chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a Pfizer-sponsored program, XELSOURCE received from a contactable consumer. A 70-year-old female patient of an unspecified race/ethnicity received pneumococcal 13-val conj vac (dipht crm197 protein), via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient could not lift her arm without help on an unspecified date with outcome of not recovered.  Pfizer is Marketing Authorization Holder Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) has been submitted the same report to the regulatory authorities.
1/19/21 moderna vaccine; 1/27/21 9 days later-arm itching/red band across arm 3 in across 2 in wide (lasted 9 days)
1wk p/vax pt c/o upset stomach adm to hosp;19NOV96 w/ c/o weakness, unable to stand;pt in renal failure;
Rt arm turned red, itchy. No respiratory distress. BP 110/60 P80 sent to nurse's office in school, given 50 mg. BENADRYL IM (L) deltoid. Started to feel sleepy. Rested 30 minutes, parents arrived, V.S.S. BP 105/80. Went home with parents alert.  V.S.S.
I have a painful swollen armpit which I believe to be my lymph node on the side I received my injection (left). The lymph nodes by my throat are also swollen but not as large and painful as my armpit. It's quite painful  to move or raise my arm up or lay on that side. The pain constant and heat and cold compress brings little relief.  I also had the ?usual? symptoms of headache, fatigue and fever/chills  but I can tell they are beginning to subside today.
This spontaneous report as received from a pharmacy student refers to an approximately 57 year old at the time of event female patient. On 29-MAY-2014 the patient was vaccinated with ZOSTAVAX, (lot# and expiration date not provided) (dose not reported). In approximately 2014 the patient experienced postherpetic neuralgia after receiving ZOSTAVAX. The reporter stated that the patient reported the postherpetic neuralgia had occurred once monthly for an unspecified duration of time since receiving vaccine. The reporter stated that the patient experienced itching on her back (without a rash) as well as joint pain in her knees and fingers. It was reported that the patient was prescribed an unspecified antiviral medication on an unspecified day approximately 2 weeks ago. The patient did seek medical attention by visiting the office. The outcome of postherpetic neuralgia after receiving ZOSTAVAX, joint pain in her knees and fingers and itching on her back (without a rash) was unknown. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Diagnosed with COVID-19 on 01/18/21. Had previously received passive antibody therapy 01/18/21-01/26/21. Reviewed with client recommended to notify PCP. No adverse effects noted after administration on 03/01/2021.
the vaccine recepient died 9/9/2021, 2 weeks after receiving the J&J covid vaccine
Woke up at 5 AM shivering uncontrollably, weak, unable to move, sweating, feeling feverish, whole body aching. Needed to use heating pad for cold relief (no fever on thermometer). Took Tylenol; symptoms lasted 36 hours; passed out 2x upon standing up to use toilet. Dizzy, nauseous, blurry vision, headache, unable to eat, thirsty, very sleepy; took Tylenol every 6 hours for slight relief. Sick for 2 days but symptoms lessened after 36 hours. Terrible experience. Site of shot was the size of an orange, rash-wise, and very painful for 3 days.
Debilitating nerve pain in head, neck, front/back of torso, hips. Pain lasted 1-2 seconds, localized, occurring dozens of times per hour. Would occur in random places - chest, head, underarms, back, groin. I felt this warranted an ER visit, but rather tried my Gabapentin (prescribed for post-Covid headaches in December 2020) and Oxycodone (from my total knee replacement). Day 3, markedly improved. Only using Gabapentin on day 3.
Within an hour of the shot (took place on Wed 7/22), very cranky.  For next 48 hrs would not sleep more than 40min- an hour at a time for naps, and was up frequently at night crying. Fever rose to 101 (and that is with Tylenol as a pre-emptive strike). Refused bottle for days - seemed like it was "painful" to drink it. Also refused solid food.  Rash all over body.  It is now Sat 7/25 and he still has the rash, was still up last night, still very fussy, but has finally finished a full bottle today.  Fever is also down.
