chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu vaccine was given in left upper arm. Area was sore for the first few days then began to hurt in certain positions and especially at nighttime, progressively worsening. By the third week after vaccine unable to move arm in certain positions due to pain at night. Unable to sleep due to pain. Difficulty breastfeeding baby due to pain in certain positions at nighttime. Daytime symptoms not as severe but constant aggravation and inability to move arm in certain positions.
No adverse effects reported; improperly stored doses of  PROQUAD was administered to the patient; This spontaneous report has been received from an office manager (medical assistant) regarding to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medication, drug allergies or reaction were not reported.     On 11-APR-2019, the patient was vaccinated with an improperly store dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (recombinant human albumin, rHA) (lot # R008206 and expiration date 16-SEP-2019) (dose and anatomical location of vaccination was not reported) mixed with a properly stored sterile diluent (DILUENT MRK) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion to 9°C to 25 °C (20.5 °C) for a time frame of 22 hours and 30 minutes. From -9°C to 8°C for 1 hour 15 minutes and -14 °C to -10°C for 1 hour 30 minutes. There was no previous temperature excursion. The call was because of a "data logger". There were no adverse effects reported.   This is one of several report from the same reporter.; Sender's Comments:  US-009507513-1905USA010083: US-009507513-1905USA010084: US-009507513-1905USA006081: US-009507513-1905USA010085: US-009507513-1905USA010080: US-009507513-1905USA010081: US-009507513-1905USA010092:
Information has been received from a medical assistant (RMA) concerning an unknown number of unspecified patients (unknown ages and genders). Pertinent medical history of the patients and their respective concurred conditions were not provided. It was reported that on 20-MAR-2016 or after, an unknown number of unspecified patients were vaccinated with improperly stored doses of ROTATEQ lots # K020181 and L008054 with expiration dates 24-JUN-2016 and 30-NOV-2016 respectively (dosages and dose numbers were not reported), administered per oral route. Concomitant therapies were not reported. The RMA stated that on 20-MAR-2016 the patients were administered improperly stored doses of ROTATEQ lot # K020181 expiry date 24-JUN-2016 were administered; any improperly stored doses from this lot were administered on unknown dates prior to expiry. No adverse effects were reported at the time of the report. The excursion details were: Temperature: 9.8C- Time frame: 12 hours- There was no previous temperature excursion- It was call due to a data logger. No product quality complaint (PQC) was involved. Additional information has been requested. This is one of two reports from the same source (MARRS # WAES1608USA005915).
My daughter was diagnosed with Primary ovarian insufficiency in 2017 after visiting the doctor for amenorrhea and undergoing numerous test and diagnostic imaging to come to the diagnosis. Patient completed the HPV series (9/9/13, 8/9/14, 8/19/15) in2015, she developed undetermined intermittent abdominal pain months after the first dose of GARDASIL but not until after being diagnosed wth POI did I correlate the abdominal pains with the GARDASIL series.
3 hr after injections, patient had fever >103 degrees F with chills, vomiting, body aches and lethargy.
Pt received primary series of Moderna and today received a bivalent booster of Pfizer. There are no adverse reactions at this time.
Pt given vaccine on 7/10/18. Came in 7/13/18(approx. 3pm) to report tingling sensation in arm, radiating pain from injection site up side of neck, and migraine. I advised Pt to take TYLENOL or IBU. She could also seek medical attn. Pt seemed unsatisfied with these answers.
Approximately 3 months after receiving second moderna vaccine both my arms from my elbows to my finger tips were swollen to the point of not being able to make a closed fist,  they were both tender to the touch.  The pain/ swelling was not of joint pain but of tissue.  I could not work as a result,  and went to seek medical treatment.
Pt developed cellulitis of right upper arm 5/8/2012. Pt was treated 5/9/2012 with Cephalexin 250mg/5ml suspension, 2tsp 3x/day for 10days. Pt also advised to use cold packs and Ibuprofen for pain.
SQ Varicella given on back of L arm, on 1-19-11 pt presented back to clinic 1-24-11. Spot of irregular, red raised rash where shot was given. Pt was referred to her PCP for further evaluation.
