chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; Information has been received from a lawyer and an elderly female patient (pt) of unknown age regarding a case in litigation. Information about the pt's concurrent condition, medical history and concomitant medication was not reported.   In 2013, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for prophylaxis.   On an unknown date, as a result of zoster of her receipt of vaccine live (ZOSTAVAX), the pt was caused to suffer shingles, including any an all of its sequelae. The pt had suffer severe personal injuries, pain, suffering, and emotional distress as well as to incur substantial economic damages. The pt was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. The pt required and/or would require more health care and services and incurred medical, health, incidental and related expenses. The pt was informed and believed and further alleged that she would in the future be required to obtain further medical and/or hospital care, attention and services.
Abrupt hive like rash starting on 11/6.  Discrete separated hives clustered around L lateral chest wall/axillary region and more diffuse on back and abdomen. confluent at posterior neck and diaper line. no facial, palmar, oral or perineal involvement  progressed and spread  on 11/7, involving face, majority of trunk. became more purple in color with central clearing and surrounding erythema. developed fever 100.5. seen in ED and by dermatology econsult. differential diagnosis was serum sickness versus acute urticaria versus urticaria multiforme. treated with antihistamines and topical steroids
This spontaneous report was received from a office manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 31-JUL-2017, the patient received an improperly stored dose in immunization series of PNEUMOVAX23 injection (lot # N010106 with expiration date at 15-NOV-2018; strength, exact dose, route of administration and anatomical location were not reported), for prophylaxis. The administered dose of vaccine was exposed to a temperature of 32 degrees Fahrenheit (F) for 168 hours. There was no previous temperature excursion. Data logger was not used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several report received form the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1708USA004073: US-009507513-1708USA003345: US-009507513-1708USA004070: US-009507513-1708USA004072:
Multiple lesions (>40) in various stages; erythema with central vesicle. Afebrile.
Lower abdomen cramping that feels like menstrual cramps. Started after 2nd dose of Moderna. Cramping occurs 3-4x per week with bending over, sometimes at rest.
Severe lower back pain with red patch (size about 1 inch diameter); Severe lower back pain with red patch (size about 1 inch diameter); Extreme pain while changing posture, sitting, standing; Lot of stiffness in lower back; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 04Apr2021 at 17:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. 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 COVID-19 vaccine. Concomitant medications included vitamin d nos (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. On 07Apr2021 at 06:00, the patient experienced severe lower back pain with red patch (size about 1 inch diameter), had extreme pain while changing posture, sitting, standing, etc. and lot of stiffness in lower back. The events resulted in emergency room/department visit or urgent care. Therapeutic measures were taken as a result of events and included treatment with menthol/methyl salicylate (BENGAY) for 2 days. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe lower back pain with red patch (size about 1 inch diameter), extreme pain while changing posture, sitting, standing and lot of stiffness in lower back were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
No events occurred. We were advised by our local health officials to file the vaccination in VAERS due to the patient being slightly under the age of 18.
redness close to the injection site; swelling close to the injection site; pain close to injection site; bumps in the arm; itchiness close to the injection site; bump close to the vaccination place; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness close to the injection site), VACCINATION SITE SWELLING (swelling close to the injection site), VACCINATION SITE PAIN (pain close to injection site), NODULE (bumps in the arm) and VACCINATION SITE PRURITUS (itchiness close to the injection site) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medically reported history).    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness close to the injection site), VACCINATION SITE SWELLING (swelling close to the injection site), VACCINATION SITE PAIN (pain close to injection site), NODULE (bumps in the arm), VACCINATION SITE PRURITUS (itchiness close to the injection site) and VACCINATION SITE MASS (bump close to the vaccination place). At the time of the report, VACCINATION SITE ERYTHEMA (redness close to the injection site), VACCINATION SITE SWELLING (swelling close to the injection site), VACCINATION SITE PAIN (pain close to injection site), VACCINATION SITE PRURITUS (itchiness close to the injection site) and VACCINATION SITE MASS (bump close to the vaccination place) outcome was unknown and NODULE (bumps in the arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reports taking HYDROCHLORIDE STEROID (NOS) and an ANTIHISTAMINE pill (NOS) to treat symptoms.   Concomitant medications were not reported.
