chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT VACCINATED WITH EXPIRED PRODUCT; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. 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. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced subject vaccinated with expired product. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of patient vaccinated with expired product was not reported. This report was non-serious.
First started out with being achey all over then about 1 hour later became so cold no fever as I check numbers times then became weak and nausea and then became sob check sats they were 70. Started using inhaler and neb tx for the next hour. Finally got the o2 sats up in lower 80's was going to go to the hospital but I figured they would do the same as I was doing. This lasted until after midnight until I got my o2 sats in low 90's. About 0100 the sob finally resolved. I started feeling normal about 0200.
1/28/2021 - began feeling tired at work.  At approximately 5:30 pm had a temperature of 101 and a headache.  Site of injection very tender, with redness and hot to touch.  Fever resolved overnight.  Had slight headache the next day and arm better.
This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 76-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient received the 2nd dose of SHINGRIX. On 30th June 2018, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced shingles and chest pain. On an unknown date, the patient experienced extensive swelling of vaccinated limb, injection site erythema, injection site warmth and incomplete course of vaccination. The patient was treated with VALTREX. In July 2018, the outcome of the shingles and chest pain were recovered/resolved. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema and injection site warmth were recovered/resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema, injection site warmth, shingles and chest pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for 2nd dose of SHINGRIX. The patient received the 1st dose of SHINGRIX vaccine on left arm. The next day she experienced a red spot at the injection site in size of 1 inch and which increased to 4 to 5 inches in size, along with swelling and heating at the injection site which spread down to the arm. This lasted for about a week and she recovered. On 30th June 2018, the patient experienced a mild case of shingles and pain around the chest above the left breast area. On 3rd July 2018, the patient visited her doctor. She was prescribed generic of VALTREX. The patient recovered in a week. Till the date of this report, the patient had not received the 2nd dose of SHINGRIX, which led to incomplete course of vaccination. The reporter had consented to follow up and had provided physician's contact details.
couldn't lift up her hand; Tendonitis; palpitations; shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of TENDONITIS (Tendonitis), PALPITATIONS (palpitations), DYSPNOEA (shortness of breath) and MOBILITY DECREASED (couldn't lift up her hand) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 011LZ014) for COVID-19 vaccination.     The patient's past medical history included Viral cardiomyopathy (Started year before the COVID pandemic and with exercise had palpitations when she is tired). Concurrent medical conditions included Drug allergy, Shellfish allergy and Iodine allergy.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced MOBILITY DECREASED (couldn't lift up her hand). In 2021, the patient experienced TENDONITIS (Tendonitis), PALPITATIONS (palpitations) and DYSPNOEA (shortness of breath). At the time of the report, TENDONITIS (Tendonitis), PALPITATIONS (palpitations), DYSPNOEA (shortness of breath) and MOBILITY DECREASED (couldn't lift up her hand) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: multiple contractions (normal) Normal sinus with multiple contractions..         Concomitant medication was not reported.  1st dose: 15Jan2021, Lot number; 011LZ014 (unsure if its an H or an A). About 3 weeks after the 2nd shot patient couldn't lift up the hand. Treatment medication was not reported.   This case was linked to MOD-2022-503135, MOD-2022-502854 (Patient Link).
This spontaneous report as received from a pharmacist refers to a 64 year old female patient. On 11-NOV-2013, the patient was vaccinated with PNEUMOVAX23 lot # J007786 (expiry date: 25-SEP-2014), intramuscularly. No concomitant medications were reported. On 12-NOV-2013, the patient experienced injection site reactions. The reporter also reported that 3 other patients also experienced injections site reactions following the vaccination with PNEUMOVAX23. The patient sought medical attention and contacted the pharmacist. The reporter described reaction as red swollen upper and lower arm at the injections site. Approximately on 17-NOV-2013 (reported as within 5 to 6 days), the patient recovered from the event. This is one of the four reports from the same source. Additional information has been requested.
pt recv vax & devel a inj site rxn characterized by redness, heat, soreness, & swelling from the should to the elbow.
Pt diagnosed with mild case of varicella on 4/5/04 in office. Broke out with rash/ bump late sat 4/3/04 afternoon, fever, itching. Treated with calamine lotion and benadryl by mouth as needed.
