chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I woke up around 12:30 in the morning on the 21st of January with a headache and I took 600mg Advil.  I went back to bed and was restless and still had the same pain, so I took 975mg Tylenol. I continued to feel poorly and pain was increasing, so I used Maxalt x 2 without any relief.  I became nauseated and diaphoretic with increasing pain in my head.  I woke my husband to take me to the ER for relief.  My pain was 8 and all vital signs normal.  1 liter of Saline, Toradol 30mg IV and Zofran got the headache to a 3. I did follow up with my doctor later that day for further eval.  I have not had a headache that bad in 17 years.
swelling; sore arm; This case was reported by a other health professional via sales rep and described the occurrence of swelling in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced swelling and pain in arm. On an unknown date, the outcome of the swelling and pain in arm were recovered/resolved.   It was unknown if the reporter considered the swelling and pain in arm to be related to Bexsero.  Additional details were provided as follows: The reporting medical assistant was patient's mother. The age at vaccination was not reported. The medical assistant mentioned that the patient received Bexsero and experience swelling and had a sore arm for approximately 2 weeks. The reporter did not agree to follow up. This case linked with US2019AMR150098 and US2019AMR150108, reported by same reporter.
Patient experienced an approximately 1 hour episode of chest pain (early morning of 3/24/03 approx 2:00 am).  No other signs or symptoms. Described pain as possibly consistent with severe heartburn, but says he does not often get heartburn.  Patient has no cardiac disease risk factors with the exception of hyperlipidemia.
Patient called to report that last evening (4/2/21) he began to develop hives on the same arm as administration of vaccine as well as on trunk and back. He did not need to use an Epi Pen or go to the emergency room. He asked if he could use antihistamines to relieve itching and swelling of hives and he contacted his PCP who also recommended antihistamine use.
pharmacist who administered the 2nd dose missed deltoid injection site and went too South; 2 inch circle at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (2 inch circle at injection site) and VACCINATION ERROR (pharmacist who administered the 2nd dose missed deltoid injection site and went too South) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A and 048F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION ERROR (pharmacist who administered the 2nd dose missed deltoid injection site and went too South). In October 2021, the patient experienced VACCINATION SITE REACTION (2 inch circle at injection site). On 11-Oct-2021, VACCINATION ERROR (pharmacist who administered the 2nd dose missed deltoid injection site and went too South) had resolved. In October 2021, VACCINATION SITE REACTION (2 inch circle at injection site) had resolved.            Concomitant medication details were not provided. Treatment details were not provided.   This case was linked to MOD-2021-354180 (Patient Link).
Pt developed a 3 x 5 cm circumscribed, annular erythema and swelling.
Pulsatile tinnitus (feeling/hearing heartbeat in right ear), associated with frontal headaches lasting 3-4 hours each morning. Now > 6 weeks later, symptoms still persist every day, but does not endure as long. Instead, now same symptoms occur for a few minutes several times a day, every day.
Approx 7 hours after injection,  started experiencing diarrhea.  Around 14 hours post junction, nausea and fatigue. 24 hour after injection,  vomiting and headache. It is now 72 hours after injection,  still experiencing nausea, vomiting, diarrhea,  fatigue, headache.
MIGRAINE ON OCASSION; Low Energy Level; Cognitive alertness/cannot think as straight; Could not Sleep; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (MIGRAINE ON OCASSION), INSOMNIA (Could not Sleep), ASTHENIA (Low Energy Level) and COGNITIVE DISORDER (Cognitive alertness/cannot think as straight) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Psoriatic arthritis and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concurrent medical conditions included Psoriatic arthritis.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Nov-2021, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg 40 mg. In 2021, the patient experienced INSOMNIA (Could not Sleep). On an unknown date, the patient experienced MIGRAINE (MIGRAINE ON OCASSION), ASTHENIA (Low Energy Level) and COGNITIVE DISORDER (Cognitive alertness/cannot think as straight). The patient was treated with ZOLPIDEM TARTRATE (AMBIEN) for Difficulty sleeping, at an unspecified dose and frequency. In 2021, INSOMNIA (Could not Sleep) had resolved. At the time of the report, MIGRAINE (MIGRAINE ON OCASSION), ASTHENIA (Low Energy Level) and COGNITIVE DISORDER (Cognitive alertness/cannot think as straight) had not resolved.            Concomitant medications were not reported.  It was unknown if patient was enrolled in COVID-19-Vaccine Trial. Patient did not felt humira effective for 14 day, Humira did not work and Cognitive alertness/cannot think as straight with Adalimumab Solution for Injection, Single-Dose Pen.  The reporter's causality for the event(s) of Cognitive alertness/cannot think as straight, Could not Sleep, Low Energy Level and MIGRAINE ON OCASSION with adalimumab Solution for Injection was Not Provided
The patient received his vaccine and 5 minutes later complained of feeling dizzy. He was instructed to sit and before we could help him into a chair he lost consciousness and fell. His fall was somewhat controlled by the technician. I then assessed the patient and determined he had a vasovagal episode and lifted his legs, he returned to consciousness within 10 seconds of raising his legs. I then allowed the patient to lie on the floor for approximately 20 minutes after which he felt better and returned to sitting . He then sat for about 15 more minutes until a family member was able to arrive. The patient reported no other adverse effects other than dizziness, lightheadedness, some trouble hearing and tingling fingers.
