chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 2-year-old female patient who received ENGERIX B (batch number ZD5CA, expiry date 15th February 2020). On 7th February 2018, the patient received the 3rd dose of ENGERIX B .5 ml. On 8th February 2018, 1 days after receiving ENGERIX B, the patient experienced rash, vomiting and fever. On 9th February 2018, the outcome of the rash, vomiting and fever were recovered/resolved. The reporter considered the rash, vomiting and fever to almost certainly related to ENGERIX B. Additional details were provided as follows: The healthcare professional called to report that the patient experienced adverse events 24 hours after vaccination. The patient did not require any intervention and the symptoms were resolved 24 hours after starting. The case was received from vaccine inside sales to the Agency.
Since receiving vaccine I have been getting cold sores on average twice a month. More sever than prior to vaccine and up to three sores per event. Using acyclovir 5%. At time of vaccine arm turned warm and red, swelling and became painful this lasted 1 week.
Information has been received from a consumer concerning her daughter, 4 years old at the time of this report, with no past medical history or allergies, who in approximately March 1999, at 18 months of age, was vaccinated with a dose of MMR vaccine live (second generation) (lot #625315/1682E). There was no concomitant medication. One week after vaccination, in approximately March 1999, the patient lost her ability to communicate and has been diagnosed with pervasive developmental disorder and functions at the level of a 2 year old. It was noted that prior to vaccination, the patient was a normal 18 month old with a small vocabulary. The reporter was worried that her daughter's condition may have been the result of receiving the MMR. Unspecified medical attention was sought. Upon internal review, pervasive developmental disorder was determined to be an other important medical event. Additional information has been requested. Follow-up info received from the physician indicated that the pt received her first dose of MMR II on 9/23/98 at another facility. The reporter stated that the pt has pervasive developmental delay believed to have an association with the receipt of this first vaccination. The reporter also indicated that there was no diagnostic evaluation. Additional info has been requested.
shortness of breath; weakness; diffuse chest tightness; confusion; dizziness; cardiac failure; pulmonary failure; A spontaneous report was received from a consumer concerning a 51-year-old, male patient who developed cardiac failure, pulmonary failure/respiratory failure and died.  The patient's medical history included hypertension, obesity, bee allergy and bipolar disorder. Concomitant product use was not provided by the reporter.   Patient received first dose of vaccine prior to two weeks to his death (died on 09 Mar 2021).   A week prior to his vaccination as shortness of breath, weakness, diffuse chest tightness, confusion, and dizziness. These symptoms progressed following his vaccination and he was hospitalzed for two days prior to his death on 09 Mar 2021. Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not applicable.  The patient died on 09 Mar 2021 The cause of death was reported as cardio/pulmonary failure with secondary and tertiary causes of hypertension and obesity. Plans for an autopsy were not provided.  The outcome of the events, cardiac failure and pulmonary failure were fatal.; Reporter's Comments: This is a case of death in a 51-year-old male subject with a medical history of HTN, obesity, bee allergy and bipolar disorder,who died 7 days after receiving first dose of vaccine. Very limited information has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: cardiac failure; pulmonary failure
This case was reported by a nurse via call center representative and described the occurrence of fever in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The healthcare professional (HCP) reported that a few patients had experienced fever, usually within 12 to 14 hours of SHINGRIX administration. The HCP declined to provide any further specifics.
Pt developed swollen lymph node in  underarm  in the axillary area of the right arm.  Lymph node was still present 3 weeks later when getting 2nd dose of  PFizer Covid.  Pt went to see MD.  MD stated common with shots and cleared for 2nd dose .  Swollen lymph appears to be getting smaller
Information has been received from a 73 year old female with tetracycline, iodine and sulfa allergies who was vaccinated with PNEUMOVAX 23 (lot # 665917/1341Y). Concomitant therapy included cholesterol medicine, acid reflux medication and hormone replacement. The patient reported within two hours of receiving her third dose in her left arm on 26JUL2010, (dates of her first and second dose of PNEUMOVAX 23 vaccine are unknown). She experienced pain in her arm. She could hardly lift her arm later that day. The following day her left arm was red, hot, and swollen. She was examined by a dermatologist on 28Jul2010 and was told she has an infection in her arm. She was prescribed KEFLEX and a topical antibiotic. It was reported the patient is recovering. Additional information has been requested.
Rash with blisters noted on 09/20/2005. Mom brought to office 09/26/2005. Confirmed chicken pox by Dr. Symptomatic care given.
