chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a licensed practical nurse concerning a 8 week old female who on 10-OCT-2006 was vaccinated with a 2 mL PO dose of rotavirus. There was no concomitant medication. On 10-OCT-2006 the patient vomited the medication and stomach contents.  The baby had just been fed before administration of the vaccine.  Subsequently, the patient recovered.  It was noted that two months later the infant tolerated the next dose of the vaccine.  There was no product quality complaint involved. Additional information has been requested.
Eczema side of mouth; Inflammation size of baseball under right armpit; Inflammation size of baseball under right armpit; This is a spontaneous report from a contactable reporter.   A 49-year-old non pregnant female nurse reported for herself that she received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number and expiry date: UNKNOWN), via an unspecified route of administration at right arm on 27Jan2021 07:00 at hospital as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination the patient did not receive any other vaccines within 4 weeks and did not received any other medications with in two weeks of vaccination. On an unspecified date in Jan2021 patient experienced Eczema side of mouth after first dose of vaccine, Inflammation size of baseball under right armpit, Same arm as vaccine. The patient did not receive any treatment for the events. Patient visited doctor or other healthcare professional office/clinic visit due to events. The outcome of the events Eczema side of mouth and Inflammation size of baseball under right armpit were not recovered.  Follow-up attempts have been completed and no further information is expected.
When I woke up on 3.5.21 i was unable to hear out of my right ear. I went to ENT and had an exam and hearing test and was profoundly deaf in that ear. Left ear is fine.  I have been experiencing loud tinnitus in the right ear, also. The Dr is treating me with a large dose of prednisone for 2+ weeks.  He has ordered an MRI. The hearing after 2 weeks is starting to come back-now I am at 50% hearing.
Swollen lymph nodes under right arm (the injection arm); Headache; Low-grade fever; Fatigue; Muscle aches; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the right arm on 06Apr2021 at 14:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included hypoxia, fatty liver, type 2 diabetes mellitus, spasmodic dysphonia, seborrheic dermatitis, hypertension, sulfonamide allergy, allergy to nuts (Walnut), spice allergy (Cinnamon), topical adhesive allergy (Adhesives). Concomitant medications were not reported. The patient previously took morphine (MANUFACTURER UNKNOWN) from an unknown for an unspecified indication and experienced drug allergy. 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 right arm on 16Mar2021 at 14:30 (at the age of 64-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 06Apr2021 at 22:00, the patient experienced swollen lymph nodes under right arm; the injection arm, headache, low-grade fever, fatigue, muscle aches. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events swollen lymph nodes under right arm; the injection arm, headache, low-grade fever, fatigue, muscle aches recovered on an unspecified date in Apr2021.  No follow-up attempts are needed. No further information is expected.
BOOSTER NOT APPROVED IN PT LESS THAN 16. PT IS ONLY 14 AND HAS ONLY BEEN 175 SINCE 2ND DOSE.
Case number PHEH2012US012688 is an initial spontaneous report received from a medical assistant on 22 Jun 2012: This case refers to 12-years-old male patient. He was received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: X11071), intramuscularly, without being reconstituted with Men A component on 21 Jun 2012. No adverse reaction occurred following this administration error.
Encephalopathy. On 9/14/2010, patient was no longer able to walk forward w/o falling (poor muscle coordination), refused to eat or speak, was unresponsive when name was called or spoken to (looked lost and totally disconnected), started walking backwards, had a fever over 104 degrees, runny nose and cough.