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 30-SEP-2020, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB), 1 injection, lot # S022584, expiration date: 31-OCT-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursion of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: S022584; expirationdate: 31-OCT-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; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Nausea & vomiting, pain in legs "like a rubber band cutting off circulation".  Patient went to doctor on Saturday night.
Approximately 1 week after receiving seasonal flu shot developed "pins and needles" feeling all over body subsequently developed. 11/4/09 DC summary and medical records received for dates 10/10/09 to 10/19/09.  DX: facial diplegia. C/o facial numbness, unable to smile, close eyes,  tingling over body, chest tightness,  IVIG tx x5 days with improvement. 12/23/09 Additional Hospital records received for DOS 10/10/09-10/19/09  Neurology consult obtained for bilateral facial weakness. Treated with prednisone and IVIg DC DX: probable polyneuritis, Hypertension ; hyperlipidemia
This spontaneous report was received from a physician refers to a 13-year-old female patient, with no drug reactions or allergies and no pertinent medical history. Current condition included contact dermatitis of the nose. The patient was vaccinated with dose 1, 0.5 milliliter (ml) GARDASIL (lot # 0636AE, expiration date unspecified) intramuscularly on 15-AUG-2012. Concomitant medications included: Z-PAK (reported as Z-Pack). The patient had been seen for contact dermatitis of her nose on 15-AUG-2012 and was prescribed Z-PAK and was administered GARDASIL, on the same visit. On the same date on 15-AUG-2012 the patient developed fever 102 degrees. The fever resolved on 16-AUG-2012. The physician did not administer the scheduled second dose of GARDASIL on 27-SEP-2012 because of the fever with the first dose. Treatment information was unspecified by the reporter. Medical attention was not sought for the events. No further information was provided. Additional information has been requested.
Syncope, hypothermia, shock, hypotension, arrhythmia, diarrhea, vomiting
Patient experienced some mild pain to the left arm several hours after receiving. On 8/22/12, the day after injection, she noticed her arm was sore, swollen and hot to touch. The redness continued to enlarge to 2.25" when she came in on 8/23/12 to have it checked. No known insect bites.
p/vax pt was  whiney, gassing;had diarrhea & was inconsolable for 3-5 days;
pain in the leg muscle (back of the leg) Pain was described as electric shock; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (pain in the leg muscle (back of the leg) Pain was described as electric shock) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 041L204) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol, Prostate cancer and Indigestion. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (pain in the leg muscle (back of the leg) Pain was described as electric shock). At the time of the report, MYALGIA (pain in the leg muscle (back of the leg) Pain was described as electric shock) outcome was unknown.     Concomitant product use included cholesterol medicine, prostate cancer medicine and indigestion medicine. The patient did not take anything to treat symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Additional information received captured reporter contact details.
I developed a rash on my left side on 4/5/2021 that became more painful over the next 3 days. I saw a doctor on 4/8/2021 who diagnosed the rash as shingles (Herpes zoster without complication). I was prescribed valACYclovir 1000 MG tablet to take 3 times a day for 7 days.
Arm pain, felt "spacy-mental fog" for about 6 hours Narrative:
Swelling, pain, and induration at injection site on left leg (Prevnar).  Red area around 4 inches across, also around injection site on left leg. Irritability and increased sleepiness.  Stumbling either from pain, dizziness or lack of coordination (exact cause unknown).
PT states getting the COVID vaccine moderna x2 days ago with dizziness, nausea, and light headedness starting yesterday night. 19-year-old female comes to emergency room for 48 hours of nausea, vomiting and headache.  Her examination was not concerning for bowel obstruction or serious underlying bacterial infection.  She is subjectively improved after 2 L of normal saline hydration and Zofran 4 mg.
It was mostly pain - it would come and go randomly. Feel it when I take deep breaths in mostly. I had had COVID in August in 2020 and I thought maybe it was lingering effects. Chest pain - Right around my left upper rib and it would shoot through my left chest and up into scapula area - when I was doing exercise bike. Bending forward, I would also feel that pain. I scheduled a doctor's visit - about April 29th. This was daily pain for about two months that it had been happening. I went to the doctor when it was starting to get better. It kind of resolved on its own. No treatment It's 90% today. But it still occurs at times and very randomly. I felt it today. It stopped me for a second and then it was gone.
nausea, elevated temp, excessive urination, swollen soft tissue (mouth, tongue), painful urination - bladder and kidneys, extreme weakness, no interest in food.
