chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received PNEUMOVAX vaccine on 3/11/09. contacted outpatient primary care clinic on 3/30/09 with the following - c/o- non-productive cough with shortness of breath x 2w the evening after he got his PNEUMOVAX. He states he is slightly short of breath now. Denies chest pain. He has hx of MI 2yr ago with placement of 1 stent. Abdomen is tight and he states his bowels are moving regularly.  No pedal edema. He has gained 3.9 pounds since 3-11-09 with his report of eating the same amount of food. He states he has a scratchy throat and some cough left. BP 161/117, P-117 with retake 154/118, 84.
01/04/22 presents to ED for "worsening shortness of breath, productive cough of yellow sputum". PMHx of "morbid obesity, hypertension, diabetes mellitus, sleep apnea"
A day after receiving the Pfizer booster shot he began to get swelling in his legs and thighs.  His scrotum also swelled up.  The swelling has made walking, sitting, dressing and using the toilet very challenging.  The swelling in his scrotum area is beginning to slowly lessen.  His thighs continue to intermittently swell up and become hot and heavy and painful.
Magnet sticks to site of injection; This is a spontaneous report received from a contactable consumer (patient's family members). The consumer reported for family members. This report is for 3 of 5 (reporting on the women).   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not provided), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Reporter was discussing how a magnet sticks to her injection site, at which time she mentioned that this happened to other people. Report 3 was caller reporting on the women. Reporter stated that she had a lot of family members who had a magnet stick to their site of injection, and most of them, the family members that it sticks to, are female.  Follow-up attempts are needed. Information about batch/lot number is requested.
had fever of 103 despite APAP q 4hr;just before next APAP dose due, father reported child shook for 10-15 seconds then lost consciousness for approx 15min;
02/03/2020 16:00pm Pain developed in the left deltoid and arm, site of vaccine. Swelling of site was mild. No rash. Difficulty lifting arm, very painful to touch, difficulty removing clothing and difficulty sleeping due to arm pain.  02/04/2020 02:30am Pain worsened in left arm. Developed mouth ulcers which were unexpected and painful. Rigorous chills. Temp normal, 97.7 F. 02/05/2020 05:00am Extreme fatigue, continued pain in left arm and continued painful mouth ulcers. 02/06/2020 02:30am Woke up and symptoms resolved with the exception of arm pain which remained until 02/08/2020. 02/15/2020 05:00am Mild left arm pain at site returned for duration of the day and then resolved by bedtime. 02/17/2020 04:00am 2 inch x 3 inch non-raised rash/redness appeared left deltoid at vaccine site with no pain. Warm to touch.
Came to employee Health with localized red raised rash on left upper arm at site of varicella injection. Rash is comprised of 4-5 dime sized red raised areas. No vesicles or Fever. Temp 98.1. Employee states painful to touch and itchy.
Vomiting; general body pain; chills; fever; headache; abdominal pain; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 10Apr2021 at 11:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included gastroparesis. The patient did not receive any medication within two weeks of vaccination. The patient did not have allergies to medications, food, or other products. . The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number :Unknown) via an unspecified route of administration in the left arm on 20Mar2021 at 11:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 01:00 the patient experienced vomiting, body pain, chills, fever, headache and abdominal pain. No therapeutic measures were taken as a result of the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events vomiting, body pain, chills, fever, headache and abdominal pain was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Reports 1 hr after vaccine developed hives on his chest, +itching, no breathing problems.  Did not take medication, hives worsened day 2.  Resolved spontaneously on day 3. Advised patient receive J&J.
This is a spontaneous report from a contactable consumer (office manager) received via a sales representative. This office manager reported similar events for two patients. This is the first of two reports. A 14-years-old male patient of an unspecified ethnicity received TRUMENBA (Lot# M13066, exp date 30Sep2016), at 0.5 ml, single on 28Jan2016 and GARDASIL, on an unspecified date at an unspecified dose both via an unspecified route of administration on the left arm. The patient medical history and concomitant medications were not reported. The patient experienced swollen red arm, fever, chills and body aches all on 29Jan2016 with outcome of recovered after 2 days. The patient had not received any treatment. Follow-up (14APR2016): Follow-up attempts completed. No further information expected.
