chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AEs; Expired vaccine VAQTA administered; This spontaneous report was received from a nurse concerning a patient of unknown age and gender.  The patient's pertinent medical history, drug allergies and reactions and concomitant medications were not provided.  On 11-JAN-2021, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) pre-filled syringe (lot # S036494 which has been verified to be a valid lot number, expiration date 09-JAN-2021) at a dose of 1.0 milliliter, intramuscularly as prophylaxis. No additional adverse events. No product quality complaint was filed. There were no previous temperature excursions. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S036494; expirationdate: 09-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
This spontaneous report as received from a physician refers to a 1 year old male patient. On 10-JAN-2014, the patient was vaccinated with a dose of PROQUAD (Merck) (route, dose and lot # not reported) and a dose of DTP (manufacturer unknown) route, dose and lot # not reported) at a separate injection site. On 11-JAN-2014, the patient was taken to the Emergency Room where he was treated for a febrile seizure and a temperature which spiked 103.7 degrees F. It was unspecified if the child was admitted to the Hospital, however he was stabilized and discharged. The outcome of febrile seizure was reported as recovered/resolved. Upon internal review febrile seizure was considered to be medically significant. Additional information is not expected.
At 12:50 am on 02/02/05, complained ears "hot"; rashy, splotchy, red and white over face, arms elbows and hips. Afebrile per mom. Called physician and was told to give Benadryl. Symptoms eased then patient said her throat was tight. 2:00 p.m. on 02/02/05, ok but says still feels tightness in throat.
Patient's daughter came to the pharmacy at 5:30PM  on 4/5/2018 and informed us patient died.
I was exposed to someone who tested positive the day before on Sunday. I woke up on May 2, 2022 with a sore throat, and it was painful. I went downstairs and used an at home test kit. It immediately turned positive for Covid. I put on a mask, and then I put my son on a mask. I called my doctor and she prescribed me with Paxlovid for a 5 day course of 3 pills 2 times a day. it helped with the sore throat. My symptoms were mild. I had a mild sore throat, a little congestion, and fatigue. On May 7, 2022 on a Saturday I tested negative. I am continuing to isolate until day 10. I have had greater fatigue in the last few days than earlier on. In the last few days I felt a lot of fatigue. When I go out and try doing anything I am exhausted.
Reynauds in bilateral fingers and toes. No previous experience with this. Painful discoloration in distal extremities.
Vaccine was diluted with 1.6 ml instead of 1.8 ml. No adverse reaction reported.
Case number PHHY2011US59051 is an initial spontaneous report received from a medical assistant on 30 Jun 2011. This report refers to a 17 year old male patient. He was vaccinated with MENVEO (batch number: A10032) intramuscularly on 30 Jun 2011. He received another dose of MENVEO (batch number: A10032) intramuscularly again by error on 30 Jun 2011. No adverse event was reported following this drug administration error.
On 7-18-07, DTaP vaccine was given instead of TDaP.
2/20/2007 received 1st injection of HPV vaccine only noticed pain at site of injection the first day. 2nd HPV vaccine received 4/3/2007--no pain until 4/10 began to notice and has progressed to today 'muscle hurting all the way around' pain level "10" on scale 1 to 10.