She advised her symptoms started on 08/05/2021. She advised she was admitted to the hospital at  08/05/2021. She was released on 08/10/2021. She was diagnosed with Pneumonia. The case advised she is fully vaccinated.
little bit of pain on my underarm; high fever; bad headache.; Vomiting; body ache; Chills; Disorientation; Nausea; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient age received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: ER8733), via an unspecified route of administration, administered in Arm Left on 24Mar2021 (received at the age of 39-years-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient experienced high fever, bad headache, vomiting, body ache, chills, disorientation, nausea, and little bit of pain on underarm on 24Mar2021. The patient stated, "The day after I had the shot, I have very bad headache, fever then high fever, vomit, body aches, chills. It was like disoriented. I have high fever and very bad headache, nausea. It was at night when I took up the shot, at the time they put up the injection the only thing I had was I had little bit of pain on my underarm and in the course of the day, of the night all these symptoms are added.'' The patient described the side effects as really strong. When probed for the outcome of events, she stated, "It is worsening. Some of them are persisting, some of them are the went way. " Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Initial unsolicited report received from consumer (patient herself) on 04-Dec-2017. This case involves 68 year old female patient who was vaccinated with 0.5 ml dose of FLUZONE HD (frequency once, batch number, expiration date, dose was not reported) via intramuscular route in left arm on 02 Nov 2017. Stated had received flu vaccines for several years and never had reaction. The patient's medical history and concomitant medications were not reported. On 03 Nov 2017 (reported as by the next day of vaccination), one day following the vaccination, the patient experienced red, hard, hot to touch, swollen area of her left arm. On an unspecified date, post vaccination, the patient also experienced nausea, tiredness, weakness. It was reported that, on an unspecified date, post vaccination, the patient had nausea and weakness and were so severe that she could not "get out of bed" for next 10 days. Then symptoms became intermittent and she was able to be out of bed for some of the time. On an unspecified date, post vaccination, the patient intermittently has felt nauseous, weak, and sweaty to the degree the hair on back of her head is wet, feels flushed but no fever, and has rosy checks. Lab data and corrective treatment were not reported. The patient was not recovered of events. Stated still has symptoms to today, 04 Dec 2017. List of documents held by sender: none.
This spontaneous report as received from a pharmacist refers to a 61 year old male patient. Pertinent medical history and concomitant medications were not reported. On an unknown date, pharmacist realized that the patient was vaccinated with second dose of ZOSTAVAX lot # L036454 dose 2, .65 ml, subcutaneous for prophylaxis, there was one (dose) already in the system from December 2015 (extra dose administered). No adverse events (no adverse event) noted. The outcome of extra dose administered and no adverse event were unknown. No further information to report. Additional information has been requested.
pt recv vax 9SEP96 & 2-3 days post vax pt exp itching rash & bruising on legs, hips, & buttocks;ER or MD visit required;tx w/pred & atarax;
After my second Phizer shot I had the Myocarditis and Pericarditis side effects it was about
Nurse reporting an expired dose of MENACTRA was inadvertently administeredwith no reported adverse event; Initial information received on 15-Nov-2021 regarding an unsolicited valid non-serious case from a Other Health Care Professional via Non-Healthcare Professional via physician via Medical Information (Reference number- 00858521).  This case involves a 13-year-old female patient who was inadvertently vaccinated with the expired dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (Expired product administered).  The patient past medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP); VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) and COVID-19 VACCINE (COVID-19 VACCINE) for prophylactic vaccination.  On 15-Nov-2021, the patient received a 0.5 ml first dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6785AA and expiry date: 31-Oct-2021, Suspension for injection) (Frequency once) via intramuscular route in the right deltoid for prophylactic vaccination.  It was an actual medication error case due to Expired product administered (latency on same day).  It was reported "Call received from Nurse reporting an expired dose of MENACTRA was inadvertently administered. Caller with question on whether dose needs repeating?".  At 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 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.