Pt was having swelling of the vaccinated arm from midway between her shoulder and elbow up to her shoulder. The swelling felt like fluid.
On Wednesday December 23, 2020, Employee  received the COVID-19 vaccine at 10:20am. Afterwards, she was told to set my phone to 15 minutes so the medical team could observe her . During this time she  felt very cold and anxious. but no reaction noticed at this time .  While driving home, she felt hot and cold and felt like I couldn?t get enough air also her  neck was completely red.  heart racing and beating so forcefully. It was a highly amplified pounding of my heart and I could hear it. at 10:51 hospital advised her to come back , At the hospital she told pharmacist that   " my face go numb from my forehead to my cheeks and jawline" . " I felt my neck get hot and was tingling. "   Diphenhydramine 50mg IM injection was administered  at 11:16am then patient observed for 60 minutes till patient back to normal .  There may have been an interaction with the Botox injections that emolypee  received on Monday December 14th,2020 at 12:30pm. that enhanced this reaction.
Pt recv vax on 10/20/98; on 11/15/98 pt exp shingles
This case was reported by a healthcare professional and described the occurrence of flu like symptoms in a 67-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). The subject's medical history included kidney transplant. Concurrent medical conditions included high cholesterol and hypertension. Concurrent medications included MYFORTIC, LIPITOR, LOPRESSOR, NORVASC and Unknown. On 30 September 2010 at 13:00 the subject received unspecified dose of FLULAVAL (.5 ml, unknown, left arm). On 30 September 2010, 7 hours after vaccination with FLULAVAL, the subject experienced flu like symptoms. The subject was given a rapid AB flu test and the results were negative. Her infectious disease physician diagnosed her symptoms as a reaction to the FLULAVAL vaccine. The subject was treated as if she had a staph infection; she was given steroids and antibiotics. At the time of reporting the flu like symptoms improved. The healthcare professional considered the event was probably related to vaccination with FLULAVAL. Follow-up received from the reporting healthcare professional on 26 October 2010: The healthcare professional reported the diagnosis per subject as "reaction to influenza vaccination" which resolved on 08 October 2010 and was not considered serious by the reporter. The reporter stated that "health care provider initiated BACTRIM DS...for possible cellulitis and BACTROBAN subject's oncologist D/C". The event of possible cellulitis was assessed as medically serious by GSK. The onset date and outcome of possible cellulitis was not specified. It was unknown whether the events could have been associated with any other cause.
Information has been received from a medical assistant concerning a 4 year old female patient with no pertinent medical history and no known allergies who on 20-JUL-2009 was vaccinated SQ with a 0.5 ml dose of VARIVAX (Merck) (lot number ___/0265Y). Secondary suspect therapy included MMR II vaccine (MSD, lot number___/0427Y). On 26-JUL-2009 the patient developed rash all over her body. Then the rash disappeared and hives appeared (date unspecified). The patient was treated with BENADRYL (dose and duration not reported). The patient went to the office for medical attention. There was no lab studies performed. At the time of the report, the patient's status was recovering. Additional information has been requested.
1000 pt received vaccine in Rt arm. 1012 pt c/o "tingling" in rt arm, medicated with Benadryl 25mg PO and observed for additional time. Pt ready to go and was released with husband driving.