Initial information received on 10-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 38 years old female patient who experienced hives to both arms and entire back, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history and family history were not provided. The patient did not receive any concomitant medication. On 16-Oct-2017, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot 195212, expiry date 31 Mar 2017 via intramuscular route in the left deltoid. It was reported that Infection Control and Employee Health nurse called from a hospital to request FLUZONE QUADRIVALENT single-dose syringe ingredient list for allergen testing, on an unknown date patient experienced hives after immunization with that product 3 years in a row. Hives to both arms and entire back post-injection. The patient was not pregnant at the time of injection and had been eating eggs without any signs or symptoms of allergy. The patient requested the ingredient list for the FLUZONE for an allergist to test for potential allergies to those ingredients. Lab data was not provided. Final diagnosis was hives to both arms and entire back. Patient did not receive any treatment or physician visit or ED visit. The patient outcome is reported as Unknown for hives to both arms and entire back. List of documents held by sender- none.
No adverse event; The patient was administered with improperly stored VAQTA; This spontaneous report was received from a certified medical assistant (CMA) referring to a 12-month-old male patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 22-OCT-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S007770, expiration date: 24-JUL-2020, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to the temperature above 47 degrees Fahrenheit/9 degree Celsius (9.3 Celsius) for 23 minutes. The previous temperature excursion were at the temperature above 47 degrees Fahrenheit/9 degree Celsius (10.7 Celsius) for 33 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.7 Celsius) for 36 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.9 Celsius) for 15 minutes and at the temperature above 47 degrees Fahrenheit/9 degree Celsius (9 Celsius) for 12 minutes. The call was because of a data logger. No adverse event was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S007770; expirationdate: 24-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1910USA012749:
The morning after the vaccine I had a sore arm, severe headache, 120 HR and felt achy all over.  I took tylenol and felt a little better.  Sunday my eye irritation began in the right eye.  The right eye was hurting, had a little drainage and was severely swollen.  Conjuctivitis set up in the right eye and the right side of my head hurted really bad with the right eye area throbbing.  Contacted my PCP who prescribed eye drops for me.  My eye is still a little swollen and my head still feels really strange and still hurts a little on the right side.  I have consulted with the NP and the PCP who is currently monitoring the situation
Patient was admitted on 2/14/2022 for chief complaint of fatigue. Patient tested positive for Covid-19 as outpatient on 2/10/22 and has had symptoms for greater than 10 days prior to presentation. He had PCP appointment on day of presentation and was found to be hypoxic as well as lethargic and somewhat disoriented. Patient has been vaccinated for Covid-19 but has not had a booster dose. Patient was hypoxic in the EC and placed on supplemental O2. Patient was started on Decadron. He did received 1 dose of remdesivir but this was discontinued due to the duration of his symptoms and elevated LFTs. Patient remained stable on 3L nasal cannula during his hospitalization. He was evaluated for home O2 and qualified. He will continue Decadron at discharge to complete a 10 day course and will follow up with his PCP for continued weaning of his oxygen.
Vaccine given 7/26/2022 but expired 7/7/2022. No adverse event reported.
Patient was given Hep A and Typhoid when she started to feel light-headed. Patient was assisted to lie back and elevate feet and given an ice pack. Upon recovery, Menactra was administered to patient.
On the day after the vaccines, was already getting slightly swelled up and itching.  By Friday, around 5ish in the evening, both arms were really inflamed,  swelled up and hot to the touch.  He's never had adverse reactions to vaccines.  I took pictures.
I had sore throat cough headache and soreness in the arm.  Slight fever.
Pt recv vax on 9/3/98; on 9/5/98 pt exp fever (100), rash on arms, back, stomach w/ itching x overnight.
Received shots 9/21/06, 3 days later T102 and cough. Temp continued cough worsened. Went to ER. Admitted 10/28 thru 11/01/06. DX RUL Pneumonia. DC DX: Right upper lobe pneumonia. Respiratory distress, resolved. Admitted with C/O fever on admission 104 and shortness of breath.  RX with IV antibiotics.