Swollen lymph nodes left arm pit; This is a spontaneous report from a contactable consumer reporting for himself. A 64-year-old male consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL8982) on 20Jan2021 at 15:00, in left arm, for COVID-19 immunisation. Medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Allergies to medications, food, or other products: no. Within 2 weeks of vaccination the patient was taking unspecified blood pressure/lipid medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Jan2021 at 01:00 AM the patient experienced swollen lymph nodes left arm pit. The event required a physician office visit. No treatment was received. Since the vaccination the patient had been tested for COVID-19 (nasal swab was negative on 08Feb2021). The event was reported as non-serious and was resolving.
100.8°F fever began 12 hours after receiving dose and persisted for 18 hours.  Fatigue; hip pain throughout these hours.  Mild headache began 24 hours after dose, but lasted only a few hours.  Fever did not subside with 1000mg of acetaminophen taken every 4-5 hours.
This spontaneous report has been received from a licensed practical nurse referring to multiple unspecified patients. On unknown dates the patients were vaccinated with doses of ZOSTAVAX lot # L012476 (expiration date 10-JUL-2016), which were improperly stored at -14.7 C for 1 hour and 30 minutes (incorrect product storage). There was no previous excursion. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
PT INDICATES THE NIGHT AFTER RECEIVING THE FIRST SHOT,  SHE HAD HIVES IN THE BACK, AND THEY KEEP COMING IN HER WHOLE BODY.  THEY ITCH AND FORM A CRUST.
Delayed site reaction (reasonably mild); This spontaneous case was reported by a consumer and describes the occurrence of SKIN REACTION (Delayed site reaction (reasonably mild)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Radical mastectomy.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced SKIN REACTION (Delayed site reaction (reasonably mild)). At the time of the report, SKIN REACTION (Delayed site reaction (reasonably mild)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.  Treatment information was not provided.
04/17/2019- Child had a cat scratch to the Rt side of the forehead that had heavy bleeding and swelling.  Seen in the ER and encouraged to come in and get a DTaP.  Mother follows her own vaccine schedule per Dr.  Child came in and was given Daptacel only to the LVL per mother's request.   04/24/19- Mother calls this morning around 9:30am and states she noticed that he had a rash and was slightly raised and warm to touch to LVL where injection was given apx. the size of a baseball.  Child denies the area being painful.  Denies any respiratory distress or other complications.  Phone call message left with PCP, Dr to update him on local reaction.  Encouraged mother to ice the area for about 20 minutes 3-4 times a day and give a Benadryl orally.
Patient received his immunizations and within 5 minutes had a petechial, sandpapery feeling rash at the base of his neck circumferentially. He continued to cry and gagged several times beginning to vomit. He had normal respirations and no swelling of mouth, tongue or lips. He recieved 12.5 mg diphenhydramine.  He settled down and was able to tolerate water and rested for 45 minutes.  He was sent home with his mother with return precautions.
pt recv vax 5FEB96 & 2hr post vax pt exp h/a & leg pain;BP was 90/50;fever of 102 started 1 day later;an ER or MD visit was required;sx resolved 6FEB96 w/o tx;
Low fever, fatigue, passing headache, passing stomach discomfort, passing ear ache.
Telephone Encounter  On call note 5/29/2021 10:42 AM Message from answering service, returned call to patient:  reports atraumatic bruising over past few days, sent mychart pics Right calf - Right ankle  - Right shin JJ vaccine 5/5  No pain , no shortness of breath, some allergy chest issues  ED Provider Notes   Chief Complaint Patient presents with arm numbness Patient also noted left sided facial numbness.  She states that symptoms seem to be improving but are still present.  36 year old female with history of asthma presenting with arm and leg numbness. Patient reports around 1500 yesterday afternoon she developed numbness in the bottom of her left foot and up the back of her leg, along with the back of her left arm. She also notes numbness up the left side of her neck. No headache, blurred vision, back pain, CP, SOB, abdominal pain, or nausea. No recent falls.
