chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 26-Feb-2019 regarding an unsolicited valid non-serious case received from a physician. This case involves a 75 years old male patient who experienced pain at injection site, loss of mobility and burning sensation was radiating down to her left hand, while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy received. On 06-Nov-2018, the patient received a 0.5 ml single dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ043AB via unknown route in unknown administration site. On 06-Nov-2018, The patient developed a non-serious pain at injection site (vaccination site pain) <<immediately following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On an unknown date, The patient developed a non-serious loss of mobility (mobility decreased)following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On an unknown date, The patient developed a non-serious burning sensation was radiating down to her left hand (burning sensation) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. No  lab test reported. Final diagnosis was burning sensation was radiating down to her left hand, loss of mobility and pain at injection site. The patient was treated with MELOXICAM (MELOXICAM) and PARACETAMOL (TYLENOL [PARACETAMOL]). The patient outcome is reported as Not Recovered / Not Resolved on an unknown date for pain at injection site, as Unknown for loss of mobility and as Unknown for burning sensation was radiating down to her left hand.
Fever; Chills; This is a spontaneous report from a contactable consumer (patient). This is a cloned case, report 2 of 2. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 21Apr2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 21Apr2021, the patient experienced fever and chills. Therapeutic measures were taken as a result of fever and chills. The patient stated that they all had certain symptoms but most people have had what they have. The outcome of events was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
When our facility received the Covid - 19 vaccine, I spoke to and was told that the exp. date for the vaccine was 9 months from the. date on the box. Which made the exp. date 5/31/22. On 5/20/22  Contacted me stating that we have given exp. vaccines to patients and that the exp. date was 10 weeks from the date the vaccine was received which would have been 5/2/22. Thus we unknowingly gave exp vaccine to patient.   Patient tolerated vaccine well, no adverse effects have been reported.
Received vaccination day prior to symptoms then developed blisters and redness and swelling on right hand and right elbow and right leg. The vaccine location of MMR was also red and swollen. This looks consistent with a mild Stephens-Johnson.
Patient received FLUCELVAX flu shot per vaccine protocol around 5:00 pm. Patient seemed relaxed and alert while giving shot. About 15 minutes after patient received shot, she became very sweaty and started feeling faint. The patient did not faint. She stated her tank top was soaked through with sweat though. She sat down inside our facility. I brought her a glass of water and some candy. She started feeling better and felt "close to normal" after about 15 minutes. Pt. stayed seated for about an additional 20 minutes.
After receiving the Moderna vaccine on 2/10/2021, traditionally expected symptoms developed on 2/11/2021 and 2/12/2021 including fatigue, fever, headache, and general achiness. On 2/12/2021 and into the morning of 2/13/2021 I developed a persistent aching chest pain - Saturday morning (2/13/2021) I went to convenient urgent care in for a quick once-over including vitals and an EKG. The EKG showed ST elevations, and I was taken via ambulance to the hospital emergency room. With blood lab value analysis and an echocardiogram performed, the hospitalist and cardiologist determined the diagnosis to be peri myocarditis. I was admitted to the hospital for 24 hours of observation and was released on 2/14/2021.
Case number PHEH2015US024663 is a spontaneous report initially received from a pharmacist on 20 Nov 2015. This report refers to a 61 year old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1514801, expiry date: May 2016) intramuscularly at a dose of 0.5 ml on 19 Nov 2015. It was reported that the vaccine administered was exposed to temperatures up to 28 degree Fahrenheit for up to 8 hours. The case was reported as non-serious. No adverse events were reported following the inadvertent administration. Follow up information received from a pharmacist on 20 Nov 2015: Expiry date of vaccine updated.
I received the Moderna COVID-19 Vaccine EUA yesterday. Within the 15 minute waiting period, I didn't have any immediate effects but it did affect me later that night. It first started off with a headache, chills, and a slight fever. Periodically throughout the night, I kept waking up to severe heat flashes, chills, and a fast heartbeat. Regardless of what I did, I couldn't seem to control my heartbeat.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies were reported. On unknown dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot # L021211, expiration date 10-JUN-2017; Lot026408, expiration date 15-JUL-2017; L016127, expiration date 06-MAY-2017; L019124, expiration date 27-MAY-2017)(strength, dose and route of administration were not provided). The doses were exposed to temperatures outside of the recommended range (warmer temperature) before the vaccination. No adverse experience was reported. Additional information has been requested.