Immunizations were given. Mom got baby dressed left the room and noticed infant's face was red/blotchy (approx within 3 min or less). Face remained red/blotchy and had a few red raised bumps on forehead. There were a few red raised pinpoint bumps around vaccination site (where INFANRIX was given). Infant was stable, no respiratory issues. Mom took infant to pediatrician. They told her it was an allergic reaction. No meds or interventions given. They gave her advice of symptoms that would require emergency attention. After immunization was given infant's mother stated mother was allergic to DTAP immunization and mother has had hives in the past after receiving it.
SEVERE HEADACHE WITH CHILLS, SEVERE ENDO CRAMPING, JOINT PAIN WITH VERY LIMITED RANGE OF MOTION (ANKLES, KNEES AND ELBOWS) FEVER AND SWELLING IN INJECTION SITE, PAIN STILL PRESENT IN JOINTS, ABDOMINAL AREA AND INJECTION SITE (20150115/1622) AT TIME OF SUMBISSION OF THIS REPORT.
Initial report received on 20 March 2007, from a consumer, who is the patient.  56 year old female received on 25 April 2006 a dose of DECAVAC (lot# U1707BA), left deltoid.  It may have been subcutaneous to the back of the arm.  The patient had received many previous doses of DECAVAC.  She had received DECAVAC in intervals of 6 years, for travel.  Within three days her left deltoid became hot, swollen and sore.  Within 8 days of vaccination, swelling was under the left arm down to the elbow.  She saw a physician who said it was adverse event reaction.  Treated with antibiotics.  On 20 March 2007, 329 days post vaccination, she had 5 x 5.5 inches brown spot at injection site and still got itchy.  She was told by a physician to never get TD shot.  She required emergency room/doctor visit on 02 May 2006.  The patient had not recovered.  The patient medical history included: Mitral valve prolapse and allergy to sulfa drugs.  No illness at vaccination time.  No other vaccines were given prior to vaccination with DECAVAC.
Pt has had multiple red bumbs or hives on numerous parts of body beginning the day off vaccination. The red areas itch and are painful to the pt.  Areas include her arms, face, legs, hips, head, face, feet (various spots from head to toe).  Some of the red areas come and go. some of the red areas (such as on arms) have been persistent.   Treatment: dephenhydramine, zyrtec, medrol tablets
Fever and body aches. It feels like when I had covid a month and a half ago.
Very red, swollen, little larger than quarter sized, and tender 05182007, give tyl for pain and apply ice, mom called back on 05252007 to report Chicken pox rash, advised to give her benadryl
Few minutes after vaccination during observation peroid, patient began feeling lighheaded and that she might faint.  Patient did not lose conciousness and was laid supine on the floor, within 30 seconds patient stated all symptoms resolved. She remained in the area for another 15 minutes without subsequent symptoms. She left with a friend and was instructed to see her PCP for follow-up if needed.
shingles; Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information about medical history, concurrent conditions and concomitant medication use was provided. In 2016, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dose, and route were unknown) as prescribed and/or administered by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to the patient's zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a physician for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX), the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was reported as not recovered/not resolved. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
I experienced a reaction known as Covid Arm. It started with a small itchy red spot on my arm slightly below the injection site. It progressed to a very large, red, inflamed, hot to the touch, itchy rash that took about 5 days to go away completely.
Left arm swelling and redness at injection site; left armpit lymphadenopathy- approximately size of golf ball with soreness/tenderness. Pain/numbness down from left arm to left hand. Left side of neck sore/tender/swollen lymph nodes and itchiness. Mouth and throat itchy and excess saliva production/phlegm.