Case number PHEH2014US003655 is an initial spontaneous report from the nurse (also patient's mother) received on 21 FEB 2014. This report refers to a 15-year-old male patient who was accidentally vaccinated with FLUCELVAX 2013/2014 (batch number: not reported) intramuscularly on an unknown date in DEC 2013. No adverse event reported following this medication error (inappropriate age of vaccine administration).  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Swollen lymph nodes in neck; breast lump left breast; Cough; Congestion; Fatigue; Weakness; knee pain/pain in joints of healed injuries that were years old; Pain in index finger and right hand and wrist that is still present and Pain in Right big toe; Dizziness; Headache lasting a week; This is a spontaneous report from a contactable nurse, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 28May2021 at 12:45 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, graves' disease, penicillin allergy and it was reported that the patient had healed injuries that were years old and was injured over 2 years ago. Concomitant medications included vitamin b complex (B COMPLEX), propylthiouracil (PROPYLTHIURACIL), and rubus idaeus leaf, sambucus nigra flower, sambucus nigra fruit (ELDERBERRY) with zinc; from an unknown date for unknown indication and unknown if ongoing. The patient previously received methimazole (MANUFACTURER UNKNOWN) for unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28May2021 at 13:00, the patient experienced swollen lymph nodes in neck, breast lump left breast, cough, congestion, fatigue/weakness lasting 7 days, knee pain. Pain in joints of healed injuries that were years old. Pain in index finger and right hand and wrist that was still present. Pain in right big toe, was injured over 2 years ago. Headache lasting a week and dizziness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events swollen lymph nodes in neck, breast lump left breast, cough, congestion, knee pain/pain in joints of healed injuries that were years old, pain in index finger and right hand and wrist that was still present and pain in right big toe and dizziness were recovering at the time of this report. The clinical outcome of the events fatigue and weakness were recovered on 04Jun2021 while the event headache lasting a week was recovered on an unknown date in Jun2021.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Large rash (red), slightly swelling. Patient assistant, itching, and warmth. Dr. recommended taking extra ZYRTEC once a day for 3 days.
Fell to floor when getting out of recliner I could not get up. A neighbor came to my house and eventually was able to get me up (It was very hard). Unsteady for most of day
fast heart rate/Pulse rate increased; headache; muscle aches; chills; joint pain; slight fever; ached all over; This is a spontaneous report from a contactable Nurse (Patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date was not reported), via an unspecified route of administration on 18Mar2021 08:00 as DOE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date was not reported), via an unspecified route of administration on an unknown date as single dose for COVID-19 immunization. Patient stated that she received her 2nd dose on 18Mar2021, morning at 8 and didn't develop symptoms until after 5 pm. She had a fast heart rate, headache, muscle aches, chills, joint pain, and a slight fever. When she woke up twice during the night, she ached all over. She was in the 90s for her pulse rate and had a fever too. She drank something, went to bed and woke up again and was bounding. And today her pulse rate was 100-112. It did come down to the 80s. Patient also stated with Moderna's COVID vaccine, they're seeing up to weeks with a rapid pulse and was wondering if Pfizer's COVID vaccine was the same. The patient underwent lab tests and procedures which included heart rate: 90 on Mar2021 (I was in the 90s for my pulse rate), heart rate: 80 on Mar2021(It did come down to the 80s), heart rate: fast on Mar2021, heart rate: 100-112 on 18Mar2021 (today my pulse rate is 100-112). The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021307523 same reporter, different patient/drug/event
I was 5 weeks pregnant for my first shot and 8.5 weeks pregnant for my second. I found out I was pregnant with twins the week after my first shot at 6 weeks pregnant, but on the day of my second shot, a prenatal ultrasound found no fetal heartbeats in either fetus and determined pregnancy loss.
Patient received Pfizer 5-11 year old dose 1 day past BUD of 10 weeks.
Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were unknown. On unspecified dates, the patients were vaccinated with improperly stored ZOSTAVAX (dose, route, lot and expiration date unknown) for prophylaxis. The details of the storage were two occurrences when the temperature of the freezer reached 29 Fahrenheit degree for 30 minutes on each of the two occasions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted.; Sender's Comments: US-009507513-1612USA011816: US-009507513-1701USA001057:
Initial report received from a healthcare professional on 09-Oct-2013. Adults were administered given DAPTACEL instead of TDAP. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Patient states that top of arm is swollen and she has a fever. It start about and hour after the vaccination. She has been taking Tylenol
No additional AEs or PQC reported; Caller reported PROQUAD administered after a temperature excursion. No other information provided. No additional AEs or PQC reported. ? Names of vaccines involved (including lot/exp) PROQUAD W002781 7/24/2023 ? Temperature 8.4F; This spontaneous report was received from a nurse referring to a 10-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 11-APR-2022, the patient was vaccinated with improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) at a dose of 0.5 milliliter (ml), administered subcutaneously, in left deltoid, as prophylaxis (lot # W002781 has been verified to be a valid lot number measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date reported and establish as 24-JUL-2023; strength was not reported). In addition, on the same date, the patient received  HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe, in right deltoid, as prophylaxis (lot number U032681 has been verified to be a valid lot number measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date reported and establish as 26-OCT-2023; strength, vaccination scheme and route of administration were not reported).   The temperature was reported as 5.36 Fahrenheit (F). Additionally, it was reported that temperature and time frame of the excursion were as 8.4 F for 30 minutes respectively. Data logger was used and showed high temperature (product storage error). There was no previous temperature excursion. No additional adverse events were reported.        It was stated that no experience a previous temperature excursion.