This is an instance of breakthrough COVID-19 disease after which death occurred.   The individual was vaccinated with the Moderna product on 02/11/2021, 03/11/2021, and 11/17/2021. They tested positive for COVID-19 on 02/06/2022. They presented to Emergency Department on 02/06/2022, where they tested positive for COVID-19 and were diagnosed with anemia. They were seen by oncology on 02/15/2022. They died on 02/19/2022. I do not see any indication that they were hospitalized.
fever 102, erythema to anterior aspect of bilat thighs of upper arms, tx w/Ibuprofen, resolved w/in 24hr w/o sequela;
Uncontrollable chills for 4 hours until I fell asleep followed the next day by painful swelling under the left arm.
PT presents with global headache that awoke PT from sleep with sensation of pressure behind eyes bilaterally. denies visual changes. reports receiving JJ vaccine 10am.
This nurse drew up 0.5mL of Pfizer covid vaccine and verified with another nurse. This nurse failed to verbalize the manufacturer when verifying, so the volume of Pfizer vs Janssen was confused.  0.5mL Pfizer vaccine was administered. No adverse reaction seen at the time of administration or in the time since.
lightheadedness, fatigue, headaches, mood changes, shortness of breath, nausea, concentration issues, forgetfulness
Administered on the shoulder, very high, was not painful, but did not feel like it was normal. It hurt at night and continued to hurt for weeks. Certain positions it hurts. Dull pain.
I received the vaccine on April 29, 2022 on May 9, 2022 I had a runny nose and used a home test for COVID-19 and tested positive. I contacted doctor, the place I live in to alert them that I had tested positive. I followed guidelines stayed in for five days and then wore mask for five days if I needed to go out. My symptoms were very mild, runny nose like a Spring allergy, some fatigue the first day and a very slight fever.
12 year-old patient received their first dose of the Pfizer Adult vaccine on November 5, 2021.  Patient was inadvertently given the Pfizer Pediatric 5-11 dose (.2ml) on November 26, 2021, as their second dose.  The parent was informed of the administration error as soon as it was detected.  The patient had no adverse reaction.   Per the CDC guidance on COVID-19 Vaccine Administration Errors, if a person aged 12 -17 yrs is given the 5-11 years formulation as the second dose, the patient is considered fully vaccinated and no additional vaccine should be administered to the patient. In an effort to implement best practices and avoid any vaccine administration error in the future, our practice has taken additional steps to include the following: each Pfizer formulation is stored in distinct containers and in different areas of the refrigerator.  Brightly colored, easily recognizable Pediatric labels are affixed to the syringes containing the pediatric formulation to distinguish them from the Pfizer vaccine for persons 12 years and older.  Providers and support staff are also reminded to always verify the age of the patient and the appropriate vaccine to administer.
12pm felt achy and lightheaded. Developed chills and headache. Pain and headache became severe with no relief from Tylenol. Continued throughout day into evening. Sleep of and on. Unable to walk to bedroom. Dizzy and feeling faint. Husband pushed me, by walker, into bedroom and helped me get ready for bed. Could hardly stand or roll over in bed. This was 11pm. Woke up at 10:30am. No further aching. Headache remaining, but mild. Tight feeling around head. Still dizzy. All symptoms resolved by 10pm. Upper left arm warm to touch with no lump.
Large deep bruise at injection site and redness about 2 inches from site of needle entry.  Small lump where redness appeared and tender to the touch
OFF LABEL USE; VACCINE RECEIVED AT HOME BY 17 YEARS OLD PATIENT; HEADACHE; FEVER; This spontaneous report received from a parent concerned a 17 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 22-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-JUN-2021, the patient experienced off label use. On 22-JUN-2021, the patient experienced vaccine received at home by 17 years old patient. On 22-JUN-2021, the patient experienced headache. On 22-JUN-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 103 F. Treatment medications included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from headache, and fever on 23-JUN-2021, and the outcome of off label use and vaccine received at home by 17 years old patient was not reported. This report was non-serious.
At 7:30 am mother found child with rash (spots with red centers and white edges) on face, entire right arm, few to chest and left arm and ankles. Has large redden area on right elbow mother stated" she thinks it's from a bite".
Loss of smell and taste; Loss of smell and taste; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 21Dec2020 08:30 at single dose, second dose of bnt162b2 via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. Medical history included Sulfa allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included phentermine hydrochloride, topiramate (QSYMIA), rizatriptan benzoate (MAXALT). The patient experienced loss of smell and taste on an unspecified date. No treatment was received for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was unknown.    Information on the lot/batch number has been requested.