chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bell's palsy; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (Bell's palsy) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     Concurrent medical conditions included Type II diabetes mellitus, Psoriatic arthritis, Hypertension and Thyroid disorder. Concomitant products included VITAMIN D [VITAMIN D NOS], LORATADINE, METFORMIN HYDROCHLORIDE (METFORMIN 1A PHARMA), SECUKINUMAB (COSENTYX), SIMVASTATIN (SIMVASTATIN +PHARMA) and HCTZ for an unknown indication.   On 11-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced FACIAL PARALYSIS (Bell's palsy) (seriousness criterion disability). At the time of the report, FACIAL PARALYSIS (Bell's palsy) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; Sender's Comments: This case concerns a 59-year-old female with a serious unexpected event of Facial paralysis. Event latency 14 days from second dose mRNA-1273. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous case reported by a consumer, describes the occurrence of vertigo in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vertigo. At the time of the report, vertigo outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medications, laboratory details or treatment information reported.
This spontaneous report has been received from a healthcare worker (also reported as clinical manager) refers to a patient of unknown age and gender who on 10-DEC-2014 was vaccinated with a dose of ZOSTAVAX (strength, dose and route not reported, lot # K003597, expiration date: 12-MAR-2015), that had been improperly stored. The temperature during the excursion was unknown, as it was not monitored. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Information has been received from a nurse concerning a 22 year old female patient who on 09-NOV-2009 was vaccinated with the first dose of GARDASIL. Lot number was not available. Subsequently, on an unspecified date the patient's throat started closing after vaccination. The patient sought medical attention by a nurse practitioner. On an unspecified date, the patient had recovered. Follow-up information has been received from a nurse practitioner concerning a female patient with no pertinent medical history who on 09-NOV-2009 was vaccinated intramuscularly left GM with the first dose of GARDASIL (lot # 662518/0087Y). On 09-NOV-2009, the patient experienced throat swelling, sore throat and cough just after vaccination. It was also reported that the patient did not require emergency room or doctor visit. No further information is available.
Very similar, possibly slightly more severe as compared with the second dose reaction.  High fever (102-103F), weakness, confusion, dizziness, full body aches, painful sensitivity to light and touch, nausea, extreme fatigue, brain fog, short term memory loss, difficulty finding the right words for things, struggling with simple tasks/planning/decision-making.  The fever, nausea, and the intensity of the aches and light/touch sensitivities mostly resolved after 5 days, but the other symptoms: weakness, confusion, dizziness, extreme fatigue, brain fog, short term memory loss, difficulty finding the right words for things, struggling with simple tasks/planning/decision-making has been persisting. The cognitive effects have been recently (after 5.5 months) been starting to improve (maybe at about 75% of former), but the physical effects like fatigue, weakness, bouts of brain fog, along with development of tingling in hands/fingers, occasional shooting pains in arms and legs, new type of headaches, heart palpitations, and abnormal bleeding extremes are ongoing.
Local reaction, redness/swelling/pain of injection site. Inj. site warm to touch, grew over a period of a few days. MD prescribed BENADRYL. Total recovery.
Patient was sitting on the floor, complained of abdominal pain and then fell over and hit her head. Parent picked her up and noted her to be floppy and non-responsive. Patient was slightly shaky and sweaty, her eyes were open but glassy eyed. EMS was called. Vitals were normal. Patient did not speak for minutes until EMS arrived. Transported to the ED. Took a few hours to return completely to normal. Syncope vs seizure.
Passed out at around 9:58 AM, woke up feeling extreme weakness, shortness of breath, fever, and covered in sweat.
Severe body aches starting approximately 8 hours after injection and lasting 24 hours.  Mild fever beginning around 10am the day after injection, increasing to a fever of 102.1F around 3pm.  Fever broke several hours later.  Loss of appetite.  All symptoms were resolved within 36 hours.