11PM - 6AM  awoke shivvering from head to toe..woozy, head buzzing, couldn't see much except lavender splotches when eyes open;  no strength in arms or legs: collapsed trying to get out of bedroom to bathroom & couldn't get up unassisted; collapsed again trying to get from bathroom back to bed - couldn't scoot or pull/raise myself up with my arms; needed help to sit & rest& collect myself; arms/legs  had no strength at all.... couldn't move unassisted;  took unknown amount of time for husband to help me back to bed....once in bed slept until 6AM..  still weak the following day but vision back to normal - used walker to get around..head still buzzing
Systemic: chest pain and high blood pressure-Mild, Systemic: Hypertension-Mild
Eights days later I insane itching all over my body. The itching stayed for a day or day in a half. Severe muscle pains and fever of 102, headaches. Rash on right side of my body by my rib cage. Diagnosed as shingles.
mom reports unusual crying x 4 hrs p/DTP vax & HIB vax 17DEC92;
Tremors started in upper left arm: Mid to late May,'08. They continue today with body twitches and muscle spasms and painful shoulder muscles and stiff neck. August 23,'08: Blistery, painful rash on arms; looks like shingles. August 24,'08: Rash gone but arms appear Very sunburned and still have stinging/burning sensation. Skin retains red appearance today: Rash and bumps in skin may be present. September 19,'08: Large 'cold sore' appears on upper right lip. September 22,'08: Huge 'cold sore' @ left nostril; in nostril and almost to upper lip. October 14,'08: Small sore on lower lip; inside and outside mouth. October 29,'08: Small sore on tongue. I have not had any 'cold sores', previous to these, since 1992. Historically, I would have a rare small 'sore' on my right upper lip.  11/14/08 Reviewed PCP medical records of 7/11-8/25/2008. FINAL DX: probable motor neuron disease, possible motor neuropathy vs neuronopathy; chronic anxiety, depression; records reveal patient experienced muscle twitches & diffuse fascilulations of UEs & LEs, numbness & tingling, neck pain, anxious, depressed, was under stress & having difficulty sleeping, 10# weight loss.  Exam revealed mild hyperreflexia.  Referred for MRI & neuro consult.  RTC 8/25 w/vesicular rash x 2 days.
Pt given immunization in Left Deltoid.  When he came to our clinic for evaluation two days later, there was redness, swelling, and skin was warm to touch surrounding injection site and extending almost entirely around his upper arm to the elbow.
Covid; Covid; The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received. This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (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 "Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Additional information: reporter's family got Pfizer Covid vaccine primary series and boosters and all four of them still got Covid, but they did not have long term problems with it or didn't get that sick with it. 3 shots of Pfizer Covid-19 vaccine and she had no problem with the vaccine but was wondering if Bivalent and the old vaccine are just the same.  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): PFIZER INC-202201287003 same reporter/event/products, different patient.
Pressure on chest: no treatment, 6 hours Nausea: no treatment, 6 hours Headache: no treatment, 15 hours Insomnia: no treatment, 20 hours
Patient reported that she had a stroke a week after injection.  She has been released from the hospital at this time 11/9/21
Swelling, itching, and pain at the site of vaccination, with a slight bump under the skin. This has continued until today 12/15/2017, although the swelling has reduced significantly. Child experiences itchiness and sometimes pain at the area, which seems to be triggered when child consumes foods such as gluten/dairy (perhaps due to these foods causing inflammatory). Child was developing well, reaching all milestones, and even starting to walk, and consistently said eg. "mama" but suddenly stopped doing these things shortly after the vaccine. Child did not say "mama" again until 18 months, and has since struggled with learning language. Child had unusual difficulty walking and running, and would continually lose balance and fall even several months after learning to walk properly. Child is now starting to display some mild symptoms of autism.
stated that he had a reaction that started 13 days after his second dose of the moderna vaccine.  She states he had fever, chills, headache, and could not get out of bed.  The fever, chills and headache lasted about 4 days.  She states his strength did not return for about a week.