Information has been received from a physician concerning a patient who was vaccinated with a 2 ml dose of rotavirus.  It was reported that the patient gagged because the "vaccine is too thin'.  Medical attention was sought.  There was no product quality complaint involved.  Additional information has been requested.
pt was given undiluted vaccination and is experiencing fever, chills, sweating, nausea and vomiting, headache, chest pain
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 042L20A) for COVID-19 vaccination. No Medical History information was reported. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received 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 VACCINATION SITE PAIN (pain at the injection site). At the time of the report, VACCINATION SITE PAIN (pain at the injection site) outcome was unknown. Not Provided. No concomitant and treatment information was reported by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow up document is received on 13-MAY-2021 and it doesn't have any new information.
The person is 17 years old and received the Janssen vaccine. No adverse effects occurred in the 15 minute observation period post the administration of the vaccine.
Patient described flu-like symptoms, (ST, nausea, myalgias) started less than 8 hours after vaccine administered. She sought medical attention at local ER and followed up at another medical center. She had no apparent lasting sequelae and symptoms were self-limited.
Began to feel ill and achy at 8:15 p.m.  2hours later running 100 degree temp. aching all over. Sleepless night with terrible joint pain.  Morning of 11/5 running 101.5 temp terrible joint pain not relieved by Advil, lasted until 11/5 around 10 pm temp began to drop, felt a little better. Morning of 11/6 no temp, just a little draggy.  Morning of 11/7 completely normal. Miserable experience - re-thinking shot for next year.
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 52 year old female. 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: 205A21A, expiry: 21-SEP-2021) dose was not reported, administered on 10-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-NOV-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
Patient had tenderness and oozing at injection site the morning after vaccine was given (9/26/13). The patient reported this to the pharmacy on 10-1-13. The area was red and still tender, but not oozing. Pt was instructed to apply NEOSPORIN to area and use cool/warm compresses alternating.
partial dose; A spontaneous report was received from a pharmacist concerning a partial dose Modern's COVID-19 vaccine (mRNA-1273) received.  The patient's medical history was not provided. No relevant concomitant medications were reported.  No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.; Reporter's Comments: This report refers to Product administration error with no associated AEs for mRNA-1273.
11/8 PM patient received vaccine and was doing well 11/9 AM patient woke up with facial urticaria, angioedema, nausea, and chest pressure relieved by albuterol and benadryl 11/12 seen by me for the reaction, well appearing on exam without rash, lungs clear, no chest pain, was on Benadryl q4-6 hours for 3 days at that time 11/15 seen by allergy who instructed the patient to skip second dose of COVID 19 vaccine as they had concern his reaction could have been from the vaccine. On prednisone and albuterol. Referred to cardio for r/o myocarditis.
45 min after the vaccine, she started salivating/mouth was just watering; 1.5 hours after the vaccine, she did actually vomit/pretty violent vomiting episode; Felt like her body was extremely heavy; Limbs feel heavy; She doesn't feel normal; Arm was hurting her quite a bit at the injection site; Hard to lift up her arm without pain. Which was limiting her full range of motion; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Patient has been experiencing some symptoms. She was wondering if it was a part of the vaccine or something else. She also had an episode after getting the vaccine, probably 45 min after the vaccine, she started salivating. She wasn't really nauseated, but her mouth was just watering. She felt like she was going to vomit but didn't vomit in that incidence. Then, 1.5 hours after the vaccine, she did actually vomit. She had a pretty violent vomiting episode. She was now having, not body pains, but it felt like her body was extremely heavy. Her limbs feel heavy. She doesn't feel normal. She was curious if this was a side effect from it. Her arm was hurting her quite a bit at the injection site. It was hard to lift up her arm without pain. Which was limiting her full range of motion. She was kind of wondering if this was common side effects of the vaccine. Or was this something that was brewing. Was something immediately supposed to happen, and to be happening 14 hours after the vaccination. The outcome of the events was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Administered Pfizer 2nd dose. Needed Moderna 2nd dose.  No adverse effects noticed.
Patient called to report swelling, redness, and itching around injection site after about 7 days after receiving vaccine.
Left Arm lymph node swollen. Muscle pain/aches surrounding left armpit and shoulder. Muscle pain/aches lasted approximately 1 week. Left armpit still slightly tender going on 3 weeks.