Guillain-Barre Syndrome. Within 24 hours of receiving HPV shot, patient experienced headache and extreme fatigue and weakness. Muscle weakness began in legs and progressed to arms, head and neck. Tingling in hands and feet. Intense muscle pain in thighs, hips, and arms. By ninth day, patient's facial muscles were drooping, experiencing rapid heartbeat and dragging right foot when trying to walk. By end of week 2 muscle function had returned and patient was recovering.  Extreme fatigue still remains. 7/10/07-records received-Seen in PCP office with 3 day C/O fatigue and bilateral leg pain. Tingling sensation in feet when she stands. Walks normally. Headache comes and goes. No numbness or tingling in hands. PE: sensation intact on both feet. Assessment:fatigue, leg pain and numbness in feet. At mom's request referred to neurologist for evaluation of Gullain Barre syndrome.  8/21/07-records received from facility for DOS 7/25-7/26/07 DC DX: Guillain-Barre syndrome.  Symptoms began approximately 5 weeks ago after receiving 3rd HPV vaccine. Began to experience generalized fatigue. Progressed to numbness and tingling sensations at tips of fingers and toes and progressed proximally. Low back pain and hip pain. Symptoms after 2 weeks began to improve and she went on a trip. Returned with profound fatigue and worsening paresthesias on her feet. Treated with IVIG. 2/26/08-After follow up with the patient's neurologist, the condition was found to not be GBS.
Got "really sick" after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got "really sick" after the second dose) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Got "really sick" after the second dose). At the time of the report, ILLNESS (Got "really sick" after the second dose) outcome was unknown.            No concomitant medication information was provided  No treatment medication information was provided
Patient was vaccinated on 1/26/21 and 2/16/21, so was fully vaccinated when testing positive for COVID-19 on 9/27/21.
Low fever, chills, slight aches in joints... sudden onset, reminded me of flu.  (Pain at injection site was expected!)
Pt developed urticaria over entire body 6 days post immunization of MMR, DTaP, HIB, IPV. Tx consisted of antihistamines.
Pt developed fever with vaccines, then admitted to hospital 2 days later with fever, weakness (weak cry), tachypnea, + decreased perfusion (mottled appearance).  All labs (Blood cult, CSF culture, urine cult, Influenza + RSV) negative.  Of note, another child admitted with similar Sx, same lot#.  9/24/09 ED records received service date 9/5/09. Assessment: None Provided - Labs only.  12/3/09 Discharge summary and medical records received for DOS 9/5-9/8.  Final DX: Vial illness C/O fever and fussiness. Decreased PO. S/P 2 month immunizations. Congestion. Tachypnea, grunting. Mucousy stools. Decreased cap refill.Flecks of blood in stool. D/C to home.  12/3/09 Discharge summary, hospital records received, service dates 9/5/09 to 9/8/09. Assessment: Viral illness. Presented by parents with concerns regarding fever, fussiness, and decreased oral intake. Congestion of 2 weeks duration, tachypnea, grunting cry. Lethargic. Stools mucosy. Blood flecks in stool. Gassy. Abdoment distended. Hyperactive bowel sounds. Bowel dysmotility.
Swollen lymph node under the arm of the injection site,   sore arm, severe headache, body ache
2nd dose given 3/26/2021.  Three days after the 2nd vaccine dose, patient had severe fatigue and some joint aches, this got much worse one week later with severe right hand synovitis, diffuse muscle and joint aches. He tried ibuprofen on 4/7/2021. this did not help. He came to see me 4/19 with severe pains. CBC, CMP, ESR, and CK levels were normal. CRP was elevated at 123. and I put him on a 12-days prednisone taper which made him feel better. He stopped that taper on May 1 and within one week his symptoms had returned in full force, this time with fever. I saw him again 5/14 and again he had elevated CRP level and also elevated ferritin level. other rheumatologic labs were normal. he still had right hand swelling and synovitis. He is miserable.
Patient reported that she got a red spotted rash on her arm that developed 48 hours post vaccination, that later turned into a sunburn like rash that later peeled. The rash was on both arms, both legs, her cheeks, and lower abdomen. Patient contacted primary care doctor via phone and was instructed to take Benadryl and an aveeno oatmeal bath. The rash resolved with no issues. The patient states she felt fine, she said she did not experience and itching, difficulty breathing/swallowing, or swelling of any kind.
