongue disorder, Dyspnea, Lumbar sprain, Atrial flutter, BPH, Coronary artery disease, Melanoma, High cholesterol and Cholecystectomy. Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE on 10-Feb-2018, INFLUENZA VACCINE on 21-Oct-2019, INFLUENZA VACCINE on 18-Sep-2020, INFLUENZA VACCINE on 14-Sep-2021 and INFLUENZA VACCINE on 14-Sep-2021. Past adverse reactions to the above products included No adverse event with INFLUENZA VACCINE, INFLUENZA VACCINE, INFLUENZA VACCINE, INFLUENZA VACCINE and INFLUENZA VACCINE. Concomitant products included VITAMIN D3, CYANOCOBALAMIN (VITAMIN B-12), CARVEDILOL, SPIRONOLACTONE, APIXABAN (ELIQUIS), SACUBITRIL, VALSARTAN (ENTRESTO), FUROSEMIDE, TAMSULOSIN HCL, ROSUVASTATIN CALCIUM (ROSUVASTATIN CALCIUM GENERIC), PANTOPRAZOLE, IPRATROPIUM BROMIDE, LEVOTHYROXINE SODIUM and PREDNISONE for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used). On 28-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information not provided.  Treatment information not provided.
Received injections for school Monday 8/2/02. Mother states initial slight edema, redness over DTaP site on left arm (deltoid). By Tuesday, afternoon/evening, mother states left arm medial to DTaP injection site very warm/hot to touch and red, tender to touch. Telephone call to local physician Wednesday morning and instructed to use warm wet packs over site. Mother also called health department after speaking with physician. Telephone call to mother same afternoon for follow up. Swelling (fist size) and remains hot, red. Encouraged to notify doctor. Started on Cephalexin. Telephone call 8/5/04 with less swelling and redness.
Myalgia, fatigue Narrative: Severe muscle pain and fatigue 5/27/2021 resulting in unable to work 5/7/2021.
About two and a half months after the vaccination I woke up with my feet burning. After about a month of dealing with the pain I decided to see see a neurologist and was diagnosed with Peripheral Neuropathy. I'm now prescribed to take Gabapentin 600mg daily, Duloxetine 120 mg daily, Magnesium 500mg daily, Toradol 20 mg at prn, Lipitor 10mg daily.
Rash over torso, lasted approximately 36 hours, accompanied by extreme itching on torso
pt recvd vax in OCT93 & lab eval revealed anti-HBs neg & pos anti-HBc; MD felt that the pos core result may have been a lab error; No further details were provided;
About 7 minutes after patient had the shot, we were standing at the receptionist's area and she fainted and fell down.  She remembers getting very dizzy and seeing black dots, but doesn't remember falling.  She was awake by the time she was on the floor.  We let her lie down, then she was able to walk into a room, and just sat, had water, and we were able to leave about 15 minutes later.  Once at home, her head hurt from the fall, she rested, and seemed much better.  At night, around 10 pm, she felt slightly nauseous, but then went to sleep for the night.
weakness; dizziness; This is a spontaneous report from a contactable consumer (patient's wife). A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Apr2021 01:30 as single dose for covid-19 immunisation. Medical history included diabetes. The patient's concomitant medications were not reported.  The patient had started to feel weakness and dizziness on 20Apr2021. The outcomes of events were unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient visited pharmacy on 3/31/21 for second Shingrix vaccine. I went to administer vaccine in left deltoid and patient stopped me to let me know I was injecting in wrong location. After prompting, patient stated that the pharmacist who administered her first dose gave it to her subcutaneously.
My symptoms rebounded after taking Paxlovid for COVID infection; This spontaneous case was reported by a patient and describes the occurrence of SYMPTOM RECURRENCE (My symptoms rebounded after taking Paxlovid for COVID infection) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Multiple sclerosis and Allergy (Unknown historical drug).   On 08-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SYMPTOM RECURRENCE (My symptoms rebounded after taking Paxlovid for COVID infection). At the time of the report, SYMPTOM RECURRENCE (My symptoms rebounded after taking Paxlovid for COVID infection) was resolving.            Patient race was reported. No concomitant medication information was provided.  The patient was not taking any other medicationsproducts(unspecified) within 2 weeks of starting COVID-19 treatment.  No treatment medication were provided.
4 hours after vaccine became very cold and shaky. Stumbling gait. Hyperventilating due to shaking. Seizure activity - clonic. Loss of appetite. Cough.
c/p pain, in R upper arm extending to R shoulder, r proximal forearm starting morning after vaccination
Information has been received from a pharmacist referring to unspecified numbers of patients with unknown age and gender. There was no information about the patients' medical history and concurrent condition. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (strength, dose, lot# and route unknown). There was no information about concomitant therapy. No adverse effects were reported. this is one of several reports received from the same reporter. Additional information has been requested.
DIED; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 14-APR-2021, the patient died due to unknown cause. An autopsy was not performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210429218 - COVID-19 VACCINE AD26.COV2.S- Died. This event is considered Unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Information has been received from a health professional concerning an 83 year old female who in approximately November 2006 was vaccinated with a dose of Varivax instead of a dose of Zostavax. The medical assistant reported that this was "office staff error only". The patient did not experience any adverse events post vaccination. Additional information has been requested.
