chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The titers came back positive for measles and rubella but negative for mumps/mumps was below 9 AU per milliliter; Antibody test negative; the patient's father has expressed doubt on if the vaccine was actually administered/ lot number and expiration date he looked up and found as diluent; This spontaneous report as received from a consumer refers to his 3-year-old son. No information regarding the patient's medical history, concomitant medications and concurrent conditions was provided. On 17-MAY-2019, the patient should be vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) to prevent measles, mumps, and rubella but instead he received only sterile diluent, in the right deltoid, lot # M034781 has been verified to be a valid lot number, expiration date reported as 29-APR-2020, but upon internal validation established as 11-APR-2019 (dose, frequency and route of administration were not reported). On 18-MAY-2019, the father took the patient to a different physician. At the appointment, it was noted that there was "no indication that any vaccine had been administered". On 29-MAY-2019, the patient had blood drawn to check for titers. The reporter stated that "all titers were flat out negative." On 17-JUN-2019, the patient had had blood drawn to check for titers for the second time and the results were negative. On the same visit, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, frequency, route of administration, lot# and expiration date was not reported) for prophylaxis. On 12-JUL-2019, the patient had blood drawn to confirm the titers and the result was: measles 268 arbitrary unit per milliliter (positive), mumps below 9 arbitrary unit per milliliter (negative) and rubella 4.24 index (unit not provided)(positive). The outcome of the events and causality assessment between suspect therapies and the events was not provided.
Case number PHEH2016US022864 is an initial spontaneous report received from nurse on 07 Sep 2016. This case refers to 2 year old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUCELVAX Quadrivalent (batch number: 185886) at a dose of 0.5 ml intramuscular on 07 Sep 2016. It was reported that, the patient was inadvertently given FLUCELVAX Quadrivalent. No adverse event was reported following this medication error (inappropriate age at vaccine administration).
Swelling to softball diameter within 8 hours of the administration of the vaccine.  By 36 hours later, the entire thigh/front half of the upper leg is red, hot, and swollen.
A pharmacist reported that a female pt received an injection of Pnu-Imune 23 on 11/14/01 and developed seizures the same day. The seizures persisted and the pt was hospitalized on 11/15/01. The reporter noted that the pt had been seizure-free for 3 years prior to the onset of the event. No further information was available at the date of this report.
Myocarditis- woke up with chest pain. Eval in ER and found to have abn ekg, elevated cardiac enzymes (trop 0.38, ck 634, mb 35.1, proBNP 328).
Dose 1 I had sore arm, fatigue 36hours. Body aches, chills, fever. Headache.  Dose 2 I had sore arm, fatigue over 80hrs, body a he's. Hot flashes, head ache, nausea. Vomiting, and palpations.
erythema induration & tenderness @ site; fever to 100- t101 @ home; cellulitis was clinical dx
arm swollen; arm was warm; didn't feel well for a long time; This spontaneous report as received from a consumer refers to a 71-year-old female patient.There was no information about the patient's medical history, concurrent conditions or concomitant medication.      On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (dose, route of administration, lot number and expiration date were not reported).         On an unknown date, the patient stated her arm was warm (feeling hot) and swollen and she "did not feel well for a long time (malaise)."  The patient reported she was taking diphenhydramine hydrochloride (BENADRYL) after reaction. No clarifying details were provided.  The outcome of peripheral swelling, malaise and feeling hot is unknown.  The causality assessment for the events was not reported.   This is one of several reports received from the same reporter; Sender's Comments:  US-009507513-2102USA008670:
Sore arm (Rt), pain going up neck, pain moving neck side to side, pain going across back.
