chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2009, the patient was inoculated with the ZOSTAVAX vaccine by physician as recommended for routine adult health maintenance for the long term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 13-NOV-2014, the patient was treated by a physician for severe vesicular rash, which was diagnosed as herpes zoster. The patient was prescribed valacyclovir and hydrocodone for management of her painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
After the second shot, it really got worse. Hers is not muscles; it's more joints.; Her joints swelled up - feet, hands, ankles; Her joints swelled up - feet, hands, ankles; This is a spontaneous report from a contactable consumer (reporting on behalf of his daughter). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history was not reported and concomitant medications was none. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. After the first shot, the patient experienced her joints and muscles hurt. After the second shot, it really got worse. Hers was not muscles; it was more on the joints. Her joints swelled up, feet, hands, ankles. The reporter's doctor put her on steroid pills, and within the next day, all her symptoms went away. After she got off the steroids, everything came back just the way it was. The events were considered as non-serious by the reporter. The outcome of the events was recovered on an unspecified date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Swollen lips; Swollen tongue; Swollen face; Itchy throat; Lightheaded; weak; feeling Sore on right arm; This is a spontaneous report from a contactable consumer, the patient. A 27-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/Batch no: EN 6204) via an unspecified route of administration in right arm on 12Mar2021 at 08:45 AM (at the age of 27-years) as a single dose for COVID-19 immunization. Medical history included allergy to sulfa drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to vaccination. On 12Mar2021, post the vaccination, the patient felt soreness on the right arm. On 13Mar2021 at 12.00 PM, he started to become very weak, and light headed. On 14Mar2021, he woke up and his entire face was swollen including his tongue and his throat was itchy and on 17Mar2021, his lips and tongue were still swollen. Therapeutic measures included treatment with methylprednisolone acetate (DEPO-MEDROL) 40 mg/ml injection. The clinical outcome of the events vaccination site pain, weakness, light headedness, swollen face, swollen tongue, swollen lips, and itchy throat was reported as not resolved.  No follow-up attempts are needed. No further information is expected.
Patient states she had extreme muscle pains from head to toe but injection site itself was ok. Pain lasted for few days.
This spontaneous report as received from a physician via company representative concerning to a 10 month old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with ROTATEQ by oral route of administration for prevention of rotavirus (dose, lot number and expiration date were not reported). On an unknown date, the patient was hospitalized "for an unknown number of days" and was diagnosed with intussusception. The patient received an unspecified treatment and eventually recovered from the event. The causal relationship between the event and therapy with ROTATEQ was not reported and no product quality complaint was involved. Upon internal review the event intussusception was considered to be medically significant.
Swelling and redness at injection site, hard bump where injection occurred, severe headache, nausea, diarrhea, slight fever, and brain fog
Dizzy; fatigue; chills; aches; fever; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, on 15Apr2021 at 4:00 PM (Batch/Lot number was not reported) at the age of 63-years-old, as a single dose in the left arm for COVID-19 immunisation.  Medical history included low thyroid and allergies to penicillin, both from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, unknown lot number), dose 1 on 25Mar2021 at 4:00 PM at the age of 63-years-old as a single dose in the left arm for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient experienced dizzy, fatigue, aches, fever and chills on 16Apr2021 at 12:00 PM. The reported adverse events resulted in emergency room/department or urgent care. Treatment received included fluids and test run to rule out any other problems. The patient had no COVID prior vaccination. The patient was tested for COVID post vaccination which was a nasal swab with negative result on 16Apr2021. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
MMR (R) thigh SQ J003785 3/28/15 Merck. Rash over body. Around eyes and body 10 days past vaccination. Seen in ER 01/18/14 FU at office 1/20/14. Normal MMR rash not MMR Ds.
Tinnitus worsened severely, leading to several weeks of insomnia and adverse mental health effects (anxiety/depression)
body aches, chills, right arm pain and some swelling which is migrating to right axilla and right breast
Patient has not received her 2nd shot; Redness around the injection site; Pain soreness around the injection site; Dizzy; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient has not received her 2nd shot), DIZZINESS (Dizzy), VACCINATION SITE ERYTHEMA (Redness around the injection site) and VACCINATION SITE PAIN (Pain soreness around the injection site) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced DIZZINESS (Dizzy). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient has not received her 2nd shot), VACCINATION SITE ERYTHEMA (Redness around the injection site) and VACCINATION SITE PAIN (Pain soreness around the injection site). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient has not received her 2nd shot) had resolved and DIZZINESS (Dizzy), VACCINATION SITE ERYTHEMA (Redness around the injection site) and VACCINATION SITE PAIN (Pain soreness around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications details were provided. No Treatment Medications details were provided.