1515: Patient had c/o feeling anxious approximately 15 minutes after vaccine dizziness.
0912: Pt honks horn, this RN immediately to car side. Pt reporting tachycardia. Pulse check 106, BP 154/81. Pt states it came on suddenly, no CP, no SOB, no tongue swelling, no numbness/tingling, no throat itching or swelling. Pt monitored by this RN. After about 5 minutes pt reports feeling like HR coming down, HR 88 BP recheck 160/82. Pt reports no allergies, no adverse reactions to any previous vaccines (has received flu shot and Tdap in last 4 months). Pt did eat this morning. 1000: Pt observed in car, feeling WNL. BP recheck 133/76. Escorted to bathroom by this RN w/out issue. Pt states she feels comfortable driving, symptoms have completely resolved.
After administered the Pfizer Comirnaty XBB 1.5 in the right deltoid writer injected 0.5ml in the left deltoid from a vial of Modrna Spikewav XBB 1.5 that was placed by the previous immunizer in the same basket as the Flulaval vial that was intended to be used instead.  Patient was stable for the watchful waiting period inside the pharmacy after injections administration and reported no adverse events other than injection site soreness upon follow up and reporting the incident to the patient via phone at 10:35pm same evening Oct 15, 2023.  Patient agreed to monitor for any adverse effects and report the same and to accept follow up from writer via phone and or email while he is travelling on a business trip outside the country following day via plan  Writer reported the incident to the pharmacy manager and owner same evening.
report hot flush w/ light headedness.   Had observer summons medical help.  reported never doing well w/ needles.  TX -reclined car seat.  removed mask- fresh air; emotional mask- fresh air; emotional support & water.   increased wait time.  Symptoms resolved / abted.  pt. drove off lot after 15 mins. wait time.
Red rash on chest, upper arms back, hoarse voice, swollen lips. Benadryl 50 mg IM 1 dose.
presented to the ER with complaints of abdominal pain. Found to have a ruptured appendix with intra-abdominal abscess, UTI, acute hypoxic respiratory failure related to bilateral aspiration pneumonia, and sepsis.    Principal Problem:   Perforated appendix POA: Unknown Active Problems:   Sepsis (CMS/HCC) (HCC) POA: Yes
Information has been received from a registered nurse concerning an 89 year old retired female who on 05-MAY-2006, at 12:00 p.m., was vaccinated with a first dose of Pneumovax 23 (lot # 651332/1049P). Subsequently the patient experienced cellulitis type reaction with redness, swelling and warmth from the elbow to shoulder. Body temperature measurement by mouth was 101. Laboratory data revealed a slightly elevated neutrophil count and decreased lymphocytes. The patient was treated with lactobacillus, 1 capsule twice daily for 17 days and amoxicillin (+) clavulanate potassium (AUGMENTIN), 500 mg twice daily for 10 days. On 09-MAY-2006, the patient recovered. Additional information has been requested.
did not have hot flashes for 3-4 days after getting the first dose; arm soreness; felling "drug out tired"; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (did not have hot flashes for 3-4 days after getting the first dose), PAIN IN EXTREMITY (arm soreness) and FATIGUE (felling "drug out tired") in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     The patient's past medical history included Hormone replacement therapy (four (4) years ago her doctor took her off hormone replacement therapy). Concurrent medical conditions included Hot flashes. Concomitant products included AMLODIPINE, SERTRALINE, LISINOPRIL, CARVEDILOL and ATORVASTATIN for an unknown indication.    On 31-Mar-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 THERAPEUTIC RESPONSE UNEXPECTED (did not have hot flashes for 3-4 days after getting the first dose), PAIN IN EXTREMITY (arm soreness) and FATIGUE (felling "drug out tired"). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (did not have hot flashes for 3-4 days after getting the first dose), PAIN IN EXTREMITY (arm soreness) and FATIGUE (felling "drug out tired") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The treatment information was unknown.   This case was linked to MOD-2021-270015 (Patient Link).