pt recv vax 7JUL95 & 13JUL97 pt devel chickenpox consisting of 50 lesions;
After the vaccine on Jan 29th, I had a small hard spot on my arm, no pain.  A week and a half day later, the site started to itch and was warm to the touch, also lumpy, a couple of spots were raised and warm, itching a lot.  The area was red and about a 4" circle.  I applied a topical Benedryl gel to relieve the itch. That worked and I continued to do that for the next 24 -30 hours.  It's fine now. But my concern is getting the second dose.  Should I do that? or maybe take it in the other arm?   Please let me know. I am scheduled on Feb 26th at 9 am
TOOK SECOND DOSE OF VIVOTIF ON DAY 2 INSTEAD OF DAY 3/ DID NOT COMPLETE VIVOTIF ONE WEEK BEFORE TRAVEL; This spontaneous case (PVX2019-1242) was received from a consumer on 17-May-2019. It describes a female consumer who "took second dose of Vivotif on day 2 instead of day 3 / did not complete Vivotif one week before travel", while being on oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took first two doses of Vivotif in a row. The two doses were taken on 16-May-2019 and 17-May-2019, respectively. Also, she had a planned trip to an endemic area next week on Saturday.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took second dose of Vivotif on day 2 instead of day 3 / did not complete Vivotif one week before travel" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took second dose of Vivotif on day 2 instead of day 3 / did not complete Vivotif one week before travel" was considered as not applicable.
After vaccines in office pt later experience subJ fevers until 10/28 AM responded well to tylenol. symptoms resolved
Headache TIGHT THROAT/SWOLLEN LYMPH NODES/BILATERAL LEGS & LWR ABD THROBBING/SWOLLEN UNDER ARM & BREAST Narrative:
Patient awoke after going to bed with a debilitating headache, severe lower back pain. She felt lethargic. Symptoms continued for 24 hours.
- Sore arm around the injection area for approximately 4 days after shot. - Very mild body warming and aches app. 12 hours after shot that lasted for 2-3 hours.
As patient was in observation area 10 min after her vaccine given she reported; difficulty breathing, throat closing. Patient became  pale, diaphoretic, and fatigued, HR was 123 and 02 saturation was 93. After observation and assessment from provider on site the patient received EPI Pen x1 received at 15:43 patient escorted to COT, EMS called, legs were elevated. O2 saturation was 93, HR 123 with a repeat of 107 after 5 minutes. Radial pulse was strong, professing distal pulse. lungs sound clear. Ems arrived on the scene and assessed the patient no other treatment was received and patient refused to go to the hospital.
Pt started tonight with hives on the back of his neck. When talking to patient, he states he developed one on his arm that was spreading quickly. Encouraged to take benadryl and seek medical attention.
Pt c/o dull headache 2/10 and flushed feeling 25 mins after receiving 1st dose of the vaccine. He reported that his only med hx is allergy to PCN. He was assessed and monitored by NP, EMT and paramedic. BP - 135/94, 134/95, resp - 12, HR- 74, O2 sat - 97%.
Severe Lymphadenopathy  Supraclavicular lymphnodes  axilla lymph node pain 10/10  radiating to neck and back
The patient started to have trouble with his vision after the Covid vaccine. It became worse after the second Covid vaccine. That lot number was EW0158.
This Non valid spontaneous report was received from a registered nurse and refers to an unspecified number of unspecified patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On dates on or after 21-SEP-2017, the patients were vaccinated with improperly stored dose of LIQUID PEDVAXHIB for prophylaxis, lot number N000238 with expiration date of 25-OCT-2019, lot number N003701 with expiration date of 01-NOV-2019, lot number N008079 with expiration date of 02-DEC-2019, lot number N012920 with expiration date of 07-FEB-2020 (strength, dose, route and frequency were not reported); or with improperly stored dose of RECOMBIVAX HB for prophylaxis, lot number N020613 with expiration date of 05-MAY-2020, lot number N002202 with expiration date of 04-NOV-2019, lot number N011851 with expiration date of 19-DEC-2019; or with improperly stored dose of ROTATEQ orally, for prophylaxis, lot number N000175 with expiration date of 20-SEP-2018, lot number N005618 with expiration date of 04-OCT-2018, lot number N005078 with expiration date of 22-NOV-2018; or with improperly stored dose of VAQTA for prophylaxis, reported lot number M019924 with expiration date of 02-SEP-2018, lot number N008823 with expiration date of 26-MAY-2018. No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of 32 degrees F (degrees Fahrenheit) to 35 degrees F for 40 minutes; No previous temperature excursion was done. The call was because of a "data logger". This is a non-valid case due to lack of patient identifier. Follow up information was received from the registered nurse 30-APR-2018. The nurse stated the temperature excursion was stable and they had two refrigerators that held the related vaccines. The nurse was not able to provide patients' names or initials, or ages, but was able to provide number of patients, gender information, and vaccination dates. This report referred to two male patients vaccinated with improperly stored ROTATEQ (oral; lot number N005078 with expiration date 22-NOV-2018) on 29-SEP-2017. Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received. This is one of several reports received form the same reporter(link reports: 1710USA004069, 1805USA001661, 1805USA004617, 1805USA004618, 1805USA004590, 1805USA004591, 1805USA004592, 1805USA004593, 1805USA004674, 1805USA004675, 1805USA004676, 1805USA004677, 1805USA004678, 1805USA004679, 1805USA004680, 1805USA004681, 1805USA004683, 1805USA004967, 1805USA004968, 1805USA004969, 1805USA004970, 1805USA004971, 1805USA004972, 1805USA004973, 1805USA004974, 1805USA004975, 1805USA004976, 1805USA004977, 1805USA004978, 1805USA004979, 1805USA004980, 1805USA004981, 1805USA004982).