patient received 1st Moderna vaccine 3/12/21,  2nd Moderna  vaccine 04/09/2021,  admitted for cerebellar stroke on 04/16/2021
Severe headache everyday since injection, lightheaded, extreme fatigue, no appetite, vomiting, brain fog
no additional adverse events; Product storage error temperature too low; This spontaneous report was received from a licensed practical nurse and an office manager referring to a 7 months old female patient. The patient's pertinent medical history and drug reactions/ allergies were not reported. The concomitant medication and historical vaccine was reported as none.     The unit that had vaccine was making a noise. To prevent a loss of vaccine, all vaccine transformed to a unit that had intrinsic samples in it on 09-APR-2021. Due to the amount of product in the unit, the temperature got down to 35.2 Fahrenheit (F) for 480 hours and 0 minutes on one day. On 30-APR-2021, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (the third dose, 2 ml, lot# 1707457, expiration date 23-FEB-2022, orally for prophylaxis; strength was not provided), haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot# TF4EB is an invalid lot number, expiration date 26-SEP-2021, intramuscularly (IM) on left anterior thigh (LAT) for prophylaxis; strength was not reported), hib vaccine conj (tet tox) (HIBERIX) (dose, strength, route, indication, anatomical location, lot# and expiration date were not reported) and pneumococcal vaccine conj 13v (crm197) (PREVENAR 13) (lot# DN4217, expiration date 30-DEC-2022, intramuscularly on right anterior thigh (RAT); dose, strength and indication were not reported were not reported) and diphtheria vaccine toxoid (+) hepatitis b vaccine rhbsag (yeast) (+) pertussis vaccine acellular 3-component (+) polio vaccine inact 3v (vero) (+) tetanus vaccine toxoid (PEDIARIX) (lot# 4977T, expiration date 05-SEP-2022, intramuscularly on LAT; dose, strength and indication were not reported were not reported). There was no previous temperature excursion. A digital data logger was involved. When a new unit was available and temperature at acceptable level, vaccine was put in the new unit on 04-MAY-2021. The vaccine was not available for return due to single use. No additional adverse events reported.; Sender's Comments:  US-009507513-2105USA002859:
difficulty breathing/shortness of breath/tightness in lungs starting 6PM of 1/8 and lasting until 1/11 at 7AM. No other asthma triggers present.  I did ski 1/8/21 with no breathing difficulties andgiven presistent tightness I thought waiting in lift lines could have resulted in covid exposure.  Continued breathing difficulty not responding to albuterol finally caused me to get a covid test 1/10/21, which was negative. Breahting returned to normal by moringing of 1/11/21.
Diagnosed by husband (a physician) as acute inflammatory arthritis secondary to HBV.  Also seeing another physician.  Patient placed on Prednisone for seven days, felt better for several days.  Now back on Predisone as of 6/23/2005 due to pain in all fronts
redness & sl swelling of rt arm pt said felt fine, no nausea, SOB, weakness or dizziness;MD recommended DPH;pt fine p/20min then left & ambe back 20min later w/swelling, redness;later seen by MD w/SOB given med;
About 3d after shot, patient was at gym and noticed L arm had decreased strength and decreased grip strength. No improvement since. Now has noticed some intermittent L hand tremors and L leg weakness. This was all disclosed when patient returned for shot #2. Shot #2 not given. Patient advised to discuss with PCP first.
Received shot 3/2/07-very sore within an hour-swollen, hot, tender within an hour-stayed swollen hot, sore-20cm for 5 days. Then gradually subsided. No fever, chills, malaise, lymphadenopathy, joint pain, other skin no other symptoms.
I felt a little discomfort in my left arm in the morning when I got up, 0900.  By 1200, I was having some chills so I added a sweater.  By 13:30, I was having more violent chills, so I grabbed a blanket and increased the room temperature.  By 15:00 my fever was approximately 100 and then by 15:45 it was 102.  I called my PCP and they suggested acetomediphine.  I took two pills at 16:10 with some water and am waiting for my fever to go away it reduce.
Patient is a 94 Y female with history of hypertension, HFpEF, seizure, left eye blindness, Covid19 (+) 12/20/2022.    Recently admitted 2/6 - 2/16/2023 for melena.  EGD on 2/6/2023 - severe esophagitis, type 1 hiatal hernia, 4 duodenal ulcers.  2) anemia due to GI bleed s/p total of 2 units prbc, 3) bacteremia - blood cultures 1/2 sets collect 2/6 +Eubacterium lentum, ruminococcus gnavus, clostridium species.  Pt was discharged home with Protonix and Vantin/Flagyl to complete 2 weeks of antibiotics.   Covid19 swab (-) on 2/6/2023. Reported pt has already developed some mild cough during last hospitalization.     Patient was sent to the ED when home health RN checked o2 sat = 81% and pt appeared to have some shortness of breath.
pt recvd vax JUL89 & devel hives & welts w/bluish/purple scarring on hands & feet; No further details were provided;
Today about 1:00 she got a meningitis booster (required for her to go to college). At about 4:00 she started feeling bad and laid down in the floor. She got up went to lay down.  At 6:20 she came out to say she feels sick like she?s going to throw up and pass out and her skin is achy to the touch. (She also started her period today.) She is pale. Has a headache. Her jaw hurts. Her body looks as if she?s shivering).