Knot under arm; Could not lift arm up after first vaccine; it hurt to lift her arm; This is a spontaneous report received from a contactable consumer for female patient (reporter's daughter) that. A 15-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported.  Caller states after her first shot, her daughter had a knot under her arm, and it hurt to lift her arm and a week after the vaccine on an unspecified date. The event outcome was unknown.  The lot number for the vaccine, [Pfizer-BioNTech Covid-19 Vaccine], was not provided and will be requested during follow up.
Fever, severe local pain extending upwards into left neck and down left arm into wrist and hand, hand numbness, nausea & vomiting - Not resolved yet (6/12/2015).
This spontaneous case from the regulatory authority was received on 22-Nov-2021 from other non-healthcare professional (consumer) via  (reference number: SEQW21-05566) and concerned a 68-year-old, male patient.  The patient's medical history included rheumatoid arthritis. The patient's concomitant medications included sulfasalazine, metoprolol (metoprolol tartrate) and statin, all for unreported indication.    On 18-Oct-2021, the patient was vaccinated with Fluad Quadrivalent (inactivated influenza virus surface antigen (subunit), egg-derived, MF59; dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) for influenza prophylaxis. The batch number reported was 324423, expiry date 30-Jun-2022.  On 18-Oct-2021, an unknown amount of time after vaccination with Fluad Quadrivalent, the patient experienced extreme nausea, headache, explosive diarrhea, weakness and dry cough. The patient was also sleeping for three days straight. The patient wanted to know if the Fluad Quadrivalent was an MRNA vaccine. The patient stated that this was not the first time he was administered vaccines for 65 years of age and older, but this was first time that he experienced these symptoms.  The outcome of the events was unknown.  The reported did not provide causality assessment.  The case was assessed as non-serious.  Company comment: A 68-year-old, male patient was vaccinated with the suspect product Fluad Quadrivalent. On the same day after vaccination the patient developed extreme nausea, headache, explosive diarrhoea, weakness and dry cough. The patient additionally reported hypersomnia. No alternative aetiology was provided. Based on plausible time relationship, causality is assessed as possibly related.; Sender's Comments: A 68-year-old, male patient was vaccinated with the suspect product Fluad Quadrivalent. On the same day after vaccination the patient developed extreme nausea, headache, explosive diarrhoea, weakness and dry cough. The patient additionally reported hypersomnia. No alternative aetiology was provided. Based on plausible time relationship, causality is assessed as possibly related.
Severe toothache on bottom left that occurred one week after each vaccination. After the first injection, tooth ache lasted 4-5 days after onset. After the second injection, tooth ache still occurring three days upon onset.
Information has been received from a physician and the physician's secretary concerning a 14 year old female patient with no known drug allergies, pertinent medical history or concurrent conditions who on 21-JUL-2009 was vaccinated with the first dose of GARDASIL (Lot # 658271/0558X). The patient did not have any reaction after the first vaccination. On 21-SEP-2009 the patient was vaccinated with the second dose of GARDASIL (lot # 658271/0558X). There was no concomitant therapy and no other vaccines were given on those days. 24 hours after the second vaccination (22-SEP-2009) the patient had a seizure. The patient's mother contact an " Emergency Medical Tech" who informed her it was from the GARDASIL but the patient was not taken to the hospital. The patient was last seen in the office 23-SEP-2009. At the time of the report, the patient's seizure was recovering. The physician had ordered an EEG and recommended the patient to be seen by a pediatric neurologist (name not recorded). Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.  10/6/09 PCP medical records, consultations, service date 9/23/09. Assessment: First time seizure. Patient presents with hx of right arm jerking, fell to floor, body shaking, turned grey/blue, biting tongue, vomiting. Tongue edematous. Followed by another shaking episode. Does not remember episodes. Patient remains confused.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021 at 1:43 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 2:05 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 47.27 at vaccination on 02-Mar-2021 and 47.35 at 30-Mar-2021.  On 02-Mar-2021, excursion time were 09 AM, 10 AM, 11 AM, 12 PM, 02 PM and 03 PM, temperature was 27, 29, 32, 33, 35 and 36 respectively, total doses given for the day was 177, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 02-Mar-2021. 16 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021.  On 30-Mar-2021, excursion time was 09 AM, temperature was 33, total doses given for the day was 173, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 30-Mar-2021. 3 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021.    The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Concomitant medication was not reported. Treatment medication was not reported.
mom presented @ clinic 24hrs p/vax;states pt was fine until 30mins ago @ which time began crying & broke out in rash;afeb;lacey, fine, red, macular rash on legs (below knees only);no swelling or rash @ vax site;high pitched cont crying
Dizziness, Headache, Myalgia,  fatigue, decreased appetite, later felt like tonsils swollen, hard to swallow Narrative:  reported fatigue, dizziness, ha, cold sweats and decreased appetite,  and nausea, and winded with activity within 24 hours of injection. approx 27  hours post injection felt like tonsils were swollen, hard to swallow. was able to  breath without problem. prompted ER visit, observation, NSAIDs released 4  hours later.
