chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This non-serious medically confirmed report (initial receipt 23-Oct-2014) concerns a 57 year old female patient with no relevant patient history. On the 15-Oct-2014, the patient received the AFLURIA vaccine, (batch number not reported) 0.5 mL via the intramuscular route. A day or so later, the patient experienced pain in the injection site, arm and shoulder blade. Her arm had been very stiff and difficult to move and she stated that it felt like a burning toothache type of pain she lied down on it. The patient self-treated with acetaminophen, cold packs, muscle relaxers all of which had not been working to alleviate the adverse reaction. Outcome was not recovered. Reporter comments: The reporter stated the case to be non-serious.
This case was reported by a physician and described the occurrence of fever in a 4 and one-half month-old male subject who was vaccinated with Pediarix (GlaxoSmithKline) for prophylaxis.  On 30 August 2007 the subject received 3rd dose of Pediarix (.5 ml, unknown).  On 30 August 2007, at an unspecified time after vaccination with Pediarix, the subject experienced fever and inappropriate schedule of drug administration as the subject had received a vaccination at 2 and 4 months of age.  The third dose was inadvertently given at 4 and one-half months of age.  At the time of reporting the outcome of the events was unspecified.
Fever (105) and seizures (over 1 hour back to back) on 11/4/05. Put on ventilator. Admitted to PICU. Off vent on 11/5/05. On 11/6/05 unable to talk, unable to focus visually, not eating. MRI on 11/8/05 showed lesions and swelling of bilateral occipital regions. Transferred to another hospital 11/14/05. Dx ADEM 11/15/05. IV steroids 11/17 for 10 days. Transferred to hospital 11/29/05. I called the mother's number that was on the VAERS sheet.  That number had been chnaged.  I made a note of the new number and called it.  I left a message 24 hrs. ago, I have heard nothing.  I called the child's pediatrician here to see if they had seen the child.  They have not seen her since a couple of days before she received the shot(s) that supposedly caused the reaction.  They gave me a grandmother's number.  I called it and left a message.  I've heard nothing.  The doctor's office did say that an attorney had requested a copy of the child's medical record from them.
Initially numbness / tingling in extremities (hands and feet).  Not persistent - intermittent feelings.  Most severe incident was numbness in right hand for 1.5 days.  Currently feelings are in finger and toe tips.  Ringing in ears has developed.  This ringing is persistent at varying levels.
Rash on my abdomen and arms started about 5 days after the vaccine.  Rash is itchy and looks like raised bug bites.  Itching mostly at night.  Will break out in different areas on arms from day to day. Abdominal rash remains constant.  Started using OTC cortisone to minimize the itch and started taking Zyrtec for the itch. It still remains as of this report and hasn't gotten any better.
Pt received Pneumovax 23 on 11/01/06 came in the office 11/03/06 DX'd cellulitis and fever of right arm s/p Pneumovax. I phoned pt 11/5/06 she said she is doing well. No redness or edema at site now.
Local reaction at injection site, left deltoid. Area red, slightly swollen, warm to touch 31/2 x21/4 circumference of needle site. Area described as itchy and painful. Denies any other S. E.
pt recv vax 5APR96 & w/in 48hr p/vax pt exp jaundice;MD visit was required
Immunization given with another immunization (Hexavalent).    Prevnar 13 should have been given, not Pentacel.  No current adverse reaction.  Mother notified.
After a flu shot, I develope a alergic reaction (skin rash)on my right arm (shot was given on this arm)around my abdomen and my back, also some in my legs.The flu shot was given to me at 10:45 am and the alergic reaction start around 3:00pm when my body start to itch, by 6:00pm I took 2 capsule of Benadryl and also apply Benadryl cream on my skin.After an hour and a half the redness on my skin starting to go away.I will check with my doctor tomorrow.
Patient received the Pfizer booster dose on 6/14/22 at 9:20am.  It wasn't discovered until 3:15pm that the vaccine had expired on 4/10/22.  I have followed up with the patient and he is doing fine.  I have reached out to Pfizer to see if the patient needs to be revaccinated or not.  Awaiting results from Pfizer
The patient was given a dose of Moderna covid 19 vaccine, but he is only 16 years old.