pt recvd vax 28AUG95 & started itching that day & had bumps & rash over arms;legs began itching that noc;arm @ inj site was sore but was not hurting;30AUG95 skin foolicutlitis type lesions; hyperkeratosis
"EXCRUTIATING PAIN" IN THE SPOT WHERE SHE RECEIVED HER FLU SHOT 10/11/2016...
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Received its 30-days Exp date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received its 30-days Exp date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received its 30-days Exp date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received its 30-days Exp date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. Vaccine was in thaw state (2 to 8 degree Celsius) from about 24-Dec-2021. Dose was given at 16-Feb-2022 08:20:45  No treatment medication was reported by reporter.
Pt reporting SOb and palpitations. Her vital signs were normal. she felt better after drinking juice.
COVID AFTER RECEIVING THE JANSSEN COVID-19 VACCINE (COVID-19 TEST POSITIVE); This spontaneous report received from a patient concerned a 27 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A expiry: 14-DEC-2021) dose was not reported, administered on 08-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced covid after receiving the janssen covid-19 vaccine (covid-19 test positive). Laboratory data (dates unspecified) included: COVID-19 rapid POC test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid after receiving the janssen covid-19 vaccine (covid-19 test positive) was not reported. This report was non-serious.
Ringing in ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in ears) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 013LA20) for COVID-19 vaccination.     Concurrent medical conditions included Peanut allergy, Drug allergy (HCTZ), Drug allergy (Lozol), Hypertension since 1999 and Coronary artery disease since 23-May-2013. Concomitant products included ALFUZOSIN, AMLODIPINE, LISINOPRIL, ROSUVASTATIN, MULTIVITAMIN [VITAMINS NOS], VITAMIN B COMPLEX, ASCORBIC ACID (VITAMIN C ACID), VITAMIN D NOS and CALCIUM for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced TINNITUS (Ringing in ears). The patient was treated with NAPROXEN SODIUM (ALEVE) at a dose of 1 dosage form twice a day. At the time of the report, TINNITUS (Ringing in ears) had not resolved.            Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Patient details, Other Relevant History, Vaccine information, Concomitant medications, Event details added.
Vaccine was administered at about 15:00 on 12/9/09. About 15:30 pt experienced wheezing, trouble breathing, chest pain, light headedness, dizziness adn chest pain. Dr was called over to evaluate her. Vitals were as follows: Pulse was a little thready, B/P 132/84. Chest clear to auscultation, temp 98.3. She appeared pale and cold. She was instructed to lay down for 20 min. BP was taken again and is 128/82. Then was instructed to sit for 15 min. Pt still feels dizzy and had two asthma attacks on 12/09/09.
Patient presented to the ED and was subsequently hospitalized for suicidal ideation and hallucinations within 6 weeks of receiving COVID vaccination.
Patient felt very nauseated, became pale, and passed out for a few seconds. Blood pressure was low initially.  Patient was laid down flat, cool compresses applied, juice and crackers given to patient, vitals checked x 2. Patient monitored for 30-40 minutes afterwards.