INTENSE ITCHING/ HAIR ITCHING; This spontaneous report received from a patient concerned a 57 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history was not reported. Concurrent conditions included: walnut allergy (results in itch/rash). On an unspecified date, the patient previously received covid-19 vaccine ad26.cov2.s vaccination (dose series 1)(unspecified manufacturer) for prophylactic vaccination and it was unknown whether patient had any adverse events (dose series 1). The patient received covid-19 vaccine ad26.cov2.s (dose series 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported,1 total administered on 09-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-NOV-2021, the patient experienced intense itching/ hair itching by 4 hours after receiving her booster (dose series 2). She reported taking diphenhydramine hydrochloride 2-3 hours after her booster but by 4 hours she was itching so bad. On 11-NOV-2021, the patient went to see a nurse practitioner and started fexofenadine hydrochloride for intense itching/ hair itching.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from intense itching/ hair itching. This report was non-serious.
Besides sore muscle at injection site [which is always the case] I have had a sore throat, nasal stuffiness, runny nose, sneezing, mild headache, and gastrointestinal distress.
Pt called the clinic noting his vaccine injection site was hot, red and tender on Nov 11. The symptoms continued even after trialing at home therapies such as Tylenol and ice. The pt presented in the clinic on Nov 13th and was seen and treated for cellulitis.
At 3:30 pm pt developed swelling slight left arm redness advised to apply ice and take BENADRYL. At 8:30 pm pt became very shaky & diaphoretic - fell pt transferred by ambulance to ER - given steroids/advised to take BENADRYL 94 degrees x 24 degrees swelling decreased some redness left on 8/2109.
terrible diarrhea; This is a spontaneous report received from a non-contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2 NOS), as dose number unknown (booster), single (batch/lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete (unknown manufacturer) for COVID-19 immunization. The following information was reported: DIARRHOEA (non-serious), outcome "unknown" described as "terrible diarrhea."  Additional information: The consumer, got a Pfizer Covid-19 booster shot on Thursday and she got terrible diarrhea. She wanted to report this and wanted to know if this is the side effects of the booster shot. There is an administration.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Diarrhea. Very loose watery stools and cramping. Mild soreness in the arms, fatigue, aches but primarily the diarrhea has been the worst. I am still experiencing chronic diarrhea and have yet to have a normal stool. I do not have this problem.
Swelling; redness; hot; pain; This is a spontaneous report from a contactable nurse via a sales representative. A patient of unspecified age and gender received first dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at SINGLE DOSE for immunization. The patient's medical history and concomitant medications were not reported. On 15Jan2021, the patient experienced swelling, redness, hot, pain. Event took place after use of product. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
1/7/22 1431  Son brought pt to ED, stated his family has all tested positive for COVID and pt has had diarrhea, cough, and fatigue x 1 week. Pt is vaccinated and denies any other symptoms. 1448 Per nurse at first watch, son informed nurse he was taking him home; patient dismissed at this time.  No further information is available.
From the start of the shots, I developed this rash that I am still dealing with.  After closer examination, I believe it to possibly be monkey pox.  The way that people react to seeing it is also very apparent.  I am also suffering with tinnitus that was attempted to be treated with hearing aids, which have done absolutely nothing!  I have photos that I have taken of my skin after every injection!  And after the initial outbreak, the rash turns dark!  I've been trying to find creams to try to clear my skin and it's still discolored!  If this is monkey pox, Moderna is responsible for me having it!
Narrative: ER Course: I examined this patient, after I obtained a history. Given that she developed a rash and itching, was felt that she was having a mild reaction to the COVID-19 vaccine. The patient was concerned because she has had more severe allergic reactions in the past, and they start like this and become worse without treatment. The patient was given IV famotidine and diphenhydramine. She was also given IV Solu-Medrol. The patient was monitored in the emergency department and she indicated that she felt better. She did not have any swelling of her face, throat, or tongue. She did not have any difficulty breathing. Her vital signs were stable
Patient is reporting that she had sever flu type symptoms the 3 days following the dose of the vaccine. Reported that symptoms were so severe that she was unable to do anything other than lay around.
Initial report was reported by healthcare professional on 03- Dec-2013: A 53 year old male, medical history and concomitant medication were unknown, received dose of FLUZONE (Lot# UT4722BA) at left deltoid, on 23-Nov-2013. On 23-Nov-2013, patient experienced rash on arm which spread over entire body. Event was not resolved at the time of report. Documents held by sender: none. Follow-up information received from a healthcare professional on 16-Jan-2014: The patient had in fact received a dose of FLUZONE ID. He saw a dermatologist and, after using steroids, his rash was resolved in "2" weeks i.e. around 20-Dec-2013. Upon internal review, this case was assessed as serious, i.e. as an important medical event.