Expired dose administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2022-2023 season) (batch number NS775, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd September 2022, the patient received Fluarix Tetra 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. On 22nd September 2022, unknown after receiving Fluarix Tetra 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-SEP-2022 Reporter's comment: The nurse reported that a dose of Fluarix Tetra given to the patient and it was already expired. The reporter consented to follow up. Additional Supportive Information: The use of Fluarix Tetra dose which was already expired on 30th June 2022, which led to expired vaccine used.
Strong abdominal contractions started roughly 48 hours after injection. These contractions were about 20 minutes apart and lasted for 24 hours.
One week (approximately 7.5 days) after my first injection (in my left arm) of the Moderna COVID vaccine, I noticed a large, swollen, red lump at the injection site at bedtime. No pain, but a lot of itching and warm to the touch. The next morning/this morning, my left armpit is tender and somewhat achy.
ear ringing" since the 1st day she got the shot; She states that she did not hear any noise until she got "the stupid vaccine."; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 52 year-old patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "ear ringing" since the 1st day she got the shot"; HYPOACUSIS (non-serious), outcome "unknown", described as "She states that she did not hear any noise until she got "the stupid vaccine.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (Fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030AZIA and 021BZIA) for COVID-19 vaccination.     The patient's past medical history included Flu (Patient had flu vaccine 1975.). Concurrent medical conditions included Allergy to antibiotic (Patient is allergic to doxycycline.), Allergy to antibiotic (Patient is allergic to Levaquin) and Food allergy. Concomitant products included ROSUVASTATIN and SIMVASTATIN for High cholesterol, COLECALCIFEROL (VITAMIN D 3), MAGNESIUM, ZINC PICOLINATE and CURCUMIN for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced CHILLS (Chills). On 16-Mar-2021, the patient experienced PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. At the time of the report, CHILLS (Chills) and PYREXIA (Fever) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Nov-2020, SARS-CoV-2 antibody test: positive (Positive) Positive. Patient had swab in nose test..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.Patient did not receive any treatment.   This case was linked to MOD-2021-126299 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: Follow-up information received on 11-MAY-2021.Added patient demographics,past history,Lot no of suspect drug, concamitant drugs.
Patient given first dose of Jynneos intradermally in left forearm on 09/28/22. During the patient's appointment for second dose on 10/26/22, the patient's history of keloid scarring was discovered on a questionnaire. The patient reported their history of keloid scarring during the first appointment as well. Upon RN inspection of the patient's left forearm, no adverse reaction was present. Adverse reaction was also denied by the patient.
This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, batch/lot# unknown), at the age of 32, via an unspecified route of administration, on May 6, 2021, at 14:15, single dose, for COVID-19 immunisation. Medical history not reported. The patient allergic to peanuts. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included postnatal multivitamin since an unknown date for an unknown indication and unknown if ongoing. On May 7, 2021, patient experienced petechiae localized on abdomen (about one inch by two inches). The events did not result in doctor or other healthcare professional office, clinic visit/emergency room, department or urgent care. Therapeutic measures not taken as a result of the events petechiae localized on abdomen (about one inch by two inches). Since the vaccination, patient has not tested for COVID-19. The outcome of petechiae localized on abdomen: not resolved (at the time of report). No follow-up attempts required. Information about batch/lot number cannot be obtained. No further information expected.
Burning feeling at injection site immediately. Spread to fingers within one minute and lasted over 24 hours. Within two hours, burning sensation also felt in feet, calves, and knees, lasting at least 12 hours. Weakness in legs. Faint feeling. Increasing body aches over 12 hour period and still on-going 48 hours after injection. Within 12 hours, nausea, diarrhea, stomach cramps and on-going 48 hours after injection. 12 hours after injection, developed runny nose, sore throat, slight cough, watery eyes, headache. Runny nose, watery eyes on-going 48 hours after injection. Severe pain at injection site. Tenderness and redness continues 48 hours after injection. Within 6 hours of injection developed traveling itchiness starting at feet but moving to shoulders, scalp, hips, and hands.
This spontaneous report as received from a nurse via Company Representative refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route, lot # not provided). On an unknown date the patient developed tinnitus after receiving ZOSTAVAX. The outcome of tinnitus was unknown. Relatedness between the event and ZOSTAVAX was not specified. Additional information has been requested.
Side effects after Moderna's second dose; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Side effects after Moderna's second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Side effects after Moderna's second dose). At the time of the report, ADVERSE REACTION (Side effects after Moderna's second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.   Reporter did not allow further contact; 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.
Felt like the flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA (non-serious), outcome "unknown", described as "Felt like the flu".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Baby very irritable. Systemic macular/papular rash. Decreased appetite. Symptoms lasting over 2 weeks to date. Diarrhea intermittent.
Pt displayed what appeared to be a rash on both arms.  Pt said she already took Benadryl.
Patient had nausea and vomiting 10 minutes after receiving the vaccination. Approximately 5 minutes later, patient started to experience shortness of breath and tightness in her throat.
Unclear if related to vaccine, but just reporting: Chest cold>  Head cold> low fever, fatigue,  difficulty breathing>  vertigo. Symptoms have changed from one to another but going on 3 weeks now.