chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received ROTATEQ plus DTAP plus ACTHIB plus Polio on 12/29/12, Intussusception Volvulus diagnosed 1/25/13.
it hurt (at site of injection) but it's worse today and it's spreading to shoulder; has upset stomach; has not eaten since yesterday afternoon; it hurt (at site of injection) but it's worse today/ her arm is  so sore; heart is racing even worse than usual; has 4 bumps around site of administration.; can't move arm away from body; had chills for 2 days; This case was reported by a consumer via call center representative and described the occurrence of atrial fibrillation aggravated in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   Previously administered products included COVID-19 vaccine (completed COVID-19 vaccine series before receiving 1st dose of Shingrix). Concurrent medical conditions included atrial fibrillation.   On 5th May 2021, the patient received the 1st dose of Shingrix (intramuscular) and PNEUMONIA VACCINE (intramuscular). On 5th May 2021, less than a day after receiving Shingrix, the patient experienced chills. On 6th May 2021, the patient experienced upset stomach, appetite absent and pain in arm. On 7th May 2021, the patient experienced shoulder pain. In May 2021, the patient experienced atrial fibrillation aggravated (serious criteria GSK medically significant), injection site swelling and injected limb mobility decreased. On an unknown date, the outcome of the atrial fibrillation aggravated, injection site swelling, upset stomach, appetite absent, pain in arm and shoulder pain were not recovered/not resolved and the outcome of the injected limb mobility decreased was unknown and the outcome of the chills was recovered/resolved.   It was unknown if the reporter considered the atrial fibrillation aggravated, injection site swelling, injected limb mobility decreased, chills, upset stomach, appetite absent, pain in arm and shoulder pain to be related to Shingrix.  Additional details were provided as follows: The patient reported case for herself. The patient received pneumonia shot at same time as the dose of Shingrix in right arm. The patient reported that her heart was racing even worse than usual. The patient has had chills for 2 days. The patient had upset stomach and had not eaten since afternoon of day before reporting. The patient reported that day before reporting it hurt (at site of injection) but it was worse on the day of reporting and it was spreading to shoulder. The patient could not move arm away from body, her arm was so sore. The patient had 4 bumps around site of administration. The reporter did not have batch number or expiry date of vaccine. The reporter did not consent to follow up. It was unknown if the reporter considered the atrial fibrillation aggravated, injection site swelling, injected limb mobility decreased, chills, upset stomach, appetite absent, pain in arm and shoulder pain to be related to pneumonia vaccine.
1 day p/vax pt devel fever of 103 & irritability;pt was treated symptomatically & recovered;this is 1 of 3 from this site to have adverse exp p/vax lot# 439192;
pt exp 5 hr episode of nonstop screaming & was given APAP on 2 occasions to no avail; seen in acute care clinic; exam @ that time revealed pt in no distress;
Woke up 1/1/10- muscular pain, entire body, drippy nose, fatigue, little appetite, lasted through 1/3/10. Has worn off since then. No swelling or redness at injection site. Patient took Acetaminophen.
patient reported increased swelling and pain at injection site day after receiving the second dose of moderna vaccine  followed by admission to hospital for 2 days with reported oxygen support.
Death within 24-48 hours of vaccinations. Mother found infant not breathing and with bleeding from his nose. He was in his crib. Mother called 911. EMT's transported infant to ER. Infant probably died prior to EMT's arrival per reporter. Autopsy report received on 11/29/2004 cause of death is SIDS. Pt also experienced bilateral pulmonary congestion and edema perimortem.  Nurse follow up on 10/13/04 states: "Blue in color, cardiac arrest."
Patient received ADACEL and ZOSTAVAX immunizations in her Left arm on 4/25/16. Patient called 5/10/16 and stated that her arm was sore where she received the ADACEL vaccine. The pain occured the following day, which is as expected with ADACEL. But the patient stated that the pain went away and then came back and still feels sore and was concerned that it was caused by the vaccine. I called her today to follow up and she stated that it is feeling a lot better and thinks that it was caused by something else besides the vaccine. And will follow up with her doctor next week if she feels the pain is still lingering.
doses administered past the 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    In February 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. vial was initially stored in the refrigerator on 14-jan-2022. Date(s) of administration of vaccine was 14Feb2022, 15Feb2022, 16Feb2022, 18Feb2022, 21Feb2022. Pharmacist reported that they gave 26 doses after the 30-day use by date.  No treatment information was provided
Narrative: 75 y/o male with dementia presented to ER on 1/25/22 with weakness, falls, and worsening confusion. Increased cough and congestion. Darker urine and dry heaves but no vomiting earlier in the day. Tested positive for COVID. Treated with remdesivir and dexamethasone. Patient died on 2/3/2022. Cause of death likely due to progression of COVID vs treatment medications. PMH of hypertension, dementia, diabetes, atrial fibrillation on apixaban, aortic dissection, and hyperlipidemia.