Information has been received from a consumer concerning her daughter, a 15 year old female who on 04-APR-2009 was vaccinated with the first dose of GARDASIL. The mother's patient stated that her daughter was suppose to receive the second dose of GARDASIL on 06-JUN-2009, because she had an ear infection. The outcome of the event was unknown. The patient sought unspecified medical attention. No further information is available.
Splitting headache, sinus pressure, 102.3 degree fever, body aches, chills, sore throat, runny nose, sore arm, fatigue. Took Advil at 7:00 PM on 2/14/21 because I couldn?t tolerate the pain anymore. It is 11:30 AM on 2/15/21 and still fatigued, aches, chills, and headache.
I received the first dose of Moderna Covid vaccine on 4/14/2021, the second dose on 5/14/2021.  I felt the usual chills and tiredness after the second dose, fine by the next day.   At some time in the summer of 2021, after the second dose of Moderna, however, I started developing alopecia and joint pain (particularly in forearms and hands).  I am a very healthy, athletic 41 year old that does martial arts regularly.  I had never had alopecia (and didn't know what it was), or joint pain previously.  I went to the dermatologist for the alopecia, and was prescribed topical cream. It seems like the joint pain and alopecia are slowly resolving by fall 2021, but I wanted to mention it.  I am still experiencing these to to an extent.  The alopecia is located at the back of my neck, near my collar line.  The joint pain is focused in my hands and forearms but felt throughout.
On 3/18/01 the pt experienced decreased appetite, on 3/19/01 an elevated temp of 101 - 103, on 3/24/01 saw the pediatrician. Had a few white patches on tonsils. Pediatrician felt the symptoms were a reaction to MMR vaccine.
New onset type 1 diabetes within 3 weeks of vaccination.  Notably, pt does have a 1st degree family history of type 1 diabetes.
1 day after vaccine pt had headaches, fever, muscle pain, nausea, abd pain, lethargy.
Blood in urine. There has been no pain or stinging. There has been no urgent need to go pee. This also occurred during my second Pfizer dose. I have also never had these symptoms before apart from my two vaccine and booster vaccine.
approximately a week after vaccine, small raised area on arm at injection site. very slightly red color, feels like a hard lump/knot in muscle. tender to touch but not painful. mildly itchy (enough to notice, not unbearable or overwhelming)
55 year old male, vaccinated with J&J on 6/22/2021 who tested positive for COVID-19 on 9/1 ultimately requiring intubation on 9/17 and VV ECMO cannulation on 9/24, CVICU course complicated by: 1. Hemorrhagic shock 2/2 GIB (rectal ulcers) s/p colonoscopy and clipping -- > hemodynamically stable, low dose pressors, stable  2. Delirium 3. Bradycardia 4. Klebsiella pneumonia  PLAN: NEURO: Sedation - paralytics off 9/27 - limited dex (caution with bradycardia), continue propofol, continue versed, dilaudid gtts -> weaning as tolerated  - Gabapentin q8 -> increased to 600mg TID on 10/2, seroquel 100mg qhs. Added seroquel 50mg PO BID to try to wean other drips on 10/2. - monitor prolonged Qtc when adding oral agents -> QTc on EKG from 10/3 was 451  - Of note, does overbreathe the vent, gags and coughs, but not following commands and not moving extremities so if he does not wake up with aggressive weaning of sedation today, may need to consider head CT in the next 24-48H.   CARDIAC: Normal biventricular function Afib - resolved on 9/22 Baseline bradycardia - DC amio given bradycardia noted 9/27-9/29 - Minimize dex gtt - repeat TTE 9/27 relatively stable, normal EF, mildly dilated RV with normal RV function  - on and off neo/vaso as needed for MAP goal > 65mmHg  PULM:  COVID PNA s/p VV ECMO cannulation. S/p toci on 9/8, remdesivir (9/6-9/10) - CXR daily - Continue low tidal volume ventilation for plateau < 25 and minimize FiO2  - s/p solumedrol taper to 9/23-9/27. - consult ENT for trach once off isolation  ECMO: - Keep flows > 4L/min to maintain oxygen saturations >80% (assuming SVO2 > 55%, based on desired goal: DO2/VO2 > 3). - Started bival 9/28, goal PTT 40 to 60, at goal   FEN/GI:  GIB 2/2 rectal ulcerations. S/p emergent EGD/colonoscopy (9/26): no evidence of upper GI source; 2 rectal ulcers found w/ pulsating arterial lesions; hemostasis obtained w/ 5x clips, cautery, and epi injection. - TF on 9/28, no active bleeding since GI clipping 9/26 - No rectal tube given rectal clips  - Per GI conversation 9/30, ok to give rectal enema if absolutely needed, but would try suppository first - Goal is BM daily  - GI ppx with PPI - Continue bowel regimen, last BM: 10/2 with stool. Given high OGT output on 10/3 and no BM yet on 10/3, restarted reglan 5mg IV Q6H x 8 doses and also gave 1 dose of lactulose as well.