Information has been received from a health professional concerning a 43 year old female who on 11/23/2004 was vaccinated with a dose of RECOMBIVAX HB "That evening' on 11/23/2004 the patient experienced disorientation and confusion. It was noted that "she called her son daddy" subsequently, in morning she was fine. It was reported that no other vaccines were administered, there were no new medications, and there was no past history of similar symptoms. The patient did not consult a physician or go  to the ER. No product quality complaint was involved. No additional information has been requested. This is a follow-up to report(s) from a health professional concerning a 43 year old female with hypertension and seasonal allergies, who on 23-NOV-2004 was vaccinated with RECOMBIVAX HB (Lot# 647987/0865P and "9510700"). "That evening," on 23-NOV-2004 the patient experienced disorientation and confusion. It was noted that "she called her son Daddy." Subsequently in the morning she was fine. It was reported that no other vaccines were administered, there were no new medications, and there was no past history of similar symptoms. The patient did not consult a physician or go to the ER. No product quality complaint was involved. Follow-up information from the consumer indicated that the patient felf disoriented, had a headache, and was slightly nauseated that evening that she received her first dose of vaccine. It was noted a second dose of RECOMBIVAX HB (Lot# 647987/0865P and"9510700") was administered intramuscularly in the left deltoid on 10-JAN-2005 and the patient had no difficulty.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunization; BNT162b2 (BNT162B2), on 07Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Mar2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
The pt experienced a pinpoint rash on trunk starting evening of 5/9/01. Fever starting on 5/10/01.
Small very itchy bumps appearing beginning last night. Last night they were under armpits, on right upper thigh. This morning they were on the back of my neck as well.  I have no history of allergy to anything and have read many accounts of this happening to others, after their Moderna or Pfizer vaccine
I been vaccinated since end of Feb started with congestion, headache, low grade fever escalated in to loss of taste, body aches, slight and diarrhea.
Presented to ED 11/6 for weakness, falls, and ongoing dysuria and was admitted for this. Found to have AKI likely due to bactrim and possibly unresolved UTI. ED visit to hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
After vaccination patient started having pain in her left arm to the point that she can not lift her left arm. She went to the doctor on 01/22/21 and received pain medication. Her doctor told her that may be the muscle bundle fiber is injured and gave her pain medication. As of 01/22/21 she still can not lift her arm and when she tries she gets too much pain. She has not left the sensation.
Location site:  severe swelling, Hard to the touch, rash from shoulder blade to elbow. Hard to raise arm. Warm to the touch.
Initial report received on Nov 23 2005 from a health care professional. A 15 year old female patient who was born with weakness on her right side had received an intra muscular injection of Menactra, lot number U1782AA, expiration date 2/11/2007, in the right deltoid on Oct 18 2005. The next day she had a deep aching bruise sensation in her right arm, third, fourth and fifth fingers on her right hand. She was seen by a neurologist and was treated with prednisone for five days. Her diagnosis was complex regional pain syndrome with reflex sympathetic dystrophy. At the time of this report the patient had not recovered.
Began with low grade 99.2 fever Sunday, by today 1/25/12 fever up to 102.3, pinprick looking rash over chest/trunk, apparent sore throat (grabbing, refusing solids) tiredness, crankiness, running nose. Contacted doctor to confirm symptoms of vaccine reaction, watchful waiting for now as I didn't want to take her out & expose her to more germs when would be home treatment anyway.
This child received the adult Pfizer vaccine dose in error instead of the pediatric Pfizer dose.
WENT TO GIVE PATIENT INJECTION AND NEEDLE/SYRINGE SEPERATED.  NOTIFIED PATIENT THAT MAJORITY OF INJECTION DID NOT REACH TARGET AND THAT A 2ND INJECTION WOULD BE NEEDED FOR DOSE 1.  PATIENT AGREED TO RECEIVE A 2ND 1ST INJECTION, TOLERATED IT FINE AND LEFT THE PHARMACY AFTER 15 MINUTES POST INJECTION.
hurt all over, feverish, flu like symptoms. Slept most of the second day. Felt better the second day.
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Evening vaccine received patient began to notice swelling, redness, and pain at injection site - all three symptoms increasingly became worse through the night. Patient described color was almost purple at injection site and the pain radiated up to shoulder and down below elbow. The next morning (2/10) the patient noticed the swelling and redness had moved to the underside of her arm (underside of injection site). Monday (2/11) the swelling and redness had decreased, but the injection site remained hot to the touch. The patient stated that she took aspirin to alleviate the pain and applied a cold compress to the injection site.
pt awoke 9FEB94, pain in hands, wrist, shoulder, sharp pain in head, rt knee/foot very painful-difficulty walking downstairs;drove to clinic where dx w/sudden onset of arthritis & new onset diabetes dx diabetes mellitus tx w/cortisone
Red oblonged indurated patch with swelling in right arm (asymmetrical to left arm) swelling spread down arm toward elbow. Tender to palpation and warm to touch. Prescription for KEFLEX to treat cellulitis 8/11th-15th.
pentacel not mixed right pentacel  (green top vial ) was mixed with sterile diluent and not the liquid Hib (blue top vial)  patients mom was notified.  there wasn't any adverse events
Left arm redness, pain, swelling, numbness, tingling, which radiated to her left leg.