Began 04/07-08/2011 Irritable, fussy, multiple episodes of emesis with bilious and some projectile vomiting, decreased urine output.
Information has been received from a pharmacist concerning a 50 year old male with no medical history or drugs allergies, who on 15-SEP-2009 was vaccinated with a 0.5 mL first dose of PNEUMOVAX 23 (lot # 663888/0627Y), intramuscularly. There was no concomitant medication. The patient developed soreness at the injection site of the left upper arm within a few hours of receiving the PNEUMOVAX 23. On 17-SEP-2009, the patient developed a red, tender area about 3 inches in size near the injection site. No laboratories studies performed. The patient sought medical attention through a phone call to his pharmacist. At the time of this report the patient had not recovered. Follow up information received from a pharmacist indicated that on 15-SEP-2009 the patient received the dose of PNEUMOVAX 23 (lot # 663888/0627Y), intramuscularly in the left arm. On the same date the patient was also vaccinated with a dose of FLUVIRIN (lot # 9784IPI) intramuscularly in the left arm. The patient developed soreness at the injection site of his left upper arm, red and tenderness at injection site were also developed by the patient. The patient's outcome is unknown. Follow up information has been received form the pharmacist who reported the patient's outcome as not recovered. No further information is available.
Myalgia & Arthralgia Narrative:  dose 2- severe deep left shoulder joint pain and  radiates to right side on occasion;generalized aches, fatigue, and  continuous runny nose  Other Relevant History:
Headache, Myalgia, Arthralgia & NauseaVomiting Narrative:  Other Relevant History:
Fever of 102 F  Fatigue Body aches  started 9am 03/16/2021 lasted 36 hours until 9pm 03/17/2021
Shot went in great.  That night of the shot I started having pain in the arm around 9:00, around 10:30 I felt chills, flu like, took advil. Next morning I stayed in bed all day, I had 99.9 temp, mine is usually 97.7, Diarrhea, also, crazy dream, stayed in bed all day, took advil,.  Thursday, got up, went back to bed,  dizzy, head ache, no temp.  Friday, got up head ache,  took advil, Saturday, got up had head ache, dizzy, went to bed, got back up got the chills, went into take show, noticed a rash on my arm, at sight where shot given, tender to the touch. Went in to Urgent care, told redness was high sensitivity, not celulitus, but to watch.  Today Sunday, I feel great.
Swollen hurting foot tendons (podiatrist 1/19) F.P. Dr (2/2); intense pain intermittently approximately 4 months different area at a time, even brain! Infectious dis. Dr. (3/25 & 4/22) F.P. (3/16 & 6/21); foot x ray (6/22), foot MRI (7/19) pain tapered off, still in feet.
PNEUMOVAX shot given afternoon of 3/14/12, pt came in next morning of 3/15 with swollen elbow & forearm. No reaction at injection site, but edema of left elbow, swollen, feverish.
Had immunizations on 06/02/06, overnight decreased temp and color changes. Next AM hypothermic with decreased pulse/BP on arrival to ED pulseless. Resuscitated req'd intubation x 2 days. 8/9/06 received medical records from hospital which reveal patient admitted 6/3/06 w/diagnosis of shock after presenting to ER with hypothermia (although temp was 103.6), apnea & was pulseless. Successfully resuscitated & remained intubated in PICU for 4 days & received multiple fluid boluses & antibiotics.  Remained hypothermic for 2 days & apnea resolved with hypothermia.  Genetics were consulted & further labs were ordered.  Endocrine consulted for low cortisol.  ID also consulted & suggested possible pertussis reaction.  D/C to home on apnea monitor.  PMH includes 29 wk preemie w/retinopathy of prematurity, GERD, PDA s/p closure, anemia & UTI./ss Follow-up: Called pediatrician at midnite and asked if I should go to emergency. The Doctor told her no - that he gets calls all the time about these immunization and that pt would be fine. Mom asked if she should bring him in for fluids because he missed the last 3 feeds. Pediatrician said no he will be fine until the morning. The next morning mom could not warm him up he was alert, looking around but couldn't warm him. She spoke with Doctor and told him I don't care if you think I am crazy but I am bringing him in. They told me they had an appt at 11:20 and to bring him in then. When got to Doctor's office. The nurse spent 20 minutes going in and out of room to get thermometers because she thought they weren't working. Mom said because he is too cold. They sent Doctor in and rectal temp was 91 degrees and states O2 level were in the 80's. And Doctor said he looks to good to be experiencing this and sent her to the ER. alone in her private car. When she got to ER - he was full blown cardiac and pulmonary arrest. And 89 degrees not true in report which says 103 degrees. He was successfully resuscitated. Report after that is correct.