Developed phantosmia immediately following shot 1. I smelled cigarette smoke 24 hours a day. It got slightly better then the phantosmia got worse. I have been smelling smoke for 53 days now. I also developed 2 large nodes in my left clavicle area. Same side as shots. I had to have an ultrasound and 1 was suspicious so now have to have an MRI. I have been to an ENT and my PCP who feel this was caused by the vaccine.
fever after receiving her second dose; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date (43-year-old at vaccination) as a Dose 2, single for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a Dose 1, single for COVID-19 immunization. She stated that, she had been running a fever of 101.2 for a few hours and received the vaccine 26 hours ago. She also stated that she experienced a fever after her first dose, but it was "not that bad" and also reported "she had all the other symptoms that are listed in terms of headache, achiness, fatigue, and blah blah blah."  She was just concerned about the fever being this high and would like to know how long it was expected for this fever to last. She would like to know what medication she would recommend taking to help with the fever, as far as Ibuprofen or Tylenol. She would like to know if she should be concerned about running a fever after receiving her second dose of the Pfizer BioNTech COVID-19 vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Some fatigue for a few days after injection.  Swollen Lymph nodes in armpit of the arm receiving the injection.   Swelling has not subsided  yet.
Patient claims she was fine during the time of administration. States that it wasn't until later on at night where the injection site became red, swollen and itching. As time went on, the injection site became even more swollen and started moving down her arm. At this time the patient was concerned and went to the ER. Vaccine was administered around 4pm and patient went to the ER after 9 pm. Adverse reactions did not start till a few hours after the injection, per the patient.
none noted Narrative: Second dose of Moderna was given a few days early in error (first dose was 12/28/21 and second was given 1/19/21); therefore entering into database
Questionable reaction to DTP @ 3 months. No further reactions to vaccines as patient grew older. Remained in waiting room 20 minutes, started to leave complained of dizziness, weakness. No complaint of trouble breathing. Sat down remained another 20-30 minutes, no complaint and left. On way home complained throat itchy and broke out with hives. Went to personal physician and then on to ER per statement of mother and treated for vaccine reaction.
This spontaneous report as received from a pharmacist refers to a patient of unknown gender and age. On 25-JUL-2014, the patient was vaccinated with an expired dose of ZOSTAVAX lot#J000783, expiration date: 30-APR-2014 (dose, dose number, route of administration and indication not reported).  No adverse effects reported. Additional information has been requested.
One week later swollen lympe nodes for about two days.  lympe node goes down and the injection site was swollen and throbbing.  Applied ice and the swollen begin to subside but itching started.
Area of erythema with well defined border around DTaP injection site, hard, non tender. Area of redness is the size of a quarter, left thigh same. Area of redness a dime sized, TX with Augmentin.
Immunizations on 1/3/11 DTAP # 5 & VARIVAX # 2 (L) arm. Began 1/4/11 with redness & swelling of (L) arm from shoulder to elbow. Seen in office 1/5/11 am with MD.
Burning fatigue swelling clumsiness dizzy sore to touch 4 days later aching in every joint confusion
Vaccine on 3/28. 45 min after vaccine felt cold sweats, nausea. 3/29 ongoing cold sweats, nausea, fatigue, mild body aches. Went to work, symptoms worsened and developed severe body aches, headache, photophobia, gasping for air (but could breathe ok). Got up from a chair and syncopized, unknown amount of time unconscious. Taken to ED, normal exam, diagnosed with vasovagal syncope, went home to rest remainder of day. 3/30 still fatigued, tried drinking coffee and it spilled out right side of mouth. Looked in mirror and thought right eye and lip were drooping. Touched face and could not feel anything on right side. Also noticed splotchy red rash bilateral cheeks and left arm (same as injection) that was itchy. Saw PCP (via tele) who documented decreased right smile, forehead elevation, cheek puff and decreased sensation on face. Prescribed 7 day course of Valtrex TID and Prednisone 60mg daily which she began on 3/31. Seen by neurology (via tele) 4/1, patient indicating 50% improvement in symptoms but states she cannot feel entire right side of face or ear. When talking appears to only be talking out of left side of mouth but no flattening of right nasolabial fold, normal smile, cheek puff, questionable asymmetry of right forehead elevation but symmetric eyebrow furrow. Unable to assess forced eye closure. States she cannot feel pinch or nail on right side of face.
Blanchable erythematous macules on trunk, 3-5 mm indurated confluent, 1-2 cm of erythema with 2-3 raised papules on the (R) lateral thigh.
