chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse referring to a 17 year and 6 months old (reported as "17.5 year old") adolescent patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 09-MAY-2018, the patient was inadvertently vaccinated with an adult dose of VAQTA lot # N016805 with expiration date 04-SEP-2019,  for prophylaxis (route of administration was not reported). No adverse effects were reported.
Warmth swelling up to waist and down to knee on right side.  Right femur tight/swollen and pruritic.  He was given Benadryl 18.25mg was given orally.
Patient developed anaphylactic reaction after vaccination.  Patient pretreated with 50 mg of benadryl and 3 hours after vaccination had to take 50 mg more of Benadryl due to throat closing up, hives and increased heart rate.    Went to physician assistant and received 50 mg Benadryl and medrol dose pak.  Patient also used albuterol MDI.  Symptoms resolved 6 hours after vaccination.  Continued to have a headache, injection site pain and fatigue for 24 hours.
Pt recvd 1 dose of Engerix-B 20APR92 & the same day exp stinging on inject site; sx resolved 21APR92;
Pfizer Comirnaty monovalent inadvertently given. No side effects reported.
Information has been received from a pharmacist concerning a child who was vaccinated with a dose of Zostavax. The pharmacist did not know why nurse picked up Zostavax and vaccinated the patient. No additional information was available. There was no product quality complaint involved. Additional information has been requested.
Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown. Not Provided          No concomitant medications were reported. No treatment medications were reported Patient had two Moderna vaccines in January. Had COVID-19 in july.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  CC: This spontaneous case concerns a patient of unknown age and gender with no reported medical history, who experienced an unexpected, non-serious AESI COVID-19 after receiving a 2-dose primary series of mRNA-1273 vaccine. Event COVID-19 occurred approximately 6 months after vaccination with the primary series. Further details on the medical history, exact onset of event and vaccination dates, clinical course, diagnostics, and treatments were not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement and the available information.   This case was linked to MOD-2021-620776 (Patient Link).; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no reported medical history, who experienced an unexpected, non-serious AESI COVID-19 after receiving a 2-dose primary series of mRNA-1273 vaccine. Event COVID-19 occurred approximately 6 months after vaccination with the primary series. Further details on the medical history, exact onset of event and vaccination dates, clinical course, diagnostics, and treatments were not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement and the available information.
I fainted 14 hours after the vaccination after I got up in the middle of the night.
8 AM 2/12/21 tingling in L arm and could not move arm. 2/13/21 woke up with sweats and fever 105 F, got ready for work and noticed tachycardia, nausea, fast breathing, Stood up and became dizzy and lost consciousness. Fell and hit back of head. Treated patient with cold pack to head d/t diaphoresis. Took patient to ER at 8:30.
Info has been received from an RN concerning a 2 year old white female with no pre-existing allergies, birth defects or medical conditions who on 6/2/04 was vaccinated SC, with a 1st dose of varicella virus vaccine live (lot 645169/0348N). There was no illness at the time of vaccination. Subsequently, the pt experienced chickenpox. There were no relevant diagnostic tests of lab data. It was also noted that the pt's brother experienced an adverse event. Additional info has been received indicating that no further info is available.
NECK HURTS BY HER SHOULDERS; ARMS BOTHERING; TIREDNESS; HEADACHE; NAUSEA; MUSCLE ACHES; INJECTION SITE PAIN; FEVER; PAIN IN RIGHT ARM; SEVERE NECK SWELLING; This spontaneous report received from a patient concerned a 77 year old female. The patient's height, and weight were not reported. The patient's past medical history included coronavirus infection, and concurrent conditions included tired. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 202A21A expiry: 23-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced severe neck swelling. On APR-2021, the subject experienced pain in right arm. On APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 98.6 F, 99.9 F, 101.5 F. On 07-APR-2021, the subject experienced neck hurts by her shoulders. On 07-APR-2021, the subject experienced arms bothering. On 07-APR-2021, the subject experienced tiredness. On 07-APR-2021, the subject experienced headache. On 07-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced muscle aches. On 07-APR-2021, the subject experienced injection site pain. On 08-APR-2021, Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and injection site pain on APR-2021, had not recovered from tiredness, nausea, muscle aches, fever, arms bothering, and neck hurts by her shoulders, and the outcome of pain in right arm and severe neck swelling was not reported. This report was non-serious.