Lethargic; 103.8 fever; Passed out; Arm twitching. He woke up in the morning with these symptoms and was sent to the ER. He was then admitted to the hospital. He stayed there overnight. He was given a 10 day course of antibiotics. He was diagnosed with possible pneumonia of the right middle lobe. He will go back to the doctor on 01/04/2022 as well.
The rash started on or about 1-21-2017. Pt is concerned b/c he thinks he may have had a reaction to the Zoster vaccine. He presents with an itchy red raised rash to the trunk and lower bilateral arms. He thinks it started on his lip. The lip has resolved without any further involvement. He denies problems with chewing, swallowing, or breathing. He has not started any new medications or foods. Red raised coalescing rash to chest and, back and upper arms. Sparing the legs and face. There are a couple raised semicircular lines (welts vs scratch marks). Allergic rash c/w drug rash. Pt. will take OTC CLARITIN or ALLERGRA and BENADRYL. Skin rash. Zoster vaccine.
No adverse reaction note from the 1st dose of Moderna. Patient reported having antibody therapy for COVID on 1/13 and 1/14. Patient received 1st dose of Moderna on 2/10/21. Patient presented to the clinic for the 2nd dose on 3/10/21. Consulted with provider who recommended delaying 2nd dose until 90 days after monoclonal antibody therapy. 2nd dose has been scheduled for 4/19/21.
A week after vaccine the shot site swelled up, got hot, turned red, and caused pain. We took pt. in to be seen and were told this is normal and it needed to run it course.  Now 6/09 pt. has developed a rash on her neck, trunk, and arms.
L arm muscle achiness, mild fatigue, mild headache- completely resolved 36 hrs after administration. No treatment.
Pt. c/o erythema of face with mild edema, tingling in hands and "funny" sensation in mouth and throat. Denies SOB, itching, hives. Redness in face noted prior to flu shot, slight anxiety noted. BP 120/80 at 10:30 AM. Given BENADRYL 50mg PO at 10:32 AM. at 11:00 AM pt. called friend to dive her home. Called RN 1 hour later to report improvement in symptoms. Advised to call PCP or go to ER if symptoms return.
5 x 3 cm splotchy erythema at right lateral proximal thigh with ~ 1.5 cm area of erythema.  Vomiting after each breast feeding 7/13/2022 and 7/14/2022.
soreness; redness; itchiness; sometimes arm hurts; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness), ERYTHEMA (redness), PRURITUS (itchiness) and PAIN IN EXTREMITY (sometimes arm hurts) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced PAIN (soreness), ERYTHEMA (redness), PRURITUS (itchiness) and PAIN IN EXTREMITY (sometimes arm hurts). At the time of the report, PAIN (soreness), ERYTHEMA (redness), PRURITUS (itchiness) and PAIN IN EXTREMITY (sometimes arm hurts) had not resolved.            Concomitant medications were not provided.  Patient is not taking any treatment medications for the events.
4 hours after admin of SHINGLES vaccine, felt rapid heartbeat, pulse suddenly over 170, dizziness, weakness. Home BP monitor (Omron HEM711AC) read "error" for first 20 minutes. With legs raised, I finally got readings between 87/65 and 90/70, pulse 145. Called my doctor, who recommended ambulance to emergency. EMT administered medication via IV, with almost immediate effect reducing pulse to 105 and raising BP to normal range. Further medication in hospital. Fully recovered by 2 a.m. Possible factor: One Latte 10 a.m., 1.5 cups coffee 3 p.m.
Patient had Varicella shot on June 24th 2004 and 4 days ago has had Varicella like rash in the area of immunization.  Erythema, fine crusted scab in the left arm,  Diagnose: Adverse effect to Varicella Vaccine  Plan: Warm Compresses prn and Tylenol
Nontender, swollen anterior and posterior cervicle nodes, began the evening vaccine administered, enlarged over 203 days, have remained same size for past 2 days. (+) Dysphagia, neck with FROM, no headaches. Largest node 3x4cm, post 2x4cm.