The day after the 2nd dose I had mild fever (100.1); Body aches that felt like my spine/bones hurt to move.; For several days i also would get random waves of feeling fatigued; Had a mild lingering headache that lasted for several hours.; 9 days after I had lower back pain from doing minimal activity that has now lasted a few days.; 9 days after I had lower back pain from doing minimal activity that has now lasted a few days.; 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: EW0176) via an unspecified route of administration in the arm left on 29Apr2021 at 15:45 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy. Concomitant medications included fexofenadine hydrochloride (ALLEGRA) for allergies from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8738) via an unspecified route of administration in the arm left on 08Apr2021 at 15:45 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. 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 vaccination. On 30Apr2021 at 03:00, day after the second dose the patient had mild fever 100.1(Unspecified units) and body aches that felt like the  spine/bones hurt to move. For several days, the patient also would get random waves of feeling fatigued or had a mild lingering headache that lasted for several hours. Nine days after the patient had lower back pain from doing minimal activity that had now lasted a few days. The patient was still in pain. The patient never had lower back pain before. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events mild fever 100.1(Unspecified units), body aches that felt like my spine/bones hurt to move, random waves of feeling fatigued or had a mild lingering headache and lower back pain from doing minimal activity was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
24MAR93 110PM tc fr mom; reports pt has been crying constantly since vax given this AM; rt leg red, hot, swollen like a ballon had not taken temp; advised PMD or ER attention as soon as poss; rx APAP, ice pack to leg; ordered by ER;
Rash on arms, legs began weekend of 7/24. Itching. After doctor visit and steroid ointment rash started fading. The first week of August, the Rash on legs worsened  with raised bumps that then developed into Petechiae. Then rash spread to cheeks of face. Rash worsens in sunlight. Rash did not go away and worsened. Returned to Doctor 8/5/21 . Given Prednisone and allergy medication. After 3 weeks rash went away. Approximately from July 24 until September 3, 2021 rash was present.  Have avoided sunlight since Treatment.
Low grade fever, diffuse erythematous maculopapular rash, very slight conjuctival erythema.  Duration approx 5 days.
Wrong drug / manufacturer given.  Staff member received first dose of Phizer vaccine. Then was scheduled for Moderna vaccine on 1/31/21 and he received it. After vaccine administration, it was noted that he had received two different vaccines.
I felt fine at 10pm..Within 2 min I was achy and cold.  Went to sleep curled up in a ball. Felt better the next afternoon.
head spinning, nausea, vomiting, blood pressure went up, felt like eyes were going to bulge out
This spontaneous report was received from a health care worker refers to a adult patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 23-NOV-2015, the adult patient received two doses of VAQTA (lot # L004742, expiry date: 18-AUG-2016) (25U/0.5ML) combined as total of 1 ml in a syringe for one adult dose. No adverse effect reported. Additional information has been requested.
About 10 minutes after receiving the Moderna vaccine, my heart rate was elevated.  I spoke to EMS personnel who were working the clinic.  My heart rate was monitored.  Resting, my heart rate was 130 beats per minute for 30 minutes.  After 30 minutes my heart rate began to return to normal.  The next day, while teaching, my heart rate became elevated again.  I had to set down.  After a few minutes, my heart rate began to slow.  For 8 days following the vaccine, I experienced episodes of my heart racing, increased PVCs, and chest discomfort.  I did not seek medical treatment at an ER because symptoms started to subside after 10 minutes.  I also experienced extreme fatigue.
pt recv vax & notes onset of malaise, mild fever, diarrhea 10hr p/each immun;sx were isolated to administration of anthrax vax only;inj site erythema, >5cm or SC nodules or pruritus @ site;exhaustive fatigue/malaise w/in 24hr;
ACTHIB was given with sterile water instead of saline to the 2 month patient, with no AE; Initial information regarding an unsolicited valid non-serious case was received from a physician (Reference number- 00535851) and transmitted to Sanofi on 25-Mar-2021.  This case involves a 2-months-old male patient who received vaccine 0.5 mL dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] (batch number: UJ405AAB and expiry date: 10-Aug-2021) which was given with sterile water instead of saline (product preparation error) on an unknown date for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to (wrong solution used in drug reconstitution) (latency: same day).  Caller would like to know if they need to re-dose  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.