Fatigue; This is a spontaneous report from a non-contactable pharmacist. A 67-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Apr2021 (at the age of 67-year-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN) and nortriptyline (MANUFACTURER UNKNOWN), all from unknown dates  and for unknown indications. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Mar2021 (at the age of 67-year-old) as a single dose for COVID-19 immunisation. The patient had no known drug allergies (NKDA). 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 an unknown date in Apr2021, the patient experienced fatigue. The adverse event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the event fatigue was recovered on an unknown date in Apr2021.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected.
pt feeling anxious and nervous prior to coming for her vaccine c/o lightheadedness, tunnel vision immediately after vaccination.  pt was place in trendelenburg with significant improvements.  pt sat up with no symptoms.   started eating graham crackers and water. pt dispo home with husband and child and walked outside with no distress.  vitals: T-burg 1749 118/79; rr 18; 77; 118/79; 98% sitting 1753  125/81; rr 18; 71;  100% standing 1803 134/92; 72; 100%
Chills and fever headaches treated with ADVIL and TYLENOL lasting four weeks sweating episodes lasting five weeks extreme exhaustion and weakness unable to perform normal physical activities severe scalps pain treated with VALIUM 5 mg for 10 days  lasting 2 weeks debilitating back and neck spasms and pain lasting 6 plus weeks (see above for VALIUM 5 mg for 10 days) Physical Therapy 2 times a week for massage and TENS therapy and strength exercises prior to vaccine I was extremely fit and painfree..I use to walk (jog) 5-11 miles 4 times a week now only able to walk 2-3 miles with back spasms and discomfort.
Patient suffered unconsciousness, then a brief seizure 10 minutes following her vaccination. Patient was moved to treatment area where paramedics discovered she was bradycardic, hypotensive, and in a junctional cardiac rhythm. Patient was treated with IV fluids, and monitoring and then transported to Hospital of her choosing.
No adverse effect; Expired vaccine used; This spontaneous report was received from a medical assistant regarding to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not reported. The reporter stated that on 23-AUG-2019, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (expired product administered) lot # N029867 and expiry date 06-JUN-2019, (strength, dose, route were not reported) for prophylaxis. The reporter described that rotavirus vaccine, live, oral, pentavalent(ROTATEQ) did not have any temperature excursions prior to administration. No adverse symptoms reported.
Dizzyness, lightheaded, fainting, vomiting, blurred vision, extreme full body pain, extreme cramping, multiple joints locked up causing a temporary but frequent inability to move, reduced range of motion, elevated blood pressure
10-15min p/vax mom states looked in back seat & saw child pale & slumped forward in car seat;unable to arouse pt for 30-45min;pt remained limp, cool, & pale;had resp & pulse;mom took to MD;pt remained w/sx for approx 45min then suddenly ale
Bell's palsy left side of face (eye and mouth). Went to urgent care doc prescribed round of prednisone.  Has improved s little.
Extreme arm pain (9 out of 10 on pain scale), hip pain (7 out of 10 on pain scale), and pain in the joints of the fingers (10 out of a 10 on pain scale)...could not bend fingers and woke her up several times throughout the night
When I woke up in the morning I felt pain in the upper part of my left hand and something like numbness (paralysis) of that part. I still see little bit of redness at the injection spot. Also I was not able to fall asleep last night untill about 11:30 pm which is very unusual for me since I always wake up at 5:30 am and fall asleep at 10:00 pm.