Migraine, chills, diarrhea, vomiting, sore muscles, fatigue. Weak
Cough; Cough; This is a spontaneous report from a contactable nurse (patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: EM9809 and Expiration date: not reported) via an unspecified route of administration, administered on the right arm on 11Feb2021 13:30 (at the age of 77 years old) as dose 1, single for COVID-19 immunisation. The patient's medical history included sinus pressure (coughs when raining; sinuses are bad), tree allergy, breast cancer, and arthritis. Concomitant medications included an unspecified injection for pain in the leg (arthritis) received two weeks before the first dose and an unspecified pill taken every night for breast cancer. The patient previously took amlodipine besilate (NORVASC) and dextropropoxyphene napsilate;paracetamol (DARVOCET) for unspecified indications and experienced drug allergy. On 12Feb2021, the patient experienced a cough. The patient had a dry cough but sometimes brings up clear sputum. The patient was not experiencing any crackles or wheezing. The outcome of the reported event was not recovered.  No follow-up attempts are possible. No further information is expected.
About 20 minutes after receiving the vaccine the client reported a slight swelling sensation or change in sensation in back of the throat. Client was given EPI 0.5 cc IM. Sensation resolved within 5 minutes. Client was observed for 30 minutes after and did not have any recurrence of Sx. Did not at any time have any other swelling, rash, SOB, or other symptoms.
GREAT LOSS OF MUSCLE IN ARMS AND LEGS; DIZZINESS; LOSS OF ENERGY (FELT TIRED); This spontaneous report received from a patient concerned a 68 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068 and expiry: 09-JUL-2021) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced great loss of muscle in arms and legs, dizziness, and loss of energy (felt tired). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from loss of energy (felt tired), great loss of muscle in arms and legs, and dizziness. This report was non-serious.
Client was vaccinated at an outreach clinic in a work site office. Client returned to vaccine area 30 minutes after vaccine was administerd. C/O itching all over with rash. No rash was noted upon exam, vital signs were stable and no symptoms of respiratory difficulty. Through interpreter client describes burning and itching under the skin in both arms. Vital signs were monitored for 30 minutes as symptoms of itching subsides. No rash was ever apparent. Client refused to see an MD. Advised to go to ER if itching returned or other symptoms developed.
Local reaction-no respiratory symptoms. Erythema and swelling at site measuring 4.5 cm in diameter with light ring erythema measuring 4.5 cm. No lymphadenopathy. No other weals. Tx'd with antihistamines.
Hot flashes, swelling of mouth and throat, fatigue, bloody nose, shaky, nausea, loss of appetite and taste, achy and pain and nerve aching, migraines
On the seventh day, the vaccination site began to itch mildly and became red. The redness intensified the eighth day and became mildly sore. The site of the inflammation was roughly about the same as a quarter. This is the ninth day and it has not grown or spread, but is itchy. It doesn't feel warm to the touch.
patient was given vaccine on 7/8/22 which had a refrigeration expiration date of 7/2/2022.
Sore throat, runny nose, nausea and diarrhea.  Soreness and tired. Arms are sore.
UNSPECIFIED ADVERSE EVENT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the patient experienced unspecified adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified adverse event was not reported. This report was non-serious. This case, involving the same patient is linked to 20211100495.
10mm firm moveable mass at site if IPV reported today, has been that way since immunized on 8/29/06 )L mid upper arm).
mom reports 12FEB95 7AM red rash, some raised on head, face & trunk; taken to MD for check; 13FEB inc in redness of rash, taken to family MD; MD felt rash r/t pertussis vax; pt to have no more pertussis; t101.9; rash completely gone 15FEB95
The next morning after the vaccine I woke up with my ears ringing, a bad headache, was really tired and not feeling well.  My arm was so super sore I couldnt lift it over my head.  On 3/10 the headache was still there but I  felt a little better.  But the ringing in my ears has been since day one and the headaches have been off and on as well since then also and on 3/25 I couldnt take it anymore so I went to see my PCP who referred me to an Audiologist but that appointment isnt until 4/29