Patient received flu shot at PCP office on 9/17/2014.  Later that evening she experienced sudden symptoms including chills on and off, generalized weakness, and fever (99.9). Patient woke up in the middle of the night to use the bathroom, but could not get out of bed to do so. She tried a few times and then became scared and laid back down. On 9/18/2014 the patient presents to the emergency because her symptoms are persistent.
The first night symptoms included insomnia, joint pain, stomach cramps, sweats and general malaise that continued until the following evening. Over the next six days low energy, headaches and brain fog. Then random muscle twitches began. One week after the injection frequent muscle twitches up to 30 through the night that would wake me from sleeping. The next few days significant increase in heart rate upon standing or with any physical activity. Increased blood pressure up to 179/108 with headache. Heart Palpitations  became almost constant with strong and painful skipped beats and bounding heart rate which caused chest pain, light headedness and shortness of breath. Within the following week I was experiencing gastric reflux, bloating and pale stools.  Tingling and pain in feet and lower legs.
Fever; Chills; Headache; Body aches; Extreme fatigue; This is a spontaneous report from a contactable other healthcare professional. A 62-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283; expiry date: unknown) via an unspecified route of administration, on 12Jan2021 at 10:00 in the left arm, at a single dose, for COVID-19 immunization. Relevant medical history included rheumatoid arthritis, allergic rhinitis, sulfonamide allergy, and allergy to capsicum. Concomitant medications included adalimumab (HUMIRA), hydroxychloroquine, leflunomide and other unspecified medications. The patient previously received first dose of (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: FL0140; expiry date: unknown) on 22Dec2020 at 15:00 in the left arm, for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 12Jan2021, at 23:00 (on the same day after the injection), the patient experienced fever, chills, headache, body aches, and extreme fatigue. The patient did not receive treatment for the events. The patient was recovering from the events. The patient has not been tested for COVID-19 since vaccination.
Pt reports "weird sensation" on left side of neck and then her entire face went numb. She then reports feeling the "weird sensation" on the right side of her neck. She did not treat this and reports that it went away on its own after about 15 minutes.
Patient reported redness and soreness at the injection site, as well as joint pain throughout her body. She also reported nausea. These symptoms resolved 3 days after onset.
Inappropriate route of vaccination; she had a sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), in Jan2023 as dose number unknown, single (Batch/Lot number: unknown) subcutaneous for immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing); "Rheumatoid Arthritis" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "elevated cholesterol reported" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset Jan2023, outcome "unknown", described as "Inappropriate route of vaccination"; PAIN IN EXTREMITY (non-serious) with onset 2023, outcome "recovered", described as "she had a sore arm". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The reporter considered the event as caused by suspect product. A patient reported in market research that she had a sore arm for about one day after her pneumococcal pneumonia vaccine in Jan2023.   The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Pt presented to clinic on 8/22/22 to report adverse reaction to monkeypox vaccine given on 8/15/22 to left lower forearm. This nurse measured erythema skin reaction and it was 3.5 cm in diameter across injection site with a hard induration of 1.3 cm in the center. Pt stated that site was itchy but denied any other symptoms or reactions.
Information has been received from a registered nurse concerning a 3 year old white male with no pre-existing allergies, birth defects, or medical conditions, who on 05-APR-2005 was vaccinated IM in the right leg with a first dose of varicella virus vaccine live (Oka/Merck) (Lot # 649446/0651P). On 10-JUL-2007 the patient was diagnosed with varicella. There were no diagnostic studies performed. There was no illness at the time of vaccination. There were no adverse events following prior vaccinations. The outcome was reported as recovered as of 26-JUL-2007. There was no product quality complaint. This is one report of several from the same source. No additional information is expected.
