chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacy technician and refers to a 27 year old female patient. The patient's pertinent medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 (dosage, route, lot number and expiration date were not reported) for prophylaxis. The pharmacy technician reported that on an unknown date, the patient received the second dose of GARDASIL 9 (dosage, route, lot number and expiration date were not reported) "1 year after first dose of GARDASIL 9"  (inappropriate schedule of drug administration). No adverse effects reported.
pt recv vax 19MAR97 & on 31MAR97 pt devel a rash consisting of ten chickenpox lesions;
TOOK THREE DOSES INCORRECTLY; This spontaneous case (PVX2019-2272) was received form a physician on 05-Sep-2019. It described a 25-years-old male consumer who "took three doses incorrectly" (PT: Product administration error), while being on Vivotif for typhoid prophylaxis.  Case report: The consumer took three doses of Vivotif incorrectly. The first dose was taken with alcohol on 30-Aug-2019, the second dose with food, and the third dose with a hot drink. The fourth dose was scheduled for today (05-Sep-2019) and he had not taken it yet.   Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took three doses incorrectly" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took three doses incorrectly" was considered as not applicable.
Pt rec tdap & MENACTRA in (rt) arm at 3:15 pm, walked out of rm immed. after, was standing at counter, stated she didn't feel good, and then fainted fell backwards about 3 mins after vaccines. Woke within 30 seconds & discharged to home.
04/06/2021 between 3:00 a.m. 9:45 a.m. Early morning hours at home experienced soreness in right arm where injected, chills, body aches, nausea, lightheaded, dizziness, fainted  and hit head on hall tree before hitting the floor.  When conscious saw tooth on floor beside me , bruises to chin and inside mouth, two front teeth pushed back in mouth. Called dentist emergency, then periodontist who called 911 when I became lightheaded with fluctuating blood pressure and heart rate.  Was taken by EMS to Medical Center. Seen by Dr. who diagnosed me with Vasovagal Near Syncope Collapse. Periodontist treatment plan includes 3 implants to replace/repair lost and displaced teeth..ongoing.
Employee received vaccine on afternoon of 12/22/2020 at clinic  She states she did have COVID previously in November.  She called in this morning with vomiting and now has fever of 101.9, headache, body aches,fever, productive cough, loss of appetite,  She has contacted her PCP for suggesntions.
Patient received 2nd dose of Pfizer COVID-19 vaccine on 4/1/2021. Vaccine given 09:35. She complained of tongue swelling and periorbital swelling. She was evaluated by Doctor and given BEnadryl 25 mg po x1 and Pepcid 20 mg po x1. She was observed for 30 min.
Erythematous macular rash from inject sites spreading down arms; wheezing bilaterally in lungs;
Shot administered at 3rd Party location on 10/2 at 6 PM.  Adverse affect noticed 10/5 in evening with irritation. Minor  swelling under tongue around noon on 10/6.  Extreme swelling of elbow on same arm as shot on 10/7.  Wnet to Dr on 10/8 around 2 pm - swollen elbow, no pain in joint, inflamation of tissues, hot to touch - not itchy, soreness in shoulder joint of same arm now.  Prescribed Augmentin, Mortin and ice.  If swelling persists on 10/9 Dr will consider draining elbow.
My daughter woke up at 2:00 am with a temp of 103.6. continued a fever on and off for two weeks. 5/22/2010 she started to vomit and had diarrhea. The diarrhea lasted for 4 days. 8 days after the injection she develped severe rash from head to toe. She has also been very irritable. Today is June 8, 2010 and still has a rash.
Per patient: I received the J&J covid vaccine on April 5th. The following day I was dizzy, tired, running a fever, and my injection site was very sore. I could not lift my arm above my head without being in pain. I was not able to eat anything the entire day. I attempted to eat some soup but threw it up. I woke up at 3am on Wednesday morning and drank some water but within 10mins I threw that up along with blood. At one point when I checked my temperature it was 104.8. By Wednesday afternoon I was still not able to eat anything but I was able to drink Gatorade. My fever did not break until Thursday afternoon. I was able to go back to work on Friday but my arm still hurt and was red and swollen. The injection site began to itch on Friday and continued all weekend. On Sunday my hand of the arm that had the injection got swollen for about an hour. It is now Tuesday of the week following my vaccine and I feel fine but my injection site is now purple.