Swollen lymph nodes with all 3 Pfizer shots. Swollen lymph nodes on collar, neck, groin,bone/ Went to urgent care and side swollen lymph nodes were due to vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP), Program ID: The reporter is the patient.  A 49-year-old female patient received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Swollen lymph nodes with all 3 Pfizer shots. Swollen lymph nodes on collar, neck, groin, bone/ Went to urgent care and side swollen lymph nodes were due to vaccine". The events "swollen lymph nodes with all 3 Pfizer shots. swollen lymph nodes on collar, neck, groin, bone/ went to urgent care and side swollen lymph nodes were due to vaccine" required emergency room visit.  Additional Information: It was reported that swollen lymph nodes with all 3 Pfizer shots. Swollen lymph nodes on collar, neck, groin, bone. Went away after a week each time. Went to urgent care and said swollen lymph nodes were due to vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pfizer / BioNTech / Treatment of COVID-19 07Aug2022; Pfizer / BioNTech / Treatment of COVID-19 07Aug2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 02Oct2021 as dose 3 (booster), single (Lot number: ff2589), in left arm and on 11Apr2022 as dose 4 (booster), single (Lot number: fk9894) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "blood pressure" (unspecified if ongoing). Concomitant medication(s) included: DILTIAZEM; LISINOPRIL; ROSUVASTATIN.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Pfizer / BioNTech / Treatment of COVID-19 07Aug2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Tested positive 10 days after testing negative day 5 and day 7; (11Aug2022) Negative, notes: Tested positive 10 days after testing negative day 5 and day 7; (13Aug2022) Negative, notes: Tested positive 10 days after testing negative day 5 and day 7. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid treatment start date was 7Aug2022 and stop date was 11Aug2022.  Clinical Information:Patient received vaccine received and other medication in 2weeks.
pt recvd vax & started to shake ax temp pre immunization was 98.6 ax; Rectal temp p/inj was 105.4PR; pt had prev vax w/o adverse rxn;
21-year-old woman with h/o CNS 1, stage III B cell lymphoblastic lymphoma s/p treatment. She recently completed treatment. She has received the Jansen vaccine in the past. Of note, she had a h/o anaphylaxis to PEG asparaginase. She has been cleared by her allergist to receive the Pfizer vaccine. Today, she presents for her second dose (first Pfizer dose).    Patient tolerated vaccine well. No immediate anaphylactic response. She was monitored on continuous pulse ox for 45-50 minutes. Serial vitals were taken. One instance of tachycardia to 120 associated with anxiety, otherwise completed asymptomatic. No other vital sign abnormalities. At 1122, patient reported mild itching along back. Back carefully examined. A small quarter sized erythema was noted left upper spine. Back, chest, abdomen, legs did not have any notable rashes or concerns. Given known medical history, h/o anaphylaxis, one dose of PO 25 mg Benadryl capsule was administered. Mother and patient did not wish to take 50mg given dose strength, despite weight of 49.9 kg. Patient was monitored for an additional 10-15 minutes. Small area of erythema completely gone/resolved following medication. Body was further examined and no additional erythema, rash, itching was present. Airway was examined again, there was not notable angioedema, tongue/lip/oral cavity swelling.   Patient reports feeling well without any symptoms. No more itching.
During injection, vaccine leaked out of syringe at needle connection site. Another dose was drawn up & administer without incident.
Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patient were vaccinated with improperly stored ROTATEQ (lot # L000425, expiration date 21-JUN-2016, dose was not reported) orally. Concomitant drug was not reported. No adverse effect was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Body collapsed. Bedridden, left arm went up half way-needed a sling arm still the same. arm drops down when put up in air. When walking my body veered off to the side.
Tuesday mom noticed a little lump. Child complained of ouwee. No redbess. Wednesday, babysitter called mom because she had noticed redness on left leg. Mom called health dept, they said if swelling and redness increased to go to ER, told to give Tylenol and cool compresses. Mom came in Thursday morning with child's left leg 3" X 3" redness and 1" X 1" induration. Child playing, eating, walking, is active and alert. Taking Tylenol. No other symptoms. Told that if symptoms increase to see MD.  Child playing, eating, walking. Pt is active and alert. Taking Tylenol, no other symptoms per mom told if symptoms increased to take to doctor.
Swollen red (rash looking, raised ) and sore at injection site. 3-4 inches in diameter. Looks like I have been stung by a bee. I have pictures.