Pt experienced wide spread rash with discrete erythematous macules without pruritus. Rash located head to toe & appearance very similar to measles. BENADYRL & ice given for comfort. Rash onset < 12 hr from immunization & gone within 24 h.
headache; upset stomach presented; experinced sore arm; This case was reported by a consumer via call center representative and described the occurrence of headache in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 16th October 2019).   On 15th December 2019, the patient received the 2nd dose of Shingrix. On 15th December 2019, 12 hrs after receiving Shingrix, the patient experienced headache, upset stomach and pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the headache, upset stomach and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the headache, upset stomach and pain in arm to be related to Shingrix.  Additional details were provided as follows: Six hours after vaccination with dose of Shingrix, the patient experienced sore arm and approximately 12 hours after vaccination, experienced headache and upset stomach. The reporter consented to follow up.
Is still experiencing cough; Is still experiencing fatigue; Started getting symptoms of COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Started getting symptoms of COVID), COUGH (Is still experiencing cough) and FATIGUE (Is still experiencing fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced COVID-19 (Started getting symptoms of COVID). On an unknown date, the patient experienced COUGH (Is still experiencing cough) and FATIGUE (Is still experiencing fatigue). At the time of the report, COVID-19 (Started getting symptoms of COVID), COUGH (Is still experiencing cough) and FATIGUE (Is still experiencing fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, SARS-CoV-2 test positive: positive (Positive) Patient  has been tested negative on 20Feb2021.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment was provided.
Auto immune disease in inner right ear; Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE INNER EAR DISEASE (Auto immune disease in inner right ear) and VERTIGO (Vertigo) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Meniere's disease (In left ear) since 2019. Concomitant products included AZATHIOPRINE (IMURAN [AZATHIOPRINE]) and MYCOPHENOLATE MOFETIL (CELLCEPT [MYCOPHENOLATE MOFETIL]) for Autoimmune inner ear disease, PREDNISONE, METOPROLOL TARTRATE (METOPROLOL XL), ROSUVASTATIN CALCIUM (CRESTOR), FAMOTIDINE (PEPCID [FAMOTIDINE]), LEVOTHYROXINE and DENOSUMAB (PROLIA) for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced AUTOIMMUNE INNER EAR DISEASE (Auto immune disease in inner right ear) (seriousness criterion medically significant) and VERTIGO (Vertigo) (seriousness criterion medically significant). At the time of the report, AUTOIMMUNE INNER EAR DISEASE (Auto immune disease in inner right ear) and VERTIGO (Vertigo) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The treatment with Imuran for autoimmune ear disease was discontinued due to high liver enzymes. The patient received both of vaccinations in left arm shoulder deltoid muscle.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  However patients' past history of Meniere's disease could be a confounding factor in the occurrence of events.   This case was linked to MOD-2021-285741 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  However patients' past history of Meniere's disease could be a confounding factor in the occurrence of events.
Prior to receiving the second dose of Moderna on 4/16/21 my menstrual cycle was very regular, but since the second vaccine my cycle has been coming earlier every month. In May it came 7 days early, in June it came 10 days early.
Information has been received from an office manager concerning a 32 year old male who on 01-DEC-2008 was vaccinated with PNEUMOVAX 23 (lot number 660685/0619X, route and site not reported). After the vaccine was given, the patient developed swollen, red and warm arm. The patient subsequently recovered. This is one of several reports received from the same source. Additional information has been requested.
Nausea; This is a spontaneous report from a non-contactable consumer. A non-pregnant female patient of unspecified age received BNT162b2 (PFIZER-BIONTECH COVID 19 mRNA VACCINE; Lot number: unknown). via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced nausea on 21Mar2021. The patient did not receive treatment for the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of nausea was resolved on unknown date in Mar2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Everything tasting bad, persistent headache, ringing in ears persisting for last 5 months.   ENT follow up  to r/o sinus problems Neuro consult for abnormal MRI notes symptoms possibly related to vaccine and referred to COVID Neuro Specialist,  Medication including muscle relaxers, NSAIDs and Steroids without relief.  Hearing eval with decrease in response at 8-cannot tell if frequency of loss or inability to detect secondary to ringing in ears.