No adverse effect; Administered improperly stored doses of Proquad; This spontaneous report was received from medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions or allergies were not provided. The patient's concomitant medication included sterile diluent (DILUENT MRK).  On 15-APR-2019, the patient was vaccinated with 1 dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), lot# R017628 (expiry date 18-DEC-2019) (frequency, strength, route, anatomical location were not provided) for prophylaxis (product storage error). The vaccine was stored at a temperature of -14 Celsius (C)  to -10 C (-11 C) for 30 minutes and also at -9 degree C to 8 degree C (-7.1 Celsius) for 45 minutes. There was no previous temperature excursion. The patient did not experience any adverse effects. The call was because of a data logger. No product quality complaint (PQC) was involved.  This is one of the several reports received from same reporter.; Sender's Comments:  US-009507513-1904USA009353: US-009507513-1904USA009841: US-009507513-1904USA009842: US-009507513-1904USA009841:
stiffness, sharp pain-both hands, primarily rt hand (comes & goes); nausea, especially w/empty stomach, occ vomiting, diarrhea, feverish;ears have tunnel feeling, gets quieter then louder;can valsalva -numbness in lt hand, rt middle finger
Intense muscle pain from neck to ankles (flu-like aching), headache, chills, severe fatigue. and injection site pain. Took 1 does of Baclofen (10 mg) which was prescribed for neck pain, but it did not help. Going home to try to get some sleep.
Case number PHEH2015US021056, is an initial spontaneous report received from a pharmacist on 16 Oct 2015. This report refers to a 17 year old male patient. Medical history and concomitant medication were not reported. The patient was inadvertently vaccinated with FLUCELVAX (batch number: 173988) intramuscularly at a dose of 0.5 ml on 14 Oct 2015. The case was reported as non-serious. No adverse event was reported following the maladministration
My husband woke up with a slight fever (99.4), feeling cold, headache and feeling "bad" all over.  I gave him 2 tylenol and he went back to sleep.  He fell asleep last night at around midnight, woke up at 10:00AM with symptoms, and then fell back asleep.  He recovered from Covid last month.  I looked up the dates for covid patients to get vaccine and it showed about the middle of this month. He missed his first appt. and I rescheduled for yesterday, 10/28/2021.  He was fine when he came home and even when he went to bed, but woke up sick this morning. I wonder if because his body has already fought off covid, If the vaccine has triggered the body's immune response?
On 3/4/02, dx'd chickenpox disease and Rx'd Benadryl.
Pt stated he had red, enlarged injection site as well as fever, chills, nausea, etc. - Said he could not get out of bed.
Participant wonders if she's having Long COVID-19 Tonsils became sore and started coughing a lot. They had me take a COVID-19 test and I was Positive so they sent me home. I rested and took OTC pain relievers and Nyquil. One week later I took a home COVID-19 test and was negative. I was left with a residual cough and that lasted between 5-6 weeks though. Started feeling bad again and took a home test and it was negative. My back became sensitive and I felt dull pains one morning. I went to work and was sitting down at my desk, my back started hurting really bad, it felt like someone was pounding on my back. I tried to get up but couldn't. After a little while I used all my strength to painfully get up, but couldn't stand up straight. I went to the ER where they did a CT scan, determined that I had a Lumbosacral sprain and gave me a muscle relaxer. Then they referred me to an Orthopedist. The Orthopedist past found SI Joint Inflammation. She gave me an Ortho belt to wear and prescribed Prednisone. I'll finish this prescription on 8/25/2022 and then I'm being given Meloxicam for 1 week. I was diagnosed with Spondylosis of Lumbar and Spine. I'm still feeling achy. My Dr. may send me to Physical Therapy soon. I'm wondering if I have Long Covid.
Fever 101-102 x 24 hrs, hard chills x 4 hrs, headache x 24 hrs, severe body aches x 24 hrs, severe injection site soreness x 24 hrs, agitation x 12 hrs, generalized malaise and fatigue x 48 hrs
In the evening I started to feel really tired and had some nasal congestion. I took a COVID-19 test that was negative. 2 days later I went to urgent care and was given a z-pack medication. A few days later I took a COVID-19 test that came back positive. By that time my symptoms had gotten worse I was severely congested, had body aches, and was very tired. I went to see my doctor, and my oxygen level was at 94.  I was prescribed Paxlovid. I had to stop taking it because I broke out in a rash. I am still having the same symptoms.
Fever (100.5); abdominal pain; aches; muscle aches; chills; This is a spontaneous report from a contactable healthcare professional who reported for herself. A 28-year-old female patient received second dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot number EL3248) via an unspecified route of administration 13:15 on 14Jan2021, at left arm, for Covid-19 immunization. The patient received first dose at left arm 03:15 PM on 22Dec2020. The patient's medical history included vertigo. The patient had no known allergies and no Covid-19 prior to vaccination. Concomitant medications included meclozine, montelukast, mometasone furoate (NASONEX), atomoxetine hydrochloride (STRATTERA), and levocetirizine dihydrochloride (XYZAL). 02:00 AM on 15Jan2021, the patient developed fever (100.5), abdominal pain, aches, muscle aches, chills. No treatment was received. The patient had not tested for Covid-19 after immunization. Outcome of the events was not resolved at the time of reporting. The reporter considered that the events were non-serious.