Patient has had muscle fasciculations in the bicep since vaccination.  Noted aproximately a day or two later and have continued over the month.
have Covid disease after 5 Pfizer immunization shots; have Covid disease after 5 Pfizer immunization shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) reporting for her husband.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "have Covid disease after 5 Pfizer immunization shots". The event "have covid disease after 5 pfizer immunization shots" required physician office visit. Physician medical provider prescribed Paxlovid. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300070772 Same reporter /drug/event ,different patient;
Severe chills; Body aches; Fever of 100.7; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6204) via an unspecified route of administration in the left arm on 07Mar2021 at 12:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 14Feb2021 at 12:00(at the age of 36-year-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 15Mar2021 at 01:00, the patient experienced severe chills, body aches and fever of 100.7. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. On 15Mar2021, the patient underwent test of body temperature and tested with a temperature of 100.7(unspecified unit). The clinical outcome of the events severe chills, body aches and fever of 100.7 were resolved on an unspecified date in 2021.   No follow-up attempts are needed. No further information is expected.
patient said a few minutes after getting moderna covid 2nd dose the right side of her head hurt then went away shortly after, checked blood pressure at 12 pm 147/94, patient said usually runs high, bottom number usually in the 80s, said she wanted walk around, stopped back to fill an emergency fill of her blood pressure medication at 12:35pm and said felt okay
Cellulitis (L) arm Tx with Augmentin ES 600/5 mg 2tsp twice a day for 7 days Also Motrin every 6 hr apply cool compress prn will f/u after meds comp
Edema, erythema at injection site has gotten worse in last 2 days, is taking cetirizine, ibuprofen, and topical hydrocortisone.
was mistakenly administered an ipol vaccination today, that had expired on 10oct2022 with no reported adverse event; Initial information was received on 28-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 10 years old male patient who was mistakenly administered an ipv (VERO) [Ipol] vaccination today, that had expired on 10oct2022 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis b vaccine for Prophylactic vaccination.  On 28-Oct-2022, the patient received a dose 2 of suspect ipv (VERO) standard suspension for injection at dose of 0.5 ml once (lot T1E871M, expiry date - 10-Oct-2022) via intramuscular route in the right deltoid for Immunization and was mistakenly administered an ipv (VERO) vaccination today, that had expired on 10oct2022 with no reported adverse event (expired product administered) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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 the 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.
10MAY98 pt devel fever, malaise, nausea, inc swelling @ site;area of heat, swelling, induration approx 8" in diameter surrounding inj site;tx w/pred;
Patient was seen by primary care physician and opthamologist. Patient was diagnosed with shingles (also ocular shingles). Patient reported a rash  from top of head to eye, and from nose to ear  on the right side of the body. He experienced swollen lymph nodes on the right side and eye swelling. He lost half of his vision in the right eye that has still not returned at this time. In addition to the shingles, he experienced an excrutiating mgiraine (10/10 on pain scale) which he described as the worst he has ever experienced. He also expreinced joint pain and fatigue. At this time, he is being treated with a course of valacyclovir.
A physician via a GlaxoSmithKline sales rep. reported the occurrence of inject site pain in a subject who was vaccinated with Hep B vaccine recombinant (Engerix-B). Medical history, concurrent medical conditions, and concomitant medications were not specified. On an unspecified date, the subject received Hep B vaccine recombinant (Engerix-B prefilled tip-lok syringes) and experienced pain, burning, and stinging upon injection. The physician believed the pain, burning and stringing upon injection was due to the prefilled syringes being cold upon injection. Comment: The reporter indicated that there were an unspecified # of subjects who experienced these adverse effects. However, they are not presently identifiable. Additional reports will be generated when identifiers are provided.
Following the vaccine my daughter developed a whole body rash with severe itching that took 4 months to resolve. She was diagnosed with Gianotti Crosti syndrome and there was absolutely no treatment that could help her until it finally resolved on its own.
Developed chest pain, malaise 24-48 hours after vaccine and presented to ER, where he had elevated troponin, echo and EKG changes consistent with acute myopericarditis.