nausea; Chills; Feeling hot; Feeling like she has a hangover; Pediatric formulation of Pfizer-BioNTech COVID-19 Vaccine OMICRON XBB.1.5 was given to an adult patient; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient. Other Case identifier: UNT-2023-030632.  This case is a spontaneous report received on 20 Oct 2023, from a consumer via specialty pharmacy. This 48-year-old, 190-lb female patient began therapy with Orenitram (treprostinil diethanolamine), on 03 Nov 2022 for secondary pulmonary arterial hypertension. The patient was supplied with Orenitram 5 mg and the current dose was reported as 10 mg (2 tablets of 5 mg), oral (PO), three times daily (TID). On 18 Oct 2023, 11 months 16 days after initiating Orenitram, the patient had nausea (nausea), chills (chills), feeling hot (feeling hot) and was feeling like she had a hangover (hangover) after receiving flu vaccine and COVID vaccine. Co-suspect products included: flu (influenza) vaccine and PFIZER COVID-19 vaccine (EUA) (tozinameran). Concomitant medications included: ondansetron hydrochloride [HCL], Adempas (riociguat), lidocaine, fluoxetine HCL, furosemide, Imodium multi symptom relief (loperamide hydrochloride, simeticone), Pepcid (famotidine), tramadol HCL, Synthroid (levothyroxine sodium), Flonase allergy relief (fluticasone propionate), loratadine, gabapentin, lamotrigine, Tums (calcium carbonate), Tylenol (paracetamol), albuterol sulfate hfa, Opsumit (macitentan) and Benadryl (diphenhydramine hydrochloride). Relevant medical history included: secondary pulmonary arterial hypertension. Action taken with Orenitram dose was not reported for the events of nausea, chills, feeling hot and hangover. At the time of reporting, the outcome of the events of nausea, chills, feeling hot and hangover was unknown. The reporter did not provide causality for the events of nausea, chills, feeling hot and hangover with Orenitram. The reporter's causality for the events of nausea, chills, feeling hot and hangover with flu vaccine and PFIZER COVID-19 vaccine was considered to be possibly related.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
24hr p/vax devel circular rash, redness, hardness @ inj site;
Was given Moderna, should have received Pfizer dose 2. Already had Pfizer dose 1
3PM day of injection 10/16/20  patient developed body aches, headache, and soreness at site of injection. 9PM on day of injections patient developed severe rigors for 2 hours. At 3AM on 10/17/20 woke up with 103.5 F fever and delirium. Took 1000mg Tylenol and 800mg Motrin and afebrile at 4AM.  5PM developed rigors again and 101.5 F fever. Responded well to Tylenol and Motrin.
In approximately 12/99, the pt experienced chicken pox with approximately 200 lesions. Subsequently, the pt recovered from chicken pox.
Pruritic rash that started on face and neck, and spread diffusely to torso and extremities. Also developed cough and rhinorrhea on same day that rash started. Rash treated with OTC Benadryl. Rash mostly resolved by 11/18/21.
Developed progressive urticaria within 2 hours after immunization. He returned to the doctors office and was given oral diphenly-dramine and gradually the symptoms abated. He returned home, fully recovered.
patients has stated that dizziness has started approx 1 hours after receiving the short and had had low level dizziness ever since. Never really went away.
intense gastric pain; nausea; back pain; felt lightheaded; A spontaneous report was received from a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced intense stomach pain, intense gastric pain, nausea, back pain, and felt lightheaded.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, thirty-nine hours post injection, the patient stated that she experienced about one hour of intense stomach pain, intense gastric pain, nausea, back pain, and felt lightheaded. She mentioned after the hour she felt fine. No treatment information was provided.   Action taken with mRNA-1273 in response to the events is not applicable.  The outcome of the events, intense stomach pain, intense gastric pain, nausea, back pain, and felt light headed, were resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.