After administration of all vaccines and patient exit, this RN began to document them in the medical record when she noticed the expiration date for the ActHib was 8/11/23, which was 3 days prior. This RN contacted State Health Department  who was made aware of the situation. It was decided to give patient's third dose of ActHib at his 15 month visit. This RN contacted patient's Mother and explained exactly what happened and shared many apologies. She voiced her understanding, stated she was not upset as long as she knows patient is going to be ok, which he is.  No adverse reaction to patient noted at any time and Mom says patient is acting his normal self. She agreed to get third HIB at 15 month visit and thanked this RN for calling and being honest.
reports tinnitus she was experiencing; This is a spontaneous report received from contactable reporter(s) (Pharmacist and Consumer or other non HCP) from medical information team.  A 61-year-old female patient received BNT162b2 (BNT162B2), 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 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "reports tinnitus she was experiencing".  Additional information: Caller would like to know if there are any data reports of tinnitus after receiving a dose of Pfizer covid vaccine. Caller is reporting on behalf of a patient who reports tinnitus she was experiencing. They thought it might correlate to her getting the Pfizer COVID-19 vaccine. Patient had her original series and the first booster. They were asking about if patient should get her second booster.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever, body aches and tiredness started about 14 hrs after receiving the shot. The symptoms lasted approx 24 hours.  Took Tylenol every 5-8 hrs.
Following dose 1, bad flu like symptoms, headache and fatigue for approximately 10 days. Also experienced very itchy skin, but no rash, dizziness and numbness in face/jaw. Following dose 2, on day 2 after injection, have severe flu like symptoms including confusion and extreme dizziness. on day 3 after dose 2, at approximately 7:30 AM, fainted and out cold for approximately 20 minutes. Experienced 4 additional near fainting incidents throughout the day. Episodes continued (near fainting) for approximately one month.
fever and body ache for a day; fever and body ache for a day; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (fever and body ache for a day) and PYREXIA (fever and body ache for a day) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products PANCREATIN (CREON) for Cystic fibrosis and Pancreatic insufficiency and 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) (Intramuscular) 1 dosage form, PANCREATIN (CREON) (Oral) at an unspecified dose and first dose of COVID-19 VACCINE (Intramuscular) 1 dosage form. On an unknown date, received second dose of COVID-19 VACCINE (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (fever and body ache for a day) and PYREXIA (fever and body ache for a day). At the time of the report, MYALGIA (fever and body ache for a day) and PYREXIA (fever and body ache for a day) had resolved.            Concomitant drugs were not reported.  The patient had some side effects with the first dose itself, the second one was pretty ok. The patient had took Moderna booster dose half or full it was not really sure but patient did have mild side effects like fever and body ache for a day. It was manageable. Even if it required another booster patient would go for it.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  Treatment medications were not provided.  This case was identified as part of retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Patient received 0.2ML of the adult pfizer vaccine vial instead of the pediatric vaccine vial. Attempted to contact family on same day of vaccine administration and was unable to.
I think I?m suffering from SIRVA.   The nurse who administered the injection into my arm did it very high, just below the bone (acromion).  I think she injected it into the shoulder capsule instead of the deltoid muscle.   That night I had terrible shoulder pain, could barely lift my arm.  Since then the pain has not gone away and has traveled to the back of my shoulder.  I also have some numbness and tingling.  I?m very worried that this pain may never go away!
On 10/14/2013 above patient received FLUZONE injection at approx 2:00pm. Later on the evening of 10/14/2013 per patient's mother, patient developed facial swelling and myalgias. Facial swelling resolved with BENADRYL administered at home. Myalgias persisting.
Headache, Myalgia, Fever, NauseaVomiting,  chills, soreness at injection site
Nausea, vomiting. Minimal cough. Discomfort in upper chest described as a raw sensation when inhales, indigestion type sensation, sweaty.
I had a missed miscarriage. The type of miscarriage is called a blighted ovum. The baby stopped developing at 6 weeks, 6 days.
Within 24 hours arm at injection site approximately 5 - 6" in diameter, is hard, hot and itchy.  Mother gave daughter Benadryl.  Remained swollen approximately 48 hours.  Did not miss school.  Did not see a doctor.
