chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received concerning a pt who was vaccinated with one dose of varicella vaccine in March 2000. On 06/12/00 the pt was exposed to a child with live varicella. On 06/26/00 the pt developed spots. Unspecified medical attention was sought.
Bell's Palsy - face drooped, couldn't keep eye open, left nostril ran only
Received Flu vaccine on 10/25/12 at 4 pm. Fri. 10/26 some pain at site, by Sat. AM 10/27 entire arm aches, armpit aches, no swollen nodes or knots. Has taken Ibuprofen. No bruising at site, arm feels cooler to touch than other arm.
Headache, local redness, itchy. Induration (warmth, redness, tenderness, swelling) at left arm injection site.
This spontaneous report as received from a pharmacist via a company representative refers to a 23 year old male patient. On 30-SEP-2013, (reported on 31-OCT-2013 as "about one month ago") the patient was vaccinated with PNEUMOVAX 23, 0.5 ml, intramuscular. Lot number, expiry date and anatomical location were not reported. On an unknown date patient experienced redness and soreness at the site of PNEUMOVAX injections. Treatment for the events included aspirin and anti-inflammatory drugs, not further specified. The outcome of redness at the site of PNEUMOVAX injections and soreness at the site of PNEUMOVAX injections was reported as recovered/resolved, date of recovery was unknown. Additional information has been requested.
fatigue; have some weirdness; had trouble sleeping.; vagina is doing "spasms"; urinate I also have a little bit of poop.; This is a spontaneous report from a contactable consumer (patient). This 69-year-old female non pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 16Feb2021 (Batch/Lot Number: EL9767) as dose 1, single for covid-19 immunisation. Our family physician, dermatologist, gynecologist, and vulva specialist have all diagnosed this as lichen planus or a variation thereof. Here is thread with DR. 01Feb2021. Medical history included left leg muscle issues at night and Known allergies: penicillin. COVID prior vaccination. Concomitant medications included Lisinopril taken from 2011 (reported as for 10 Years). No other vaccine in four weeks. Labs of the patient look good. All normal but don't have COVID-19 antibodies for some reason. We'll assume your fatigue is from COVID-19 so give it some time and keep me updated. (No symptoms as of this date). The patient had some weirdness going on and have had trouble sleeping. vagina is doing "spasms" for hours on end, keeping the patient awake at night and driving crazy during the day. It has come and gone over the past 3 weeks but has been here for the past 2 days. The other odd thing is that every time the patient urinate the patient also have a little bit of poop. Like 4 times a day. Adverse events start date was 18Feb2021. Ae resulted in: Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. No COVID tested post vaccination. Ae treatment: 4 physicians 16 medications. Outcome of the events was not recovered.
Patient was given a vaccine that expired 4 Days prior. No known reaction occurred. Awaiting call back from company to advise whether to revaccinate or not.
Seven hours after Moderna Vaccine, I experienced rapid heart rate, High Blood Pressure and itching hives under my chin.  I called 911 and EMTs checked my vitals & recommended I go to ER.  My husband drove me to hospital. But we waited in the car and I did breathing and husband massaged my neck until my BP and pulse were a bit lower.  We went home as I did not want to go into ER.  The next day, BP and pulse still high, so I called Nurse Line who said to take antihistamine & pain med to lower slight fever.  Today, my BP is  down to 95/58 but pulse is a little elevated at 97
Severe Dizziness, Headache and nausea. Went to sleep and could not pick my head up from pillow entire next day till Sunday AM. Only woke up 3 x on Saturday for less than 15 minutes each time to take Aleve.