I had Covid infection in March 2020 and have had symptoms since then that have not resolved.  Before the vaccine, I had symptoms of headaches, dizziness, fever, chronic infection, brain fog, cough , night sweats and shortness of breath.  After getting  the vaccine, these symptoms have continued and have not resolved.  Over time, these symptoms have not improved and have actually worsen.  I been on and off antibiotics of Doxycycline, Azithromycin, and  Augmentin.  I would run fever and high WBC count and the doctors can not find the orgin of the infection.   I've had several rounds of Prednisone and  Medrol dose pack. I would feel better with the medications then  fall sick again.   I have been out of work for 2 months.   I've had many tests and blood work and nothing signficant as to why my Covid symptoms have not resolved.
Numbness of both hands, increasing to near paralysis numbness of both feet increasing to near paralysis extreme weakness dysuria vision changes
Fainted 20 min after vaccine, after the waiting period waiting to check out.  Vitals were taken and  odserved for another 20 min. Has been ok since. No additional symptoms.
One week after injection, itchy, red rash on deltoid surrounding injection site was noticed, in addition to supraclavicular lymphadenopathy extending up neck nodes.  No axillary lymphadenopathy noted.  Rash is subsiding, lymphadenopathy remains.  Otherwise feel normal.
Patient reported having soreness, redness and swelling at injection site in Right buttocks area.  Came to emergency room for treatment.  Diagnosed with cellulitis for abscess at injection site and treated with antibiotics.
Rash on face - continuing to spread over entire face since injection - today is October 16th
started to experience tinnitus; This case was reported by a consumer via call center representative and described the occurrence of tinnitus in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included tinnitus (had a history of tinnitus which had resolved).   On 11th March 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced tinnitus. On an unknown date, the outcome of the tinnitus was unknown.   It was unknown if the reporter considered the tinnitus to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in right arm and within a week he started to experience tinnitus.  The tinnitus was affecting both the ears and thougth got the Shingrix vaccine in his right arm. The reporter consented to follow up.
Starting 9/24 symptoms included aching and malaise and feeling of being sick, with scratchy throat.  9/25/09 I started itching on head and groin area.  9/26/09 Hives startd on head, groin, hands, elbows, knees, thighs feet. Palms and soles of feet were affected as well.  Benedryl 75mg. did not help, nor did periactin or Zyrtec. Dr. prescribed hydroxyz pam 25 mg, which did not help, bud 75 mg. was able to control symptoms. MD prescribed Prednisone in dosage amounts and gave steroid shot as well.   I am on last day of prednisone and still have reactive skin to the touch and take the hydroxyz pam in order to sleep because I still have itching.  The itching was very intense and my right hand swelled to double its size.  Today is the 8th of October and I am not completely over the reaction.
Patient had PCV 13 done on 7/8/2015, then has localized swelling, erythema, pain, and itching. Patient had fever with temp 39 degrees C. Improved on 7/11/2015.
felt extreme tiredness; This is a spontaneous report received from a contactable consumer (the patient) from a Pfizer-sponsored Program. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on 09Mar2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the vaccine (09Mar2021) and felt extreme tiredness (Mar2021). This day he's tired and then a moment later he's not. He asked if this was normal. He wanted to know because his second dose will be (30Mar2021) and he was planning not to have it if that's what was going happen again. The outcome of the event was unknown.     Information on Lot/Batch number has been requested.
really really sick; Like a really bad flu; dizzy; Fever of temperature 101; Terrible headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (really really sick), INFLUENZA LIKE ILLNESS (Like a really bad flu), DIZZINESS (dizzy), PYREXIA (Fever of temperature 101) and HEADACHE (Terrible headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (really really sick), INFLUENZA LIKE ILLNESS (Like a really bad flu), DIZZINESS (dizzy), PYREXIA (Fever of temperature 101) and HEADACHE (Terrible headache). At the time of the report, ILLNESS (really really sick), INFLUENZA LIKE ILLNESS (Like a really bad flu), DIZZINESS (dizzy), PYREXIA (Fever of temperature 101) and HEADACHE (Terrible headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) fever of temperature 101.         No concomitant medications were reported.  No treatment medications were reported.  The patient states she had no symptoms after the first two shots.   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow up received : It contains No New Information.
Developed redness and swelling 24 hours after administration that rapidly spread. Exam was concerning for cellulitis. Started on KEFLEX.