Fever/chills, body aches, headache, generalized malaise; pain at injection site
A medical assistant reported that a 58 year old female received an injection of Pnu-Imune 23 on 09/14/00. Within a few hours of vaccine administration, she developed an injection site reaction characterized by heat, redness, pain, and swelling. It was also reported that this patient had received a dose of Pnu-Imune 23 on 10/20/94. This is 1 of 3 patients from this facility who had an adverse experienced following receipt of Pnu-Imune 23 lot 463-015. Follow-up info received from the physician on 03/06/01, indicated that the patient recovered.
Soreness and swelling of arm starting about two hours after shot. Fever, aches, tired, headache starting around 3:30 a.m night of shot  Fever and tiredness is gone two days after.  Arm still sore.
Patient received vaccine beyond 30 days on the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine beyond 30 days on the fridge) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine beyond 30 days on the fridge). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine beyond 30 days on the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  A part-time Pharmacist called 30SEP2021 to report that expired doses of the Moderna vaccine was administered to 25 patients. The vials were in refrigerator for over 30 days.  Number of doses/vials - 27SEP2021 1 vials of 14 doses, 29SEP2021, 1 vial, 11 doses Date the vial was initially stored in the refrigerator: 24AUG2021 Date(s) of administration of vaccine, 27SEP2021 and 29SEP2021   This case was linked to MOD-2021-338604 (Patient Link).
06/22/21 noticed red marks everywhere no irritation at first skin peeling/ bought calamine lotion and cream/improving rash condition skin
some soreness at injection site; sleepiness; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced some soreness at injection site, sleepiness. patient also reported she experienced some soreness at injection site lasting for 2-3 days and sleepiness after she received her first covid vaccine (vaccine manufacturer not clarified with caller). Seriousness reported as non-serious. The outcome of event was unknown.  Information on the batch/lot number has been requested.  Follow-up attempts are completed. No further information is expected.
This is an instance of breakthrough COVID-19 disease after which death occurred.   The individual was vaccinated with the Moderna product on 03/08/2021 and 04/05/2021. They became symptomatic for COVID-19 disease on 08/10/2021 and tested positive for COVID-10 via PCR on 08/16/2021. They were admitted to hospital on 08/27/2021 and were diagnosed with COVID-19 pneumonia. They remained hospitalized until their death on 08/29/2021.
I got Pfizer covid vaccine (first shot) on April 9th and have been suffering from prickling (pins and needle) on my body. This prickling happened randomly anywhere in my body (feet, arms, chest, all over the place of the body) and happened frequently everyday since I the second day I received the vaccine.    It is six week now since I got the vaccine, but pins and needle feeling still haul over me. I search online and found there are hundreds of people complaining about the same side effect I had. Some even say that this pins and needle feeling persist for months. I am not sure whether this pins and needle feeling eventually goes away. and I hope someone looks into this side effect and give us some guidance since there is no official document talks about this side effect.
Fibrilation; low blood pressure; heart rate not controlled; Injection site pain; achy all over; This case was reported by a consumer via call center representative and described the occurrence of fibrillation in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included fibrillation. Previously administered products included Shingrix with an associated reaction of pain (1st dose received 2 to 3 months before the time of reporting, refer case US2019AMR141015).   On 30th July 2019, the patient received the 2nd dose of Shingrix (intramuscular). In July 2019, 14 hrs after receiving Shingrix, the patient experienced general body pain. On 30th July 2019, the patient experienced injection site pain. On 31st July 2019, the patient experienced fibrillation (serious criteria GSK medically significant), low blood pressure and heart rate irregular. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fibrillation, general body pain, injection site pain, low blood pressure and heart rate irregular were unknown.   It was unknown if the reporter considered the fibrillation, general body pain, injection site pain, low blood pressure and heart rate irregular to be related to Shingrix.  Additional case details were reported as follows: The patient a dose of Shingrix on the right arm at the pharmacy. Immediately after vaccination, the patient experienced injection site pain. The next day, 14 hours after vaccination, the patient experienced achiness all over.  On the same day, around 2 PM, the patient noted she was experiencing fibrillation and low blood pressure of about 70/50.   The patient went to the emergency room and the blood pressure and heart rate could not be controlled.   The patient had cardioversion.   The patient was discharged. The reporter did not consent to follow up.
Mother states child developed symptoms of itchy nose. Itchy throat, sniffing, swollen left cheek area. when 1 1/2-2 hrs after vaccinations. Left eye area red. No rash, no Sob, no swelling. Treated with Benadryl 3x times, resolved about 4 hrs later.