30-60 min post injection, onset of pruritus and erythema in arm. Also noted slight induration. Resolved immediately upon 50 mg po dose of diphenhydramine.
Intermittent fussiness throughout the evening. Settled down, but started crying again later on.  Would not take bottle. Mother noticed red blotches on the abdomen which continued to arms, legs, face.  Described as hive-like. Went to ER around 12:30 - 1:00 am on 10-16-07.  Was given a dose of Benadryl. To follow-up with pediatrician in 2-3 days. No rash noted this am per mother's report.
Patient called on 11-9-13 saying she was shaking last night after receiving the pneumonia shot, and she had a fever. The fever and shakiness is gone today but now her arm is swollen and hot. She can't raise the arm where she received the shot.
Four days after her first shot she developed abdominal pain and diarrhea with fatigue.  This slowly improved until her second shot and the abdominal pain was worse with bloody diarrhea.  She went to the ER and was diagnosed with colitis
I have got my 1st Moderna shot on 03/19/2021 and 3 days after it noticed loud tinnitus, discomfort/pressure in my L ear. It?s still ongoing after six weeks. On 4/09/2021 my PCP prescribed Prednisone 40 mg for 5 days ? no improvement. Saw ENT doctor on 04/16/2021 and got confirmation that L ear is perfect and hearing is somewhat decreased on both sides according to age, no apparent reason for tinnitus. His recommendation was to use Flonase, stay observant and check for further symptoms. Unfortunately the ENT had no real answer for me. In case of continuation of tinnitus or worsening of condition he suggested to contact his office for an MRI. Have been using Flonase for 10 days without any improvement.
Pt arrives severely hypoxic from a residential facility and is not normally on oxygen. Pt admitted with acute respiratory failure with hypoxia and COVID-19.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date, the patient was vaccinated with GARDASIL 9 for prophylaxis. On an unknown date, the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL 9. Additional information has been requested. Sender's Comments: US-009507513-1708USA011860: US-009507513-1708USA008820: US-009507513-1708USA011859: US-009507513-1708USA011856: US-009507513-1708USA011857.
Redness at injection site at 2" x 2 1/2" itching (-) pain.
Received vaccines 9/12/06, experienced hives, headache and nausea this AM associated with Tmax 101.5F. Facial swelling with no face hives, hives on arms and legs. No Shortness of breath, wheeze or diarrhea.
SLEEPY; This spontaneous report received from a pharmacist concerned a 62 year old male. 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On 06-MAY-2021, Laboratory data included: COVID-19 antibody test (NR: not provided) Positive (units unspecified). On an unspecified date, the subject experienced sleepy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sleepy. This report was non-serious. This case, from the same reporter is linked to 20210519895.
Fatigue, Myalgia, Shortness of Breath, Fever, Diarrhea
Soreness and tenderness after shot; A spontaneous report was received from a male patient of unspecified age, who received Moderna's COVID-19 vaccine and experienced soreness and tenderness after shot/vaccination site tenderness.   The patient's medical history was not provided. No relevant concomitant medications were reported.    The patient had received high dose flu shot on left arm on an unspecified day in DEC-2020 (reported as 17 days ago)  On 14/Jan/2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) via unknown route in right arm for prophylaxis of COVID-19 infection.  In Jan/2021, after first dose of vaccine, the patient experienced soreness and tenderness after shot. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported..  The outcome of the event, soreness and tenderness after shot was resolving at the time of this report.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Heart rate increased; Feeling a little lightheaded; Tingling in nostrils and lips; Tingling in nostrils and lips; This is a spontaneous report from a contactable other-HCP. A 36-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 19Dec2020 (Saturday) at single dose for covid-19 immunization. The facility type vaccine was hospital. Medical history included obesity, Sleep apnea, seasonal allergy. The patient's concomitant medications were not reported. After receiving the vaccine, 15-20 minutes afterwards patient began having an increased heart rate, feeling a little lightheaded and they brought patient back into the room. They monitored his vitals and then he started having tingling in his nostrils and lips but his blood pressure was fine. He didn't have any throat closure or anything like that but they monitored him in the emergency department for approximately an hour or so and they let him go and gave him the medications. Patient didn't received any treatment. The outcome of the events was recovering. Patient took CMB and EMP test. Patient further stated he was just trying to figure out should he get the second dose or not of the vaccine.   Information about lot/batch number has been requested.