She received vaccine on 12.28.21.  On 12.30.21 she went to the ER and was subsequently sent to Hospital.  Not sure what the findings were, but she was discharged after several hours.  I spoke with her on the phone on 1.1.21,, She wasn't feeling well.  I asked her what was going on because she had been doing really well for a few months. She stated "Every since I took the vaccine, I have felt really bad."  She died on 1.5.21. Timeline: 12.28.20 Vaccine 12.30.20 ER 1.1.21 Continues to feel bad and reports feeling worse and worse since vaccine. 1.5.21 Died at home.
Heavy breathing, puking, sweating constantly, headache, extreme body aches. Lasted 24 hours
accidentally received an extra dose; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 14-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number XK524, expiry date 8th October 2022) for prophylaxis.   Previously administered products included Boostrix (patient was vaccinated with a full course of BOOSTRIX on an unknown date).   On 6th October 2021, the patient received Boostrix (intramuscular) .5 ml. On 6th October 2021, unknown after receiving Boostrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The reporter was the office manager of the health care professional office. The patient received Boostrix on right arm. The patient was vaccinated with a full course of Boostrix and then accidentally received an extra dose on a different date, which led to extra dose administered. The reporter gave a consent to follow-up with health care professional.
A non-serious, spontaneous report of fever blister on the lip, "felt bad" and runny nose was received from a nurse concerning an adult female, subsequent to FLUMIST. Neither medical history nor concomitant medications have been reported. The patient received FLUMIST vaccine on 31-Oct-2008. Immediately after receiving FLUMIST, the patient began having a runny nose and just "felt bad". Two days later she woke up with a large fever blister on she lip and felt terrible. The following day, she was seen by a doctor, who agreed that her symptoms were caused by FLUMIST. The outcome of the events was not reported.
Patient is experiencing confusion, loss of appetite, and warmness around injection site. I told patient's daughter that injection site reactions are common as well as low grade fever, nauseousness, etc. If it continues/worsens, she should seek medical care.
I received my vaccine on 04/21/2022. On the morning of 05/23/2022 I woke with a dry sore throat, right ear blocked felt like fluid was in my ear. I didn't test positive for Covid until 05/27/2022 at 10pm. I called the doctor the next morning and was prescribed paxlovid. I took the paxlovid for the next five days. symptoms subsided within the 5 days of taking the medication.  Tested negative for Covid on 05/31/2022.
Incorrect # of doses in vial after reconstitution after administration to patient. Pt denies s/s of adverse reaction.
Redness, swelling, headache and intense pain at the injection site. Patient states that she could not move her arm.
Left armpit pain without mass for 4 days, delayed reaction that did not start until 7 days after vaccine. Initial vaccine reaction w mild sore arm on side of vaccine
Patient reports redness and swelling at injection site that was diagnosed as a staph infection by ER provider. Treatment unknown. Called pharmacy on 8-16-21 to report
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 13-SEP-2010, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2015, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Heart rate was 125; Feeling fatigue; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Apr2021 at 15:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and known allergies. 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 COVID-19 vaccine. Concomitant medications included amoxicillin (MANUFACTURER UNKNOWN) and doxycycline (MANUFACTURER UNKNOWN); both for unknown indications from unknown dates and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 22-years-old) as a single dose for COVID-19 immunisation. On 30Apr2021 at 15:15, after injection, the patient's heart rate was 125 (unit unspecified) and blood pressure was 114/68 (unit unspecified). The patient's heart rates were staying between 93 and117 bpm. The patient was also feeling fatigue. The patient was very healthy before second shot. It was reported that no health issues. 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 heart rate was 125 and feeling fatigue was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Pt's wife called 7/10/14 4:28 to notify us that her husband has a warm, puffy redness around the injection site. It does not itch or hurt. He has not treated the area (nor did he inform his wife about it). It started day of immunization. I notified primary care physician for follow-up with pt.