15 minutes after dose, complained of itching. Sent to Emergency Department. Found to have lacy erythematous rash on thighs and back. No breathing difficulty and no swelling. Received diphenhydramine IV, famotidine IV, and methylprednisolone IV. Discharged with prescriptions for oral diphenhydramine, famotidine, and prednisone. Returned to ED 15 hours after dose complaining of fatigue and extremity weakness. No rash, no breathing difficulty, and no swelling noted. Admitted for observation and to rule out neurologic syndrome. Workup negative. However patient reported transient neurologic symptoms at various times in the past. Discharged with instructions to follow up with neurologist in the future.
some hearing loss; Severe Tinnitus after the second which has not gone away; This is a spontaneous report from a contactable consumer, patient. A 63-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0151) via an unspecified route of administration, in the left arm on 03Mar2021 as a single dose for COVID-19 immunisation. The patient medical history was not reported. Since the vaccination, the patient has not been tested for COVID-19. Concomitant drugs were not provided. The patient previously received the first dose of BNT162b2 in the left arm on 03Mar2021 at 15:00 (Lot Number: EN6199) for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 10Apr2021 at 03:15, the patient experienced some hearing loss and severe tinnitus after the second which has not gone away. The patient reported, she noticed ringing in the ears (tinnitus) after the first one then went away. Severe tinnitus after the second which has not gone away. Doc sent me for hearing test. Which I've had some hearing loss. No treatment was provided for the events.  The patient had not recovered from the events, some hearing loss and severe tinnitus after the second which has not gone away.
Local cutaneous reaction to second Varivax (VZV) (erythema and induration with tenderness, 6 cm by 7 cm area)
2 hours after receiving vaccination she developed swelling and pain in right shoulder which the ER evaluation determined to be due to a large hematoma over the right deltoid.
Received vaccine 3/6/21, had Right Hip replacement surgery on 3/23/21 and had arterial blood clot post surgery with revascularization. Surgery performed by Dr. at a Medical Center
was sick with flu symptoms for 3 weeks; Initial information received on 21-Nov-2020 regarding an unsolicited valid non-serious case from a patient via company through social media .  This case involves a patient with unknown demographics who was sick with flu symptoms for 3 weeks (influenza), while being treated with vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was not reported.  On an unspecified date in 1998, the patient received a dose of suspect INFLUENZA VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose and frequency via unknown route and unknown site for prophylactic vaccination.  On an unknown date (unknown latency), after starting the suspect vaccine therapy, the patient was sick with flu symptoms for 3 weeks (influenza) after having never had the flu before and never had the shot or the flu since then.  No laboratory data was not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.
Myalgia, CoughWheeze,  fatigue  Narrative:  Employee reported fatigue, muscle aches and cough that started 24 hours after the shot, and lasted 1.5 days
Face is swollen up and its all red and blotchy; Face is swollen up and it's all red and blotchy; Face is swollen up and it's all red and blotchy; This is a spontaneous report from a contactable consumer (patient's parent). A female patient (reporter's daughter) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 13Jun2021 as unknown, single dose for COVID-19 immunization. Medical history and concomitant medications of the patient were not reported. Reportedly, patient had no allergies to any other medicines. On 13Jun2021, after vaccination patient experienced her face was swollen up and its all red and blotchy. Reporter stated "My daughter had the COVID Vaccine today, and her face is swollen up and its all red and blotchy. Reporter don't know what to do. If it is an allergic reaction or what, Reporter don't know because she has not had any allergies to any other medicines, that's they put on the thing." Outcome of the events were unknown.  Information on Lot/Batch number has been requested.
Patient reports pain in the chest 15 mins after vaccination. Exanimated patient with airway, administered site (arm), did not see signs of symptoms of allergic reactions. No Epipen, nor diphenhydramine was given at the time. Patient requested to call for ambulance and be taken to the emergency room.
I woke up this morning and was disoriented, had a headache, went to get glass of water and fell down, fainting, was unconscious for 1 minute.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported.  On 06-SEP-2014, the patient was vaccinated with PNEUMOVAX23 lot # J006242, expiration date 30-AUG-2014 (also reported as 03-AUG-2014, 0.5 ml, intramuscular). Secondary and concomitant therapies were not reported. Pharmacist reported that a patient received a dose of PNEUMOVAX23 that had expired. No adverse effect reported. Additional information has been requested.
Lethargy; Sniffles; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargy) and RHINORRHOEA (Sniffles) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-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 LETHARGY (Lethargy) and RHINORRHOEA (Sniffles). At the time of the report, LETHARGY (Lethargy) and RHINORRHOEA (Sniffles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.