Redness around the injection site 1d after the injection, seen at the ER 2d after the injfection b/c of spreading redness. Per ER record, he had a 5x5cm area of circular erythema, nontender. Thought more likely to be allergic reaction, told to take Benadryl, but prescribed Keflex for possible cellulitis.
Moderna covid-19 vaccine EUA. Pain at injection site, pains on lifting injection arm next day. Diffuse muscle and joint pains next day. Extremely tired next day. Upset stomach next day. Peculiar feeling on the tongue - not burning just a weird sensation.
No adverse reactions noted. Pt was given Tdap inadvertently, mom reports no side effects other than the common pain at the site of injection. Pt was ordered Dtap and fail to administer.
The day of the vaccine she experienced a mild fever with slight dizziness and a headache.   The next evening she felt warm, clammy, dizzy and nauseous.  Since then she has exhibited increasing signs of paranoia with the following symptoms: confusion, memory problems, disorientation, memory time loss, depressed mood, difficulty concentrating, forgetfulness, impaired social skills, lack of pleasure, memory problems, personality change, poor concentration, slow thinking, emotional detachment, unusual behavior and lack of emotion.  10/15/2007 MR received for DOS 9/13-20/2007 for D/C DX:  Acute Psychosis-psychiatric. Organic Psychosis-not confirmed.  Seizures-not confirmed. Pt was transfered for seizure-like activity from a psychiatric facility where pt was receiving treatment for acute psychosis similar to paranoid schizophrenia.   HPI: Within a few days of receiving IM Typhoid vax pt began to have psychotic symptoms such as visual and auditory hallucinations and paranoia. Initially treated with medication as an outpatient, however no improvement was noted and pt was hospitalized at a psychiatric facility.  Pt developed seizures which consisted of shaking of all of the extremities.  Pt transfered to a medical facility where pt had 5 seizure episodes (one with urinary incontinence) followed by increased paranoia. Parent reporting significant developmental regression. Pt then transfered to current facility for higher level of care.  PE significant for child like answers to questions, abnormal speech prosody and decreased spontaneous speech.  Pt seems fatigued. Pt oriented x1.  Pupils large bil. Patellar reflexes 3+.  (+) Auditory and Visual hallucinations. Pt was d/c into care of her parent who will arrange for psychiatric re-admission.
I had no reaction after the 1st dose administered on January 26, 2021 other than a slightly sore arm. After the second dose on Febrary 16, 2021, I expereinced the following in the following order.  I did not feel better/normal until March 12. 101 fever for 24 hours, headache for days, chills, slight nausea, pain and aches all over and in joint areas, pain under shot arm in gland areas, black eyes and eye aches, divertiulitus event, brain fog - not being able to have sharp recall, and hives last 7 days.
bell's palsy Narrative:  Patient had history of Bell's Palsy prior to receiving Moderna vaccine. Sx after vaccination occurred on opposite side from previous episode and onset was 5 days after vaccination.
High fever 104F, 09/08/2010 to 09/10/2010 for a duration of 2 days.  Outcome is recovered/resolved.
Extreme stomach pains and felt like my kidneys were going to explode for about an hour. No action taken. Stayed very still in bed and tried to sleep.
Patient fainted the minute I administered flu vaccine (AFLURIA) to him. He regained consciousness immediately.
gets a flu; Initial information received on 15-Nov-2020 and live follow up processed together received on 03-Dec-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (consumer) via Social media.  This case involved an adult male patient for whom it was reported he gets a flu (Influenza), after receiving vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, unknown latency, the patient he gets a flu (Influenza).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome of the event of influenza was unknown.  There will be no information available on the batch number for this case.
pt recvd vax & lab eval revealed pos anti-HBs & pos surface antigen;
REDNESS AND INFLAMMATION OF UPPER ARM AROUND INJECTION SITE. NOTICED THE NEXT DAY AND WAS CLEARING BY THE SECOND DAY.
I have been having excessive blood clots; menstrual cycle has been off. I have had uterine fibroids that have developed. I have pre-existing ovarian cysts and I have had surgery that in July 2018. Need to remove endometrial polyp. No treatment right now.
Swelling in the left arm, rash, bruising, skin felt tight and hot. Swelling progressed up towards the left side of my neck and the left side of my face. Left side of my face swelled and developed the same rash, skin tightening and hot to the touch. Also, the upper lip is numb (left side).