First Headache at approx 10:00pm then later that night at approx 02:00 am  left armpit pain, left  upper chest pain, left humerus pain, left elbow pain, left wrist pain,  left radius and ulna pain,  fatigue, lethargy, insomnia, fever 99.9 was highest taken with 2 extra strength Tylenol taken, chills, excessive sweating, decreased appetite until evening of the next day. arm pain decreased but arm pit remains swollen and painful for 2 days so far. Headache gone after 36 hours.
This spontaneous report was received from a nurse regarding multiple unspecified patients with unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unknown dates, unspecified multiple patients were vaccinated with improperly stored PROQUAD lot# M032497, expiry date: 02-JAN-2018 for prophylaxis (dosing details not reported). No adverse effects were reported. Temperature was 68F, time frame was 1 hour, no previous excursion and no data logger involvement. No product quality complaint was involved. This is one of the three linked reports. 1612USA009515 (Same Reporter Link) and 1612USA010738 (Same Reporter Link). Additional information has been requested.
About two months after receiving my third dose, I was diagnosed with esophageal cancer. I did not have chemo or radiation treatment, but I did have surgery on March 16th, 2022 to remove the cancer. As of my last checkup, I am showing that I am currently cancer free.
nauseous; extreme flu-like symptoms; couldn't eat; ruined her life; This case was reported by a pharmacist via call center representative and described the occurrence of nausea in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 2AH5M, expiry date 18th May 2021) for prophylaxis.   On 5th January 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a day after receiving Shingrix, the patient experienced nausea, influenza-like symptoms, unable to eat and decreased activity. On an unknown date, the outcome of the nausea, influenza-like symptoms, unable to eat and decreased activity were recovered/resolved.   The reporter considered the nausea, influenza-like symptoms, unable to eat and decreased activity to be possibly related to Shingrix.  Additional details were provided as follows: The patient experienced extreme flu like symptoms within 8 hours of receiving their 1st dose of Shingrix.  Symptoms were described as nauseous and could not eat, and that it ruined her life. Symptoms were lasted 10 days and have since resolved.  The reporter thought it was 95 parsent likely to have been caused by the Shingrix.  The reporter did not consent to follow up.
Light headache; Pressure on the back of the head; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), HEADACHE (Light headache) and HEAD DISCOMFORT (Pressure on the back of the head) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (Dizziness). On 29-Mar-2021, the patient experienced HEADACHE (Light headache) and HEAD DISCOMFORT (Pressure on the back of the head). On 27-Mar-2021, DIZZINESS (Dizziness) had resolved. At the time of the report, HEADACHE (Light headache) and HEAD DISCOMFORT (Pressure on the back of the head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
I had tremors for 2 hours constant shaking with no fever; joint and bone pain; joint and bone pain; headache; neck ache; diarrhea; no appetite; I felt crappy; my coordination is bad and mental capability is slow; my coordination is bad and mental capability is slow; vision was also blurred; have a stinging in my lung and i'm kind of short of breath; have a stinging in my lung and i'm kind of short of breath; started feeling ill; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 20Mar2021 09:00 (at the age of 66 years) (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation and experienced uncomfortable and feeling sick. Patient stated "after I got my 1st dose, I had side effects, but they were not as extreme as the 2nd dose. After the 1st dose I mainly had 2 days of being uncomfortable and feeling sick, it was over in 2 days. I took my 2nd dose on Saturday 20Mar2021 AT 9 am and started feeling ill at 2pm, I had tremors for 2 hours constant shaking with no fever, I had joint and bone pain, all my long bones in arms and legs aching, headache, neck ache, diarrhea and no appetite, I felt crappy. This morning I took a shower and found that my coordination was bad and mental capability was slow and vision was also blurred, but I was getting better when moving about, I was better than before." Patient had spoken to her doctor. Patient added "I was concerned with my lungs; I had a stinging in my lung, and I was kind of short of breath". The clinical outcome of the events was unknown at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This non-valid spontaneous report as received from a nurse refers to an unknown number of unspecified patients. The patients' concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not provided. On unknown dates, the patients were vaccinated with incorrectly stored GARDASIL 9 (strength and route of administration were not provided) lot # N000326, expiration date 14-OCT-2019 for prophylaxis. The vaccines were stored in temperature below 32 degrees Fahrenheit for 24 hours and 54 minutes. Digital data logger was involved. No adverse effects were reported. The outcome of the event was unknown.