My arms are little numb and tender, now I have symptoms spreading up to my neck and above my left ear which is the shoulder I got my shot in; My arms are little numb and tender, now I have symptoms spreading up to my neck and above my left ear which is the shoulder I got my shot in; My left eye is like swollen; This is a spontaneous report from a contactable consumer.   A 58-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 06Aug2021 (vaccination at the age of 58 years) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient concomitant medications were not reported. consumer stated, "I only take like Tylenol or Ibuprofen, no I mean they were quite often, just not take daily, probably 3-4 days but that's over the counter." The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On06Aug2021, the patient had experienced my arms are little numb and tender, now I have symptoms spreading up to my neck and above my left ear which is the shoulder I got my shot in and my left eye is like swollen. At the time of reporting, the outcome of the events were not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Patient presented with a very red swollen arm, it was hot to the touch. Patient put ice on the spot and took antipyretics.
A 59-year-old male patient, with no illness at the time of vaccination, had received a left deltoid, intramuscular injection of Adacel, lot number C2759AA, on 03 July 2007. Ten days post-vaccination, he experienced "blurred vision and a wavy appearance in the left eye." The patient reported experiencing a similar episode 15 years prior following Hepatitis B vaccination. At that time, he was diagnosed with pars planitis. Other medications were none. The patient was referred to an eye clinic for evaluation. At the time of this report, the patient had not recovered.
The pt's mother states that the pt ha a rash on the right shoulder. The rash was described as redness with some white bumps extending distally, occurred immediately aft receiving the DTAP vax.
SEVERE PAIN INVOLVING ENTIRE DELTOID MUSCLE INTO WHICH PNEUMO VAC. WAS ADMINISTERED BEGINNING 5 HOURS AFTER IMMUNIZATION.  FEVER BUILDING TO 102 AT 24 HOURS; FEVER GONE AFTER 50 HOURS.  IMPROVEMENT IN MUSCLE PAIN AFTER 48 HOURS, BUT REDNESS AND SWELLING VISIBLE IN SPOTS EXTENDING FROM INJECTION SITE DOWN TO A 5"X 8" AREA IN THE LOWER PART OF THE MUSCLE.  TEATED WITH TYLENOL AND ALLEVE.
pt recv vax 24JAN97 & 5-6 hr p/vax pt exp chest tightness & minimal SOB but did not seek med treatment;sx improved & then resolved the next day;
Headache; Low grade fever; sore throat; EXTREME lethargy; This is a spontaneous report from a contactable consumer (reporting for herself). A 41-years-old female (Non-Pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: unknown, Expiry date: unknown), dose 1 via an unspecified route of administration, administered in left arm on 20Feb2021 09:30 as 1ST DOSE, SINGLE for covid-19 immunisation. Patient medical history included known allergies: penicillin from an unknown date and unknown if ongoing. Patient concomitant medications were not reported. It was stated that patient approaching two full weeks of side effect symptoms. On 21Feb2021, the patient experienced headache, low grade fever, sore throat, and extreme lethargy. I have been to the doctor twice. Negative for covid, strep and flu. AE resulted in doctor or other healthcare professional office/clinic visit Emergency room/department or urgent care. The patient did not receive any other vaccines within 4 weeks. The patient not received other medications within 2 weeks. Prior to vaccination, the patient was not diagnosed with covid. Post vaccination, the patient underwent lab tests and procedures which included nasal swab: negative on 01Mar2021. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Case number PHEH2012US015686 is an initial spontaneous report received from a healthcare professional on 07 Aug 2012. This case refers to an 18-year-old patient of unspecified gender. This patient was vaccinated only with MenCWY-135 liquid component of MENVEO (batch number: M10133) without being reconstituted with MenA component of MENVEO on 01 May 2012. Thus this patient received only partial dose of MENVEO. No adverse event was reported. No other information was available.