chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial and follow up information has been received from a physician concerning his wife, a 67 year old white female, with no pertinent medical history and no history and no drug reactions/allergies reported, who on 02-FEB-2006 at approximately 9:30 am was vaccinated (route unknown) with another 0.5 ml dose of pneumococcal 23v polysaccharide vaccine  (Lot# unknown).  Concomitant therapy included paroxetine HCL (PAXIL), and levothyroxine sodium (SYNTHROID).  Within a few hours of vaccination, on 02-FEB-2006 (also reported as 20-FEB-2006), the patient developed a fever, some soreness at the injection site.  The symptoms continued through the night and she had no fever on 03-FEB-2006.  Follow up information from the physician also indicated that on 20-FEB-2006 the patient developed high temperature, sore arm prostration, malaise, and anorexia.  No urticaria or respiratory problems were reported.  She took acetaminophen (TYLENOL) for generalized pain.  The patient recovered several days later.  There was no illness at the time of vaccination.  No product quality compliant was involved.  The physician reported in follow up that the patient had her first dose about 10 years ago, a second dose in October 2005.  Her doctor insisted she get the shot, "didn't think of recent vaccination".  Additional information is not expected.
vials that underwent temperature excursion administered to patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (vials that underwent temperature excursion administered to patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (vials that underwent temperature excursion administered to patients). On 16-Mar-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (vials that underwent temperature excursion administered to patients) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter. No Treatment information was reported.
Patient hospitalized from  6/10-6/11 for chest pain that started on 6/9/21.  Diagnosed with perimyocarditis, elevated troponin peaking at 0.570.  EKG and transthoracic echocardiogram done.  Will be discharged on ibuprofen and colchicine.
pt recvd vax; sever soreness, pain , swelling, redness, warmth in arm; flu like sxs & myalgia; sxs resolved w/in 6 days
About 24 hrs post vaccine high fever TID3. Fever broke 3 days later (1/14/07). Developed maculopapular rash trunk and head a bit on extremities.
Patient woke up during the night with tenderness to his left arm and did not feel like he could move it. Had roommate help him move it around and took some ibuprofen. Presented today with some mild swelling and tenderness to left shoulder. No redness noted or fever reported. Able to move shoulder in all directions. Is feeling better. This is his 3rd shot in the series.
Pt.'s friend stating 06/11/2021 after receiving vaccination difficulty breathing, swelling of the face, dizziness/weakness, on/off fever, chills. Edema of both legs (Left more swollen), no seeping. No physician seen.
a dose of rotarix was given that expired on 05/02/2022; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Rota (Rotarix lyophilized formulation) (batch number unknown, expiry date 2nd May 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 12th May 2022, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 12th May 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator 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: 12-May-2022 Reporter's comment: Practice manager reported that on the date of reporting, a dose of Rotarix was given that was already expired on 2nd May 2022. The reporter unable to provide any additional adverse event information at this time. The reporter gave consent for safety to follow-up. Additional Supportive Information: The patient received an expired dose of Rotarix, which led to expired vaccine used.
Shortly after receiving vaccine, the patient was not acting like himself. Next morning, he vomited 4 times, had 2 loose stools, increased fatigue. Took to physician's office; was found to be obtunded. Transferred to ER where he had decreased mental status and was unable to protect his airway and was intubated, stabilized and transferred to PICU. Patient received 10day supply of Rocephin, 1 week of cithromax. Received FFP and cyro for discharge.
This spontaneous report was received from a physician concerning an 18 months old patient of gender unknown. The patient's pertinent medical history and concurrent conditions were not provided. On an unknown date at 15 months of age, the patient was vaccinated with the first dose of MMR II (route and lot number not provided). On an unspecified date at 18 months of age the patient was administered the second dose of MMR II (route and lot number not provided). No adverse effect was reported. Additional information has been requested.
Approximately 12 hours after receiving the shot I had intense muscle/bone/ body pain, leading to insomnia.  Headache, chills, fever. Fever ~100 to 101 Approximately 18 hours after the shot I had intense muscle/bone/ body pain, headache, chills alternating with intense sweating, nausea.  The intense body pain shifted around, but was largely concentrated in my sacrum area where I have a bulging disk.  Fever ~101 Approximately 24 hours after receiving the shot I experienced headaches, muscle/bone/body intense pain,  chills,  nausea  Approximately 30 hours after the shot I had all the above symptoms and I vomited.   Approximately  36 hours after I had above symptoms and I had  intense pain in my abdomen (liver, gallbladder, pancreas) and lower back- specifically right side, by my kidney area.   Approximately 48 hours after the shot my fever was back to 99-100 and I felt much better.  Still have headache, but intense muscle/ bone/body pain is much less.  Nausea is still there, but slight.