It was reported that an 18 month old male patient received a Tripedia vaccination administered IM in is right thigh on 09/24/01. On 09/25/01, the patient developed a swollen area at the site of injection the size of a jelly jar lid The area  was red, swollen, hardened and warm. Patient was given 1 tsp Benadryl every 6-8 hours PRN and cool compresses PRN. The patient recovered from this experience.
heart palpitations; severe headaches; This spontaneous case was reported by an other health care professional and describes the occurrence of PALPITATIONS (heart palpitations) and HEADACHE (severe headaches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (heart palpitations) and HEADACHE (severe headaches). At the time of the report, PALPITATIONS (heart palpitations) and HEADACHE (severe headaches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use was unknown. Treatment information was unknown.   Reporter did not allow further contact
I started with a stiff neck and a migraine headache.  I received Tylenol for the migraine.  I went to the ER for the symptoms (Medical Center). They told me that they could not give me anything for the stiff neck.  I was unable to move my neck for several days.  I did try an Icey hot for the stiff neck.  The stiff neck still bothers me today as well. I am worried about blood clots.
Exactly 1 week after  first dose., that morning, I started to itch at the vaccine site. It persisted and got worse throughout the day. That night while showering I saw the large red patch and small welts around the vaccine area. I was worried I had infected the area. Next morning I saw a Covid Arm article and felt reassured that's what it was. Itchiness and redness continued until they faded out  a few days later. No treatment. Just made a real effort not to scratch and irritate the site.
pt recv vax 26JUL95 & 29NOV97 & pt devel more than 50 lesions of pox, some of which itched, but overall, a mild case;
Back pain.; His left arm started hurting; A spontaneous report was received from a consumer concerning a 76-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events his left arm started hurting and back pain. The patient's medical history was not provided. Concomitant medications reported were Aleve for drug use for unknown indication.  On 3 Mar 2021, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: Undisclosed) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 23 Mar 2021, the patient experienced the events his left arm started hurting and on unknown date experienced event back pain.He consented to be followed up by safety  Treatment details included, patient has not received  for his symptom left arm started hurting and He is on Aleve for his back pain  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of events, his left arm started hurting  and back pain was unknown.
Large, red, swollen welt on injection site. Raised skin and pink coloring, circular shape surrounding injection site. Warm to the touch. On and off itching. Does not interfere with mobility, no pain, but seems to be spreading slowly.
This spontaneous report was received from a registered nurse concerning to an unspecified number of patients of unknown age and gender. Information regarding the patients' medical history, concurrent conditions or concomitant therapy was not provided. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (strength, dose, interval and route of administration were not reported) lot number: K008410 with expiration date of: 26-FEB-2016. No adverse events or product quality complaints (PQC) were reported. This is one of several reports from the same reporter. Additional information has been requested.
Mother brought 3 1/2 yr old in clinic for immunizations. A DTAP and Hep A were given that was not needed - Child had already had three in 5/22/08. The immunization card was confused with his sister's at the time of service. No reaction to vaccine noted at time. Called mom on 4/22/10 child doing well.
For the past two weeks, PT has had a problem that does not resolve. Received third Moderna dose (100 micrograms) on 8/26/21 in left arm. The only noticeable side effect was stronger arm pain than after the previous doses, and this went away after about 12 hours.  About two weeks later, on 9/12/21, she awoke with extreme dizziness/vertigo, vomiting, and incapacitating muscle ache in left shoulder and left side of neck. This pain shifted after several days to all of neck. Around 9/15/21, she tried the Epley maneuver for the dizziness, but this made the dizziness worse.  PT spoke to her doctor on the phone on 9/17/21. GP prescribed a prednisone regimen that will end on 9/27/21. She also went in to the doctor's office on 9/20/21. Prednisone has resolved the pain problem. But the dizzy spells remain.    Every night when getting up during the night and every morning when arising is dizzy and unstable enough to need help walking anywhere. The dizziness disappears by noon or early afternoon. After that, she feels just about normal and steady on legs, able to take a 30-minute walk. Yesterday, 9/23/21, she even ran a bit, optimistic that problems were over. On the contrary, the dizziness this morning, 9/24/21, was even worse than before.  Prior to 9/12/21, Pt was a very active person who played tennis, swam, walked, and/or ran for several hours a day. The persistent dizziness over the past 2 weeks has forced her to change her lifestyle significantly.  Questions include: 1) Could this be a delayed reaction to the Moderna 100-microgram 3rd dose?; 2) If so, what might be the best treatment for continued severe dizziness that has been most pronounced in the morning?; and 3) How long might such a reaction last? Thank you very much.