Had the "FLUVIRIN" flu vaccine and had a reaction. Redness at site, fever x 4 days, chills, fatigue.
Severe body aches, fever, headache, nausea, fever Treated with Motrin 28Oct21. Symptoms persist.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions or concomitant medications. On an unknown date, the patient was vaccinated with M-M-R II by intramuscular route (strength, dose, anatomical location, lot number and expiration date were not reported) for prophylaxis (incorrect route of drug administration).  No adverse symptoms were reported.
I felt OK for the first 3 days and then I started having worse symptoms of my MCAS and POTS condition.  Note, I had NOT had POTS symptoms for 7 years.  I was originally diagnosed with POTS in 2010 but slowly got better over 3 -4 years time and have not had issues with POTS since until after the 1st dose of the Covid 19 vaccine.  Once my mast cell issues seemed to improve after the first week or so then the POTS symptoms kept getting worse.  I am now one month out from the first shot and my heart rate and blood pressure are so bad I'm mostly couch ridden.  I'm seeing a cardiologist on Monday.  Heart rate even when sleeping at night is shooting up to 125-136 without exertion, just sleeping or standing.  I have almost passed out while driving 5 times.  Until I improve I won't be driving on major freeways.  My vision has also been severely effected.  Very blurry and one time all I could see were prisms blinding my view of almost everything.  Also very weak all of the time and a lot of pressure in my head, it feels like someone is pushing my head forward. Some ringing of the ears as well.
24AUG93 w/in 10 minutes of administering immun, large red edemous area appeared over each inject site, then hives appeared on red area of MMR site; VS stable; went to hosp ER-treated w/DPH;
left arm is still sore; sometimes itchy; was hard to move are in certain ways for a few days; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (left arm is still sore), PRURITUS (sometimes itchy) and MOBILITY DECREASED (was hard to move are in certain ways for a few days) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (left arm is still sore), PRURITUS (sometimes itchy) and MOBILITY DECREASED (was hard to move are in certain ways for a few days). At the time of the report, MYALGIA (left arm is still sore), PRURITUS (sometimes itchy) and MOBILITY DECREASED (was hard to move are in certain ways for a few days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Inflamed lymph nodes above left collarbone, same side as injection, appeared 1 week after shot.  Still present 3 weeks later, but are slowly reducing in size.
Pt. returned to clinic on 8/10/10. Was seen in ER on 8/7/10. DX: Cellulitis. Also sustained an injury from a catfish to hand & had cellulitis at hand site and around (L) thigh that had vaccines a few days earlier. Was put on KEFLEX and BACTRIM at ER - Followed up with Dr. on 8/10/10 with both sites cellulitis resolving.
significant right armpit lymph node swelling; fatigue; headache; lymph node swelling is quite large, painful and concerning; This is a spontaneous report from a non-contactable other hcp (patient). A non-pregnant 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EN6201, Expiration date were not reported), via an unspecified route of administration  administered in the right arm on 11Feb2021 00:15 (at the age of 46-years-old), as dose 2, single for COVID-19 immunisation. Medical history included Environmental allergies and topical product allergies in soaps and cosmetics but no medications. The patient had no concomitant medications. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EL8982, Expiration date were not reported), via an unspecified route of administration  administered in the right arm on 21Jan2021 00:00 (at the age of 46-years-old), as dose 1, single for COVID-19 immunization and experienced injection site rash. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient experienced significant right armpit lymph node swelling, fatigue, headache, and lymph node swelling is quite large, painful and concerning on 11Feb2021 19:00. No treatment was received as a result of the events. The outcome of events was not recovered.   No follow-up attempts are possible. No further information is expected.