Initial misuse report received from a healthcare professional on 18 October 2013 and at GPV on 21 March 2014. A 03 year-old-10 months-old patient of unknown gender had received FLUZONE 0.25 ml. The patient received an incorrect dose. No adverse event was reported. The list of documents held by sender: None.
Around 910 AM he got 1st dose of TWINRIX and felt dizzy his BP dropped to 80/60 pulse 40, IV started.
one bruise on the left arm, one bruise on the left knee, bleeding in labia area.  Bruises were noticed 9 days after the shot. Bleeding happened 3 times during the first 12 days after the shot.  No treatments. Assuming I got immune thrombocytopenia (ITP).
Dizzy; by the time I got up on tue. I had the shakes,; Nausea; when I tried to eat I threw up,; can feel my lymph nodes are slightly swollen,; as well as Joint pain,; Chills; Muscle pain; One day after the shot my arm felt like I had just received a tetnis shot. I got the shot 17 apr a sat. by monday I was feeling weak; Slept for 24 hours; Have eat on once since Sunday; Weight has dropped from 185 to 172.; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: 59267-1000-01) via an unspecified route of administration in the left arm on 17Apr2021 at 09:15 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history included recovery from heroin addiction from past 26 months and allergy to penicillin and its relatives. Prior to the vaccination, the patient was not  diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included clindamycin (MANUFACTURER UNKNOWN) for unknown indication on unknown date and unknown if ongoing. On 19Apr2021, one day after the shot, the patient arm felt like receiving a tetanus shot and weak, so he layed down and slept for 24 hours. On 20Apr2021, the next day, by the time the patient got up experienced shakes, was dizzy, had nausea, when he tried to eat he threw up, lymph nodes were slightly swollen, as well as joint pain, chills, and muscle pain. On 21Apr2021, on the next day, it was worse. On 22Apr2021, after a day, the patient felt slightly better. The patient reported that he was in contact with doctor and was told to rest, take tylenol and if symptoms get worsened then to go to the emergency room. The patient was resting, but have eaten only once since 18Apr2021, the day after vaccine. The patient weight had dropped from 185 to 172 (unspecified units). The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events arm felt like had just received a tetanus shot and felt weak, layed down and slept for 24 hours, shakes, was dizzy, had nausea, threw up, lymph nodes slightly swollen, joint pain, chills, muscle pain and weight dropped from 185 to 172 (unspecified units) was resolved with sequelae on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Since receiving the vaccine I have had continuous episodes of insomnia and headaches. The headaches are not resolved with OTC products.
This spontaneous report was received from a nurse practitioner refers to a 60 years old female patient with hypertension and allergy to penicillin who on 30-AUG-2012, was vaccinated subcutaneously with a single dose of ZOSTAVAX (lot number H010656, Exp. Date: 01-SEP-2013) (dose not reported). No other co-suspects were reported. Concomitant medications included DIOVAN, BONIVA and calcium. The nurse practitioner reported that the patient on 31-AUG-2012, developed a rash. The patient came to the office for evaluation and was found to have a flat, red, itch rash on her neck, both arms, chest, abdomen and back. The patient was given DEPO-MEDROL injection and CLARITIN in the office. The patient was prescribed a MEDROL dose pack, CLARITIN and BENADRYL to be taken at home. No lab diagnostics studies were performed. At the time of the report, the patient had not recovered. The relatedness for patient was found to have a flat, red and itchy rash on her neck, both arms, chest, abdomen and back was unknown for ZOSTAVAX. Additional information has been requested.
34 week twin gestation at time of vaccination. Healthy pregnancy. No comorbidity.  Developed headache and sore throat on Jan 19 . Headache continued and developed Pre-Eclampia (diagnosed Jan 24th-25th). Emergent C-section for Pre-Eclampsia on Jan 26th. Infants spent 3 days in NICU for tachypnea/bradycardia/apnea spells and mother (the vaccinated patient) went to ICU at 12 hours postpartum for syncope episode. The twin infants birth weights were 5 lb 8 oz and 5 lb 13 oz and were discharged on DOL 3 to 5. Mother discharged home at day 3 to 4 post birth.
Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Chills-Medium, Systemic: Hot to touch/ Cellulitis-Severe, Additional Details: MD diagnosed the patient with Cellulitis. She described that her injection site is hot and was rash-like and about a credit card site for the first day. Day 3 she still has the rash it is just traveling down her arm to her elbow now it is hot to the touch and the doctor diagnosed her with cellulitis. She did complain that it has progressively get worse over the couple of days.
Pt. experienced a fall at home and presented to hospital on 04/17/2021; diagnosed with fracture; discharged to Extended Care Facility on 04/24/2021.
LUE erythema and pain measuring 20 cm x 23 cm, warm and tender to touch. Fever/chills the first day, then fever in the evenings for a few days after. Nausea and headache. Decreased appetite.
pt presented w/ax temp of 103;mom treated temp w/APAP 12JAN96;pt ax temp went to 105.5;mom took pt to ER where dx w/severe sore throat w/ulcerations;tx Motrin & Keflex
pt recv vax 13OCT97 & OCT pt exp swelling of arm that affected the movement of hand;
Mild rash, about 3.5 inches diameter, started on left deltoid around injection site, pink and raised 1cm splotches.  Arose after hot shower.  In about 1 hour, became one big rash, darker pink.  Itched some/burned slightly.  Felt in quality similar to lamictal rashes patient previously experienced.  Rash lasted about 3 days and slowly expanded by about 2 inches in diameter, fading and itching less, until gone.  Applied hydrocortisone cream after about 1 day to relieve itching.  Rash otherwise resolved with no first aid/other attention.
severe swelling in the thigh and knee after the injection; a 18 months old male patient received a 0.25 ml dose of  Fluzone Quadrivalent vaccine; Initial information received on 25-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer (office staff).  This case involves a six years old male patient who experienced severe swelling in the thigh and knee after the injection (oedema peripheral), while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 28-Sep-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via intramuscular route in the right thigh.  On an unknown date, the patient developed a non-serious severe swelling in the thigh and knee after the injection (oedema peripheral) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was a case of vaccine underdose. When he was 18 months old the patient received a 0.25 ml dose of  Fluzone Quadrivalent vaccine.  (Other relevant tests included no lab data.)  Final diagnosis was oedema peripheral.   It was not reported if the patient received a corrective treatment.  The patient was not recovered from the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sore Arm; Uncomfortable; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd March 2019, the patient received Shingrix (intramuscular) .5 ml. On an unknown date, 122 days after receiving Shingrix, the patient experienced pain in arm and arm discomfort. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the arm discomfort was unknown.   It was unknown if the reporter considered the pain in arm and arm discomfort to be related to Shingrix.  Additional case details were reported as follows: The vaccine lot number and expiry date was not readily available The patient received vaccine in left deltoid. The patient initially felt fine following vaccination but was now complaining her arm was sore described as being uncomfortable when trying to undo bra strap. The reporter unsure if sore arm was related to injury or vaccine. The reporter gave permission to follow up. This case had been linked to the case US2019133834, reported by same reporter. In the document outcome of events was reported as recovering, but in the database its mentioned as not recovered, so kept as reported in database.
On 02/07/2022 Patient was administered 0.25 ml Moderna booster that was in fridge for 33 days which is over 30 days recommended. I emailed Moderna about it and was notified  that The vaccine administered on February 7, 2022 from lot number 033H21A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. No repeat dose is needed.
This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous for prophylaxis (lot #, expiration date, dose and site of administration was not reported). On an unknown date, the patient experienced dermatological reaction to the vaccination. The pharmacist advised the patient to consult a doctor for treatment. The patient received an unspecified treatment. The outcome of dermatological reaction was unknown. The reporter considered dermatological reaction to be related to ZOSTAVAX.
Diarrhea & NauseaVomiting Narrative:   Other Relevant History:
Patient had injection site reaction (injection site became red, enlarged, and warm). She took ZYRTEC, BENADRYL and never decreased by 9-3-14, so she went to doctor. Swelling hasn't gotten any larger, but it hasn't gone down. Dr told her it is an injeciton site reaction and continue BENADRYL.
pt co-worker called on 1JUL97 3PM to report to WIC immun nurse that pt c/o soreness to arms & stiffness in jaw area w/diff of chewing which started on 30JUN97;soreness in arms began next day p/vax;
I went into afib around 11pm it lasted all night ending about 8:30am. I dont have episodes its been well controlled with meditation and avoiding certain foods and drinks and dehydration. I hadnt consumed anything out of the ordinary and had taken the meds the usual times. If i get a bit dehydrated it often sets off an episode. Maybe that happens with the vaccine for a little while after. I didnt go to a doctor.