Immediate taste of an antibiotic in mouth,  numbing of lips and tongue within 3 minutes of vaccine.  Slight swelling on right side of face. Reported to primary physician and referred to  neurologist. Second dose was canceled.
Patient came into the Immunization Clinic  and stated that ever since he had his FluMist on 10/13/2010 he has had a very dry mouth, dry lips, and slight tenderness on his tongue and gums.  Pt. states this started the day after the FluMist was administered. Patient was screened using the 2010-2011 military Seasonal Flu questionaire.  Patient was administered FluMist on 10/13/2010 in a group flu line after all questions were reviewed with the screener.  Patient has a history of hyperlipidemia and is on Lipitor 20 mgm by mouth every day.  Patient states he had an abnormal 24 hour Urine and Chem Screen when he saw his provider on 10/22/2010.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving doses after its beyond use date) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 022J21A) for COVID-19 vaccination. No Medical History information was reported. On 10-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving doses after its beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (receiving doses after its beyond use date) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. It was reported that 3 doses from different vials were used and no temperature excursions. It was reported that the vial was initially stored in the refrigerator on 11-Jan- 2022 and beyond use date for that was  11-Feb-2022. It was reported that the vial undergo any temperature excursions reported None. No concomitant medication was reported. No treatment medication was reported. This case was linked to MOD-2022-573737 (Patient Link).
Fever (103+) for 3.5 days, malaise, vomiting for 1 day.
Edema, mild erythema on right lateral thigh. Mom came to check this but doctor visit not required.
Patient developed redness, swelling , pain, limping within 122 days of receiving flu vaccine. Swelling, erythema, tenderness, pain resolved after starting clindamycin for treatment of cellulitis.
It happened a week after the shot, it was a sore throat; stuffy nose; runny nose and arm pain. And a cough, too. I had those symptoms about two weeks. No treatment.
Soreness to Left arm lasted for 48 hrs Fatigue started 12 hrs after and lasted for 36 hrs
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 18-FEB-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml, (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 804 hours with the lowest recorded temperature of -3 Fahrenheit degree. The total cumulative excursion time of the second time was 336 hours with the highest recorded temperature of 59 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
9 days p/MMR devel occiptal & cervical lymphadenopathy & fatigue so far lasting 2 days;
Per mother child developed hives on arms and legs and fever - up to 102 about 1 hour after receiving vaccine on 6/9/14. Evaluated by ARNP today - rash and fever continues.
Information has been received from a physician concerning a 27 year old female office personnel member with latex allergy and no medical history who in middle March 2010 (on approximately 15-MAR-2010), was vaccinated with the first dose of GARDASIL (lot # not reported). There was no concomitant therapy. On approximately 15-MAR-2010 the patient experienced general itching (not at the injection site) after receiving the first dose of GARDASIL (lot # not reported), and 10 days later (on approximately 25-MAR-2010), she went into anaphylactic shock. It was reported that the patient was given prednisone for a few days, and recovered completely about two to three weeks later (in 2010). On an unspecified date, the patient had a test in allergist's office (the result not reported). In May 2010, the patient was vaccinated with the second dose of GARDASIL (lot # not reported). On an unspecified date in May 2010 the patient experienced a sore throat and similar itching symptoms but did not go into anaphylactic shock after administration of the second dose of GARDASIL (lot # not reported). It was reported that the patient had discontinued the dosing schedule due to the reaction. At the time of reporting, the outcomes of sore throat and similar itching symptoms were unknown. The patient sought unspecified medical attention. Anaphylactic shock, general itching, sore throat and similar itching symptoms were considered to be immediately life-threatening by the reporter. Additional information has been requested.
DIZZINESS, SWELLING OF FACE AND NECK, SEVERE 24/7 HEADACHES, LACK OF FOCUS, SEIZURE LIKE SYMPTOMS, FAINTING, MUSCLE TWITCHING AND JERKING, NAUSEA.
Received vaccination about 2:30. About 7:30 PM started having scratchy throat and watery eyes. Woke up at 2:30 AM with violent diarrhea and vomiting.
A week after injection, my arm started itching and then swelled up in a circle the size of a silver dollar and about 1/2" high. Still inflamed, red and itchy on 8th day.  Coated with Benadryl extra strength cream to combat itchiness.
Patient had erythema, slight swelling, increased warmth at injection site on left upper arm.