No additional AE; The physician states that five doses of the VARIVAX that underwent the temperature excursion were administered; This spontaneous report was received from a physician and refers to a 12-year-old patient of an unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an 12-AUG-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml, lot # S026925 was confirmed to be not valid (expiration date, dose, anatomical location and route of administration were not reported) for prophylaxis. Administered dose of vaccine was stored in the temperature of - 9.2 degrees Celsius (C) for 30 minutes and in the temperature of -14 degrees C to -10 degrees C ( -14.3 degrees C) for 30 minutes. There were no previous temperature excursions reported. The improper storage was recorded by digital data logger. There was no additional adverse event reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA011114: US-009507513-2008USA011215: US-009507513-2008USA011552: US-009507513-2008USA011473:
Very sore arm with first COVID-19 Vaccine; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EH9899) via an unspecified route of administration on the left arm on an unspecified date at a single dose for COVID-19 immunization. The patient had no medical history. Family medical history of high blood pressure. There were no concomitant medications. On an unspecified date, the patient experienced very sore arm with first COVID-19 Vaccine. Patient stayed home, didn't go to primary. Her weight was between 130lbs and 140lbs. There were no additional vaccines administered on same date of Pfizer suspect. No relevant tests done. Outcome of the event was unknown.
Information has been received through a pregnancy registry from a 28-year-old female with a history of hepatitis A and no allergies, who in June 2005 was vaccinated subcutaneously with a second dose of Varivax. There was no concomitant medication. On 02-OCT-2005, the patient determined that she was six weeks pregnant and her LMP date was 25-AUG-2005. On 02-OCT-2005, the patient underwent a seroconversion test for Varivax. Results of the test were negative. Unspecified medical attention was sought. At the time of the report the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Patient was in observation area with c/o throat "swelling" and coughing. Taken to EMS Room. Benadryl 50mg PO given at 0552. O2Sat 98% on RA, P:118. Denies difficulty breathing or any other c/o. At 0605 - states she's feeling better. Ice pack to throat. Walks out with husband @ 6:19 - states feeling "normal"
COVID-19 SYMPTOMS; FLU-LIKE SYMPTOMS; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 57-year-old male. The patient's weight was 181 pounds, and height was 71 inches. The patient's past medical history included: covid-19 (SEP-2020), patient had COVID-19 virus test which was positive, and concurrent conditions included: hypertension (well controlled) and drug allergy (allergic to most opioids). The patient previously received covid-19 vaccine ad26. cov2. s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: 23-AUG-2021) dose was not reported, frequency 1 total, administered at right arm on 10-APR-2021 for prophylactic vaccination (dose number in series 1). On 10-APR-2021, in the evening, the patient experienced headache, so he stayed in bed for a few days, felt "flu- like" with general body aches, injection site pain (all events with dose number series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had recovered from headache, flu like symptoms and injection site pain. The patient received booster dose covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, and expiry: 11-APR-2022) dose was not reported, frequency 1 total, administered at right arm on 28-DEC-2021 for prophylactic vaccination (Dose number in series 2). Concomitant medications included influenza vaccine (received on 28-DEC-2021). The patient stated that after receiving vaccine he felt ok until this morning of 29-DEC-2021, and also checked his temperature with oral digital thermometer, which was at 99.8F. The patient stated that he was experiencing the same symptoms (flu like symptoms, headache, slight fever, injection site pain), most notable was the headache (Dose number in series 2). The patient added that he also "got a flu shot" at same time as covid-19 booster and was unsure if the symptoms he was feeling were from that, the covid booster, or if he actually had covid, as he stated that his symptoms "felt just like when he did have covid back in 2020." (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and influenza vaccine was not applicable. The patient had not recovered from flu-like symptoms, injection site pain, and covid-19 symptoms. This report was non-serious. This case, involving the same patient is linked to 20220100850.
She spent a whole day in bed with her second shot; sick after having no problems in a year; Fatigue; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (She spent a whole day in bed with her second shot), ILLNESS (sick after having no problems in a year), FATIGUE (Fatigue) and HEADACHE (Headaches) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced MOBILITY DECREASED (She spent a whole day in bed with her second shot), ILLNESS (sick after having no problems in a year), FATIGUE (Fatigue) and HEADACHE (Headaches). On 04-Feb-2021, MOBILITY DECREASED (She spent a whole day in bed with her second shot), ILLNESS (sick after having no problems in a year), FATIGUE (Fatigue) and HEADACHE (Headaches) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter. No treatment medication reported by reporter.   This case was linked to MOD-2021-378233 (Patient Link).