Reaction started 09/07/19Doctor visit diagnosed Bells Palsy, right side of face. Prescribed Prednisone and antiviral
ON 12/24/20 AT 7PM, DEVELOPED ACHINESS, WEAKNESS, FEVER OF 102 AND VOMITED AND REPORTS FATIGUE. LAST 3-4 DAYS BEFORE RESOLVING.
Armpit swelling, rash on arm and underarm, fever over 103 for 2 days.
10 to 15 min after receipt of vaccines, mother noticed pt's face red and swollen, mother called health dept @ 12:02, advised to take child to ER.  Seen @ local ER treated with Benadryl, facial swelling decreased, discharged to home with order for Benadryl every 6 hrs.  Child in no distress @ 2:30 PM.
Narrative:  J&J vaccine administered 9/12/21, dx with DVT 10/19/21
started screaming about 2 hrs p/shot given; cried for 1 hr then turned blue & stopped breathing; rushed to hosp where pt cont to have apnea; adm to hosp for 6 days; put on apnea monitor;
I tasted Really  bad the .; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18May2021 12:30 (Lot number: Ew0185) at the age of 33 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, SINGLE, Lot number: Ew0171, Administration date: 27Apr2021, Administration time: 12:00 PM, Arm: right), administration date: 27Apr2021, when the patient was 33 years old, for Covid-19 immunisation.  The following information was reported: TASTE DISORDER (non-serious) with onset 04Jul2021 12:00, outcome "recovered with sequelae", described as "I tasted Really  bad the pepsi/Coca-Cola.". Therapeutic measures were not taken as a result of taste disorder.  Additional Information: It was stated that there was no other vaccine in four weeks. There was no covid prior vaccination. There was no covid test post vaccination. There were no known allergies.  No follow-up attempts are possible. No further information is expected.
Administered booster dose of Moderna (blue top).  Person should have received Moderna  Bivalent booster (blue top).    No adverse event occurred.
dizzy; nauseated; my vision was a bit fuzzy; my ears started ringing very loud; I was twitching and that I wasn't very coherent; color was coming back to my face; Felt tired; a sore arm; muscle spasms; This is a spontaneous case received from a contactable consumer(patient). A 23-year-old female non-pregnant patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 23Mar2021 19:00 as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 23Mar2021, 10-15 minutes after getting the shot she felt very dizzy and nauseated. As she was leaving the pharmacy to go to car her vision was a bit fuzzy. When she sat back down she had to close her eyes because she was so dizzy and her ears started ringing very loud. Her roommate said that she was twitching and that she wasn't very coherent. She went back to get the pharmacist who brought Wal-Dryl and a soda. After sitting and drinking for another 10-15 minutes she felt slightly better and color was coming back to her face. Felt tired and dizzy the rest of the night. Felt fine the next day just a sore arm. She had a few muscle spasms since getting vaccinated. The patient lab tests included sars-cov-2 test negative: negative on 09Feb2021 type: Nasal swab, sars-cov-2 test negative: negative on 15Mar2021 type: Nasal swab. The action taken in response to the events for bnt162b2 was not applicable. Outcome of the events was Recovered on an unspecified date.  Follow-up attempts are needed. Information on the lot/batch number has been requested.
While waiting in the observation area, patient began feeling dizzy and very  diaphoretic. Patient started sweating with C/O of hearing lost. Father at side. EMS refused per patient. Cold gatorade water given. Vital signs obtained BP 90/58, P70, 02 99% room air. After approx. 5 mins, patient started "feeling better." Vital signs BP 110/72, P70, O2 100% room air.  Alert and oriented x3. Patient ambulating from facility with father at side.