Patient received Pneumovax and Flu in same arm. Once patient received Pneumovax, stated he was having trouble breathing and chest tightness, which then subsided. He then had lower back pain that was pulsating and radiating across his whole back. I called 911 and EMS was sent to the pharmacy. Patient was alert the whole time. Once EMS came, patients pain was lessening. Vitals taken. EMS and patient felt he was okay to go.
This case was reported by a other health professional via call center representative and described the occurrence of Guillain Barre syndrome in a patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, less than a year after receiving Flu vaccine, the patient experienced Guillain Barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the Guillain Barre syndrome was unknown. It was unknown if the reporter considered the Guillain Barre syndrome to be related to Flu vaccine. Additional details were provided as follows: This case was reported by a pharmacy intern. The patient had a Guillian Barre reaction to a flu vaccine in 2005. The brand name of flu vaccine and other details were not available at time of reporting.
I got the Covid vaccine on Tuesday morning. Mild headache and fatigue that afternoon, and also on Wednesday and Thursday. Very low-grade fever (99.3), On Friday afternoon, had severe stabbing pain in lower middle abdomen with severe cramping. Several bouts of explosive watery diarrhea. No blood in stool, and abdomen not sensitive to touch. But the level of pain was unusual. Pain lasted six hours. Somewhat relieved (so far) by Pepto-Bismol and Bentyl. Will not eat anything, or stay on a bland diet over the weekend to see if this improves.
Child came in for a well child check. Patient was supposed to receive Pentacel (DTap-Hib-IPV) instead patient received Tdap. Parent was contacted and informed of vaccine administration error. Parent was advised to monitor patient closely and if any symptoms occurred patient should be brought into clinic. Parent was also advised to bring patient in for an appointment two days after he was given wrong vaccine. Parent didn't bring child into the clinic as advised.
Sore throat, swollen gland right side of neck, cough. Absolutely no energy. Per family doctor - not an allergic reaction.
Mild/moderate anaphylactic reaction lasting about 45 minutes, trouble swallowing, fast pulse, disorientation, tight throat. Epinephrine not used.
rash started on abd about 2hr p/vax;fever noted about 10 hr p/;fever reported as 103;rash red & itching;rash & fever present until 17NOV97 when fever was w/in nl limits;rash cont;pt given DPH & motrin & APAP for fever;
Initial and follow up information has been received by follow up telephone call from a physician and a medical assistant (M.A.) concerning a 13 year old female with Epstein's anomaly and mild scoliosis who on 30-MAY-2008 was vaccinated with a dose of VAQTA (lot # 656996/0018U) and a dose of MENACTRA lot # U2225AA.  The MA reported that it was documented that patient received the vaccination and "the patient experienced a generalized seizure lasting for 5 seconds and awoke with normal mental status".  On 10-JUN-2008, the patient underwent a repair of Ebstein's anomaly of the tricuspid valve which included Bypass surgery.  The patient had a follow up visit with the physician on 24-JUN-2008 for the removal of sutures from the sternum.  She did not have any complications during or after the surgery.  She was scheduled to see a cardiologist "next week".  At the time of this report the outcome of the bypass surgery for Ebstein anomaly was unknown.  Upon internal review seizure and repair of Ebstein anomaly were considered to be an other important medical events.  This is one of several reports from the same source.  Additional information has been requested.
Injection given and onset s/s immediate, 72/58. Dizzy, pale, diaphoretic, clammy, thready pulse and decreased BP, emotional, 90/70, 92/64. Previous reaction to blood draw. Recommended medical f/u if s/s persist. 6:25 PM pt left w/mom. No further s/s.
Severe back, neck pain, severe headache, sore throat, swollen gland, fever, vomiting, and skin sores, malaise, fatigue, general Flu-feeling. Required 72 hrs quarters.
Patient's spouse alerted nurse that patient was "having trouble breathing". Patient reported feeling dizzy, clammy, and short of breath. Vitals were obtained and provider on call was alerted. Serial vitals taken from 3:05 PM to 3:43PM when Dr. discharged patient home. IM diphenhydramine 25mg administered per physician order at 3:25 PM. Patient reported no trouble breathing following medication administration and dizziness beginning to improve.  Initial Vitals (3:05PM):  BP 167/107 HR 105 O2 98% BP 153/93 HR 95 O2 99% BP 140/86 HR 75 O2 99% BP 140/94 HR 70 O2 98% Final Vitals (3:43 PM): BP 138/81 HR 76 O2 99%