Minimal blotching upper arms, torso (anter) pruritus. ALLEGRA OTC with f/u appt 10/5/12 expect full recovery with returned to full day 10/5.
3/11/21, 5:00 pm started to feel very cold, fingers started to feel numb, by 6:00 pm had severe chills and shivering, fingers were white and fingernails were blue. I became extremely dizzy, so much so that just moving my head or moving from under my blankets or even talking would create a sensation like zaps or electrical jolts inside my head. By this time, I had about four thick blankets on me. This calmed the chills. If I moved even just my hand outside of the blankets, I would immediately start shivering again. I felt my worst at about 9:00 pm. Slowly got better. Drank a lot of water. Dizziness and chills subsided by about 12 midnight and left me with a headache. Tylenol helped reduce that. Slept the rest of the night. Today from about 9:00 am until currently 5:40 pm, I have had slight muscle aches, fatigue, slept on and off all day. Still a bit dizzy but not too bad.
Lymph node enlargement and tenderness on opposite arm, near elbow (epitrochlear)
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Additional information: patient stated that her friend was prescribed with paxlovid medication that hard to come by. she know that paxlovid can be received if tested positive for covid and its very hard to come by. she had a friend that had to go to multiple stores.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200591001 Same reporter/ drug/ event for different patients.
Mom called. She states that patient had vaccine yesterday. Since then, he has been up wimpering or crying. Did not sleep well last night.  His rectal temp was 103.2. She is giving tylenol, but thinks that he spit up last dose. Patient is eating ok and having appropriate amount of wet diapers. She states that patient had a slight cough prior to getting the vaccinations, but now it's more phlegmy. Please advise.  Nurse Call  Per NP  Continue to monitor. We discussed normal for a slight temp. Lungs were clear on exam yesterday. Continue tylenol or ibuprofen every 6 hours. Should improve in the next 24 hours. If tylenol not working for temp, can try ibuprofen it is ok now that he is 6 months and sometimes works better.
Muscle aches < 24 hrs post vaccine. Difficulty with strength and balance (pulling self up the stairs) day 3 or 4 post vaccine. Seen by MD 11/1/02. Did have muscle soreness in area and neck the night of the vaccine. Still balance/muscle sx. EMG-finding consisted with Guillain Barre-strahl synd. Rec'd IVIG tx. x 5 days. Follow-up information received on 3/4/2003 states that large motor coordination not back to baseline.  Pt's energy level is improving but he still tires at school, especially by the end of the week.  Patient continues to make slow progress eventhough he is not back to his baseline.  Annual follow up on 12/24/03: "Vaccine recipient has recovered from adverse events that was reported for this vaccination."
Bilat Periorbital and facial swelling. However, airway patent. Lungs clear A&P Bilat.
Patient hospitalized for NSTEMI (from 2/18/2021 to 2/20/2021) and discharged on hospice/comfort care. Patient died 2/21/2021.
Information regarding Prevnar was received from a consumer regarding a 2-month-old male patient who experienced a mild fever for a couple of days, was cranky and developed fontanel swelling on the top of his head. The patient recovered from the fever; the swelling and irritability are resolving. See related cases HQWYE560316AUG06 (adverse event, expedited) and HQWYE638117AUG06 (adverse event, non-expedited). No additional information was available at the time of this report.
I am vaccinated (2 Pfizer) and boosted (Moderna). I tested positive and developed minor symptoms; I am vaccinated (2 Pfizer) and boosted (Moderna). I tested positive and developed minor symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Mild asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "I am vaccinated (2 Pfizer) and boosted (Moderna). I tested positive and developed minor symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: tested positive and developed minor symptoms; tested negative; started testing positive and Covid again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient have not taken any other medication in two weeks. Anti viral details: product: COVID 19 Treatment, brand: Paxlovid, treatment start date: 26Apr2022, Treatment stop date: 01May2022. Patient was vaccinated (2 Pfizer) and boosted (Moderna). He tested positive and developed minor symptoms. That night he started paxlovid. He took all 10 doses. During the course he fleet fine and tested negative on rapid tests. A few days after the course he started testing positive and Covid again. He was isolating so it's unlikely that he was reinfected. Symptoms developed.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Pt developed hives after receiving  a DPT, IPV, MMR and Varicella. Medical Assistant immediately contacted RN and Physician. O2 sat, HR and R measured- wnl, lungs clear bilaterally. Bendadryl 2 tsp administered 15 minutes after Benadryl hives 99% gone. Hives first noticed aftert aDPT and varicella. Mom states child was crying and upset prior to injections and feels reaction possibly stress related.