This spontaneous report was received from a Certified Medical Assistant (C.M.A.) regarding a 4 year old patient of unspecified gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-JUL-2016, the patient was vaccinated with improperly stored PROQUAD (lot # L050910, expiry date 14-JUN-2017) dosing regimen unknown. Call was because of a data logger. It was reported that the vaccine administered was subjected to temperature excursion of 23 degree Celsius for a time frame of 1 hour and 29 minutes. The vaccine was not subjected to any previous temperature excursion. No adverse effect was reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
MOTHER CALLED 6/24/08 TO REPORT CHILD HAS A "RASH ON HER STOMACH, BACK AND NECK". RAN FEVER ON 6/20/08 THEN RASH DEVELOPED 6/23/08 ON NECK & SPREAD TO BACK & STOMACH THIS MORNING AND ALMOST RESOLVED BY 3?30 PM 6/24/08 & NO FEVER SINCE 6/21/08.
Experienced Sudden Cardiac Death, approximately 20 times between initial cardiac death and being placed on ECMO.  I was luckily standing next a friend who happened to know CPR.  I had no symptoms prior to this, I simply collapsed.  I have no memory of the events.  I was transported to local Medical Center, then to another facility.  I was intubated, then placed on ECMO.  After 2.5 days I was taken off ECMO, and 2 days after that I was fitted with a SICD.  I was administered a battery tests, including tox screen, MRI, CAT scan, echocardiogram.  Full list of tests is available via my doctor.
Mom called states pt began last nite w/white sores in mouth (on gums, under tongue) when to school today on field trip (mom went also) pt began to feel feverish & listless mom felt poss rxn to MMR 1 mo ago; Mom told MD now;
blood pressure was elevated about 140-150's/80-90's; headaches; This is a spontaneous report from Pfizer-sponsored program from a contactable other healthcare professional and consumer (patient). A 63-year-old female patient received tofacitinib citrate (XELJANZ XR), via an unspecified route of administration from 28Sep2020 (Batch/Lot number was not reported) to an unspecified date, at 11 mg for an unspecified indication and BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date not reported), via an unspecified route of administration on Dec2020 as a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included unspecified covid vaccines. Side effects reported includes headaches and increased blood pressure. Patient stated from end of Dec to end of Feb, blood pressure was elevated about 140-150's/80-90's. Only thing that changes was she got her Covid vaccines in Dec. States now her blood pressure is back to normal. The action taken in response to the events for tofacitinib citrate was unknown. The outcome of event blood pressure was elevated was recovered while for other events was unknown.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: COVID-19 vaccine (BNT162B2) was added as a co-suspect drug.
Headache and blurred vision including flashes of light around 8:00 pm. Loss of sensation in right hand in conjunction with previous symptoms around 10:00 pm. Slight disorientation as well. Aside from headache, symptoms cleared between 10:20 and 10:30pm.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On 09-AUG-2016, the patient was vaccinated with the first dose of GARDASIL 9 injection, intramuscularly (dose, lot # and expiry date were not reported) for prophylaxis. Subseqently, the patient showed up in the pharmacy on 28-DEC-2016, to be administered the second dose of GARDASIL 9. No adverse effects were reported. Additional information is not expected as no consent to contact the physician was given.
area around the injection site became red; area around the Injection site became hot; area around the injection site became itchy; area around the Injection site became swollen; lumps on and under the clavical that are super super sensative; Little bumps when touched lightly around the lymph nodes; arm was sore; A spontaneous report was received from a consumer concerning a 59 year-old, female patient who received Moderna's COVID-19 vaccine and experienced sore arm, injection site "red, hot, swollen, and itchy", and lumps on and under the clavicle.   The patient's medical history was not provided. Concomitant medication includes a multivitamin.    On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 28 Dec 2020, the patient reported having a sore arm for 2-3 days. On 03 Jan 2021, the patient's injection site became red, hot, swollen, and itchy. The symptoms did not worsen, but are ongoing and have not gotten better. The patient also reported lumps on and under the clavicle on the left side, around the lymph nodes that are "super, super sensitive". Treatment included ibuprofen.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events, sore arm, injection site "red, hot, swollen, and itchy", and lumps on and under the clavicle was considered not recovered/not resolved; Reporter's Comments: This case concerns a 59-year-old female who had nonserious events of unexpected injection site warmth and expected injection site erythema, injection site pain, injection site swelling, injection site pruritus, lymphadenopathy, and lymph node pain. Treated with ibuprofen. Event onset occurred the same day as the first dose of mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
The RPH administered the flu vaccine. Within 5 minutes after having a flu shot, patient fainted while he was at the pharmacy waiting area. The wife called 911 immediately. The paramedic team arrived within 15 minutes, took his blood pressure (90 palpitations). The paramedic team informed the patient that he would be fine; however, they must take him to the ER to monitor his blood pressure condition and give I.V. Prior to administering the flu vaccine, patient report to RPH that he has not had any allergy conditions to eggs, any medications and flu shots. Patient was in good health condition prior to having the flu shot. Patient did express after the fact that he was afraid of needles, and complained that he was dizzy and nausea. Patient had one dose (0.5 ml) of FLULAVAL 2013/2014, IM route, Left, Lot # HK75L, expiration date: 06/2014.