Information has been received from a physician concerning a 22 year old female who on an unspecified date was vaccinated with a first dose of Gardasil vaccine. On an unspecified date within a week after the Gardasil vaccine was administered to the patient, the patient experienced an "inguinal lymph node." Medical attention was sought. The physician reported that the patient's lymph node is still swollen. No further information was provided. Additional information has been requested.
Booster - Painful, red spot appeared two days after vaccine.  Lasted a week.  Then turned into a red, itchy rash with welts and swelling and prickly.  Continued to spread for a week over upper left arm, shoulder, collar bone, down chest, other areas popped out such as middle and side of left torso, left wrist, left shoulder blade and under arm pit.  Topical treatment of cortisone and benedry didn't help.  Doctor prescribed Prednisone 20 mg/day for 7 days.  Greatly improved the situation. 2nd Vaccine - Vascular issues developed about a month after vaccine and continued for several months which included rapid heart rate, irregular beats, busted eye vessels, swollen in vein in calf.
After receiving the second dose of Moderna vaccine, patient felt nauseous, lightheaded and very weak then passed out. Patient was back in few seconds and declined 911 call. Patient was provided with Gatorade and Pedialyte to get some electrolytes. Patient was under pharmacist observation for 45 minutes. Her BP was checked 20 minutes after the shot was administered, which was 105/61. Patient confirmed history of dizziness but no history of low BP. Patient felt nauseous again and almost passed out and again declined 911. Her BP was checked again, it was 103/59. At this point pharmacist recommended her to take some more electrolytes to ensure she is hydrated and to see if her BP is due to dehydration. Final BP was checked 45 minutes after getting the shot. Patient was hydrated and alert and her BP when measured was 124/85. Patient was stable when left for home with her husband.
Had vaccine at 1:30 p.m. Thursday, March 25. 11:00 p.m. Sunday, March 28: Chills, fever 100.5, sweating, body aches and general malaise. Lasted approx. 12 hours. Recurred 10:30 p.m. Thursday, April 1; again evening of Sunday, April 4; again around midnight Thursday, April 7. April 7 episode did not end as rapidly .... on Friday, April 8, fever intensified to high of 103.2 before I traveled to hospital emergency room where I was admitted and am still a patient as of this writing (9:00 a.m. Wednesday, April 14). No fevers since Sunday; probably will be released today. Several blood cultures completed; no infections. Doctors scratching their heads. Am scheduled for second Pfizer dose tomorrow, April 15, at 5:00 p.m. and am very nervous about it but doctors are recommending I take it.
Seizure experienced on same day as immunization. Note - patient taking TRILEPTAL 600 mg BID for seizure control.
Patient called 8/20/2022 to say she developed a few itchy red bumps on right leg. 1 on lower leg behind right knee and 2 or 3 on upper right leg.
stinging in the lt area of the chest; pain in the lt deltoid w/edema & redness of the lat arm; high fever & dizziness; pt said had numbness of the total lt side & it cont w/numbness of the arm; chills;
Bruising/ In the area where he got he vaccine he has bruising the size of a silver dollar; The muscle to the left of the injection site would not relax; Report knot in arm; This is a spontaneous report from a contactable consumer (patient). A 38-Years-Old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot number: not reported),via an unspecified route of administration on Apr2021 as single dose for covid-19 immunisation. Medical history included I get sick when the weather changes. The patient's concomitant medications were not reported. It was reported that particular side effect site 4 days ago. Bruising. Healthy.  Norovirus. Two days ago he was doing one arm lateral lifts. He can do 40.  Normally he can do that every day.  Left arm.  Muscles don't want to loosen up. 25lbs.  At the injection site. 250 lbs.  Don't need weight. Patient  haven't had a vaccine since 18 years. His body automatically adapts. He get sick when the weather changes. Report knot in arm. It was reported that when the caller was doing lateral lifts with 25 pound weights, his muscle started to ball up in that area and he has bruising at the injection site all on left side. The patient clarifies the details provided from the CEP agent. The patient was vaccinated 4 days ago, maybe 3 days ago, with his first dose of the covid vaccine. The caller was doing one arm lateral lifts with 25 pound weights, and he usually does 35 to 40 pound weights, he was taking it easy. Normally the patient can do that every day with no problem. In the area where the caller got the vaccine, he has bruising the size of a silver dollar. The muscle to the left of the injection site would not relax, the muscle now fights the caller when he tries to use it. The muscles in the patient's left arm have all relaxed, except for that one. Patient explained the effects of the vaccine. From how the patient understands it, vaccines hijack the muscle that they are in and make crowns. It could mean that its hijacking the muscle and corrupting the cells in the patient's arm muscle which is causing this but he is unsure because he is not a doctor. Patient asked is this normal for the muscle to not want to relax. How long will this last. The patient received his second dose of the covid vaccine a couple of days ago. When the patient was doing lateral lifts with 25 pound weights, his muscle started to ball up in that area and he has bruising at the injection site all on left side. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.