FLUZONE >36 month dose administered to patient, He is <36 month of age. Parent and Supervisor notified.
3RD DOSE MODERNA COVID VACCINE GIVEN 9/10/21, LOT #939902; 4TH DOSE MODERNA COVID VACCINE GIVEN 4/4/22, LOT #042J21A; pt had a positive COVID test on 8/2/22 at Healthcare and Rehab Center 8/4 - 8/6/22 pt had acute hospital stay at Medical Center; transferred from 8/6 - 8/19/22 with secondary to COVID pneumonia, COPD exacerbation with progression to acute respiratory distress syndrome and NSTEMI; pt's condition worsened and he was transferred to Medical Center for comfort measures where he passed away
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. There was no information regarding concomitant medications, medical history or drug reaction/allergies. On unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # K026666 with expiration date 22-OCT-2016, dose and route were not reported). It was reported that the vaccine was improperly stored at 33.6 (unit no provided) for 89.5 hours and then was back in range. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date in August 2014 ("on unspecified dates after 31-JUL-2014") an unspecified number of patients were vaccinated with doses of ZOSTAVAX that were underwent a temperature excursion (stability was supported), subcutaneously for prophylaxis (dosages, and lot# not specified). No adverse experiences reported. The outcome of event was unknown. This is one of several reports from the same source. Additional information has been requested.
Bad Rheumatoid Arthritis flare up; sore arm; chills; fever; fatigue; A spontaneous report was received from a consumer concerning a 71-years-old who received Moderna COVID-19 vaccine (mRNA-1273) and experienced rheumatoid arthritis flare up, sore arm, chills, fever, and fatigue.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included prednisone, tofacitinib citrate, folic acid, sertraline, ropinirole, clonazepam, gabapentin, and nortriptyline.  On 04 Mar 2021, prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number: 027A21A) intramuscularly for prophylaxis of COVID-19 infection.    On 04-Mar-2021, the patient experienced chills, fever, fatigue, sore arm, and a bad rheumatoid arthritis flare up all since 04 Mar 2021. Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event chills, fever, fatigue, sore arm, and a bad rheumatoid arthritis flare up were considered unknown.; 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.
11/24/2021 Began with indigestion, chest discomfort and slight arm pain. then on 11/26/2021 symptoms worsened. Admitted to medical center for cath and stint placement.
Approximately 10 minutes after receiving vaccine the patient's throat felt scratchy, tongue felt itchy, tingling occurred around lips and throat, and eyes felt itchy. Benadryl 25 mg was given immediately after patient complained of symptoms and after 30 minutes of observation patient felt better and left with her husband. Patient followed up with her allergist and allergist recommended her not to get the second dose. Patient reported she wants to get the second dose, therefore, I recommended she take Benadryl before receiving a second dose of the vaccine if she chooses to do so.
This case was reported by a other health professional via call center representative and described the occurrence of fever in a 60-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 12 hrs after receiving SHINGRIX, the patient experienced fever, general body pain, fatigue, rigors and nausea. On an unknown date, the outcome of the fever, general body pain, fatigue, rigors and nausea were recovered/resolved. It was unknown if the reporter considered the fever, general body pain, fatigue, rigors and nausea to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a physician assistant (PA). The patient received a dose of SHINGRIX at the healthcare professional's (HCP) clinic and experienced fever (body temperature: 102.4 degree F) and body ache 12 to 18 hours later. The symptoms had resolved but the HCP was unaware of the timing for resolution. The patient missed one day of work. The suspect vaccine lot number, expiry date and the patient's date of birth were unavailable. This case is 1 of the 3 cases, reported by the same reporter. Lab Comments: On an unknown date, the body temperature was 102.4 degree F.