I received the 1st dose of vaccine on 12/16/20 and on that date through 12/18/20, I had severe arm soreness and body aches.  On 12/20/20, I had a sore throat, headache, body aches, and nasal congestion that continued through 12/24/20.  On 12/25/20, I had extreme body aches, fatigue, left arm and leg numbness and tingling, SHOB, temp of 100.6, and back pain.  On 12/27/20, I went to the ER for my symptoms and to be tested for COVID-19, to which I tested positive.  They also tested me for strep and flu, both were negative.  I also developed intermittent and random tachycardia (HR 120-150's), palpitations, chest tightness and chest pain.  I am a RN and monitored my O2 Sats and HR frequently.   My symptoms finally resolved enough for me to return to work on 1/11/21.
Week after patient was all itchy.  By the injection site especially.  place ice packs and over the counter steroid cream for the next four days on and off through out the day.
Rash; arthralgia; lymphadenopathy; malaise - Information has been received from a physician concerning a 46 year old female who on 28 Sep 2000 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation.  Subsequently the patient experienced a face and upper torso rash, malaise, joint pain and lymph node swelling.  unspecified medical attention was sought.  Follow up information indicated that the physician does not believe that be recorded the lot number for the measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation.  information has been received from a physician who reports he is unable to identify the patient .  No further information is available.
Facial swelling. Small bumps at locations of volbella (filler) injections swollen badly
Pt recv vax on 3/24/99; on same day pt exp red/swollen/ warm vax site
Child started wheezing 2-3 hours after shots.  If mother elevates, child wheezing is less and child can go to sleep.
Redness, itching, induration in an approximatly 3in induration presenting 6 days post injection. Pt was seen at day +12.
After getting his flu shot, he is still experiencing a sore arm - he has full freedom of movement - it only hurts at a specific point when he raises his arm - not up high or when relaxed - only on raising at one point.
POSITIVE D DIMER, CHEST PAIN, RIB PAIN ON RIGHT SIDE, DOE, ABDOMINAL PAIN
Parents state that child has severe vomiting for one week after both sets of previous immunizations.  Immunizations were given on 01/18/2007 and a phone call was placed to parents to monitor for vomiting again---no vomiting this time after vaccines received.
Currently pregnant (25 weeks) due June 9, 2021 - no known adverse events in the pregnancy.  Injection site soreness, Vasomotor symptoms, nausea.   Injection site soreness lasted 48 hours. Other symptoms lasted approximately 45 minutes.
no adverse symptoms were reported; Wrong Drug Administered/inadvertently administered VAXELIS; extra dose simultaneously of Hepatitis B; HepB was not deleted from orders and was administered along with Vaxelis; This spontaneous report as received from a nurse practitioner and medical assistant via company representative concerning a 2-month-old patient, gender unspecified with no illness at the time of vaccination. There was no information about the patient's medical history or concurrent conditions.  Concomitant medication include: First dose of : rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and pneumococcal vaccine conj 13v (crm197)(PREVENAR 13),administered on the same date.   Medical assistant reported that the patient was inadvertently vaccinated with a first  dose of diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS), lot number: U7124AA, expiration date: 13-JUL-2024, intramuscularly, in the right deltoid (dose  was not reported)for prophylaxis in combination with a second dose of  hepatitis b vaccine rhbsag (yeast)(ENGERIX), in the left deltoid (lot number: FB9RH, expiration date: 21-JAN-2024) (dose was not reported) for prophylaxis instead of the originally reported Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (dose, route of administration, lot number and expiration date were not reported), on 20-DEC-2021 in separately locations. No additional information provided. No additional adverse events reported. No product quality complaints reported. No further details provided. No digital data logger was reporter.  The medical assistant mentioned that while ordering new vaccines for the well visit , and the Hepatitis B was not deleted from the orders (product prescribing error) and the vaccines were administered along with diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) (wrong product administered, extra dose administered), on 20-DEC-2021. The medical assistant immediately reported to provider after vaccines were administered.  The nurse practitioner reported that poison control and the company was notified: the Toxicologist and the physician with the poison control alone with the company representative reported that hepatitis B to be a very safety vaccine with no expected adverse events, for receiving an extra dose simultaneously. The nurse practitioner spoke with the paternal grandmother and the mom regarding with the information received. It was stated that the patient was that the patient to be sleeping comfortably. No reports of fever or significant changes behaviors reported by the mother and maternal grad mother. The mother was advised to monitor and call if changes in behaviors, redness to injection site and fever would be presented.