Vaccine given 5/10/04 to 4 year old with hemophilia A. Ice packed. Developed erythema, tenderness and fever to 102 degrees.
WEAKNESS, FATIGUE. SHAKY, DIZZY. HYPERTENSIVE 190/80. REQUESTED TO GO TO THE ER. DISCHARGED HOME AFTER EVAL IN THE ER
Large (~2 ? diameter) hard, raised, swollen, hot knot of painful red flesh at the injection site, started 02/01/19 and still present 02/03/19. Mild fever (100 degrees), aching hip and buttock muscles and extreme fatigue, onset 02/02/19, diminishing on 02/03/19. NOTE: First dose of SHINGRIX vaccine, given 09/18/2018 resulted only in a mildly painful area on the upper arm.
This spontaneous report as received from a registered nurse refers to a 4 year old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided.  On 06-SEP-2016, the patient was vaccinated with improperly stored M-M-R II lot # M004305 (dose, frequency, expiry date were not reported) for prophylaxis. The vaccine was purchased with private funds/insurance. The temporary temperature excursion occurred in the fridge on 01-SEP-2016 however, it was not discovered until 26-SEP-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA013814: US-009507513-1609USA014830: US-009507513-1610USA004339.
2hrs post Vaccine Pt returned to Clinic and stated she felt like she had a rapid Heart rate. Upon examination pts heart rate was found WNL and Bp slightly elevated. Pt had no other signs or symptoms vital signs were all wnl upon a 12lead did find a N/S rythm with a 1st Degree AV Block No st elevation or depresion noted. BS reading of 184, PT states she is a diabetic and did not take her Metformin this morning, no other changes in pt condition. no other findings notedPt was transported for evaluation at local hospital via paramedic ambulance.
seizure reaction within 5 minutes of receiving vaccine. dry heaving, unresponsive, seizure, numbness in both arms, confusion, headache for 24+ hours.
? 2nd dose of Pfizer on Friday 2:30 pm.  ? Started to have Diarrhea and vomiting, nausea and chill Saturday 6:00 pm. Cannot eat as I vomited after eat.  ? Side effects gone Monday midday.  ? Resume daily activities on Tuesday .
Patient received the booster dose of the Moderna covid vaccine on 11/03/2021 and then on 11/04/2021 he started to notice a sunburn sensation on his left shoulder. On 11/05/2021 developed a painful rash on the left shoulder and trunk. I saw him in office 11/09/2021 and diagnosed him with Shingles.
36hr p/vax macular rash on chest, back & neck;isolated on face;p/5 days rash almost gone;Neosporin ointment;
24hr p/vax pt devel soreness & pain lateral & inferior to inj sites & flu like sx w/nausea & stomach pain;inc redness & hot, red area (not directly) @ inj site;seen by MD;T99.2;rx w/rocephin;cellulitis;
Patient fainted 5-10 minutes after getting the shot, called 911- gave him EPIPEN. I called the ER 4 hours later, Dr. said he was OK left home. Then I spoke with the patient at 6:45 pm at home, he was feeling very good.
New oral herpes simplex lesion (on lip); Headache; fatigue; right arm pain; painful lymph nodes on right side of neck; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient (Non-pregnant) received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EP6955, expiry date was not reported), via an unspecified route of administration, administered in arm right on 30Mar2021 13:15 single dose for covid-19 immunisation. Patient's medical history was not reported. Concomitant medication(s) included levothyroxine, famotidine, Colecalciferol taken for an unspecified indication, (within 2 weeks of vaccination) start and stop date were not reported. Patient had no allergies to medications, food, or other products. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination. Patient previously took vaccine included BNT162B2 on 10Mar2021 13:15 single dose for covid-19 immunisation. The patient experienced right arm pain on 30Mar2021, painful lymph nodes on right side of neck, On 31Mar2021 headache, fatigue, new oral herpes simplex lesion (on lip) on 06Apr2021 10:00. The patient received treatment for the event new oral herpex simplex lesion that included One dose Valacyclovir 2g. No Covid Prior Vaccination. No Covid tested Post vaccination. The outcome of all the events are recovering except the event "new oral herpes simplex lesion (on lip)" was not recovered.    No Follow-up Attempts are needed.
RASH ON FACE, NECK, CHEST AND ARMS.  MILD NAUSEAS AND ELEVATED BLOOD PRESSURE. TREATED WITH BENADRYL 50MG IV. RASH LASTED 15 MINUTES AFTER IV TREATEMENT.