Onset on or about 10/23/13: mom report via phone on 10/29/13 that circle of red bumps started around injection site - (R) deltoid. Rash spread, itchy, some welts, over body. Cough on 10/31/13 - 11/1/13. Pt was not evaluated by a medical provider. Mom did not treat with anything.
t102.4, breathing irratically, sobbing sounds, poorly responsive, eyes partly closed;
Pain at injection site, Joint pain. Headache. Fatigue. Dizziness. Fever. Symptoms persisted for 48 hours. Treatment: Extra sleep and ADVIL every 4-6 hours.
An hour after receiving the vaccine patient felt very sleepy and went to bed. Woke up in extreme pain (9/10) and could not walk due to pain/disability in her back. Her healthcare aid administered TYLENOL and patient was able to get up about an hour after dose. Has been on TYLENOL ATC since Monday.  Pain today is 6/10 with NSAID.
24 hrs. after 2nd injection, I had a very severe headache, body aches, skin sensativity, chills, + fever of 100 degrees. This lasted 16 hrs with fatigue for 3 days.
After shot injection my left arm was extremely sore then soon after that my left arm including my armpit and side of left breast and my left arm from armpit to elbow became extremely painful to move as if it was  muscle strain. Any kind of movement is painful some days are mild and other days are severe. I have gone to seek chiropractic treatment with some relief but here I am 6 weeks later and still having same pain. I use topical pain relief gels and take ibuprofen. .. the next day after injection I did become extremely tired for 2 days but some mild to mod headaches but those have since gone away. I still dont know what else to do with the on going arm pain.
Vaccine was injected (possibly too) high on arm-Injection itself was very painful and radiated down to elbow and wrist. Seems like the nurse hit a nerve. Pain in elbow and wrist was temporary. Pain resolved in upper arm with in 3 days, however, today- 7 days later- achey pain in upper arm, elbow and forearm has returned.
This spontaneous report was received from a Physician Assistant via company representative regarding a male patient of unknown age. Pertinent medical history, drug reactions and allergies and concomitant medications were unknown by the reporter. On 14-OCT-2016, the patient was vaccinated with PNEUMOVAX 23. Since an unknown date in October 2016, the patient was unable to move the arm where he received the injection. As of 18-OCT-2016, the outcome of the event was not resolved. Causality was unknown. Additional information has been requested.
CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's past medical history included hysterectomy, and anaphylactic reaction, and concurrent conditions included sulfonamide allergy, non-alcoholic user, and non-smoker, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced confirmed covid-19 infection. On 30-MAR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns an 85-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 16-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250795, expiry date: 30-Apr-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805465 was crossed linked to original cases 201804863 due to same reporter.
Headache, Injection Site Pain, Diarrhea, Headache, Minor Muscle Pain (Legs)
Received 6 mo immunizations on 7/28/09, mother called on 7/29/09 due to temp of 100.9 and red area on right thigh at site of injection.
On 12/6/10, developed fever & headache.  Treated with Advil until 12/9/10; went to PMD; patient vomiting, 12/10/10, vision loss, adm. to E.R.  12/11/10, transferred to PICU.  Expired 12/16/10.
Narrative:  COVID infection following COVID vaccine series 12/22/2020, Pfizer, dose #1 01/12/2021, Pfizer, dose #2 08/18 pt cc: exposure: unknown 08/18 COVID swab, result: detected 08/18 CXR impression: 1. Ill-defined hazy density, right lower lobe and right middle lobe, possibly right upper lobe anterior segment, may be on a mild infectious or inflammatory basis, with possible superimposed atelectasis and/or scarring, 08/19 CRP result: 1.650 08/20 pt admit Medicine cc:near syncope event dx: Covid-19 infection LOS: 8 08/20 DDIMER result: 0.27 08/20 CXR impression: Basilar subsegmental atelectasis or scarring. 08/20 BP 11.5 08/20 ABG results: i-pH 7.42, i-PCO2 31.2, i-PO2 122, --HCO3 20.3 08/22 DDIMER result: <0.22 08/23 DDIMER result: <0.22 08/27 clinically resolved
Patient developed right upper arm pain, edema, and a macular, erythematous rash within several hours after receiving the Menveo vaccine. He also complained of weakness in that arm. The erythema, edema, and pain spread to include, at maximum, the upper arm from deltoid to elbow and laterally from bicep to triceps. He also reported axillary pain with movement of the arm.  This lasted for five days, with the peak occurring at around 48 hours s/p vaccination. There were no systemic symptoms.
I took the vaccine that morning by the night my arm was sore. I felt drowsy so I went to bed around 9-10pm  I woke up to go to the bathroom but my body felt itchy from the inside out. I lightly rub my belly and went back to bed. When I woke up early that morning my stomach was broke out in hives. It stayed that way for a few hrs along with redness. It look like it went down but as the days went by my red marks turned into scar like marks. My belly started to turn real black and peel like as if I was burned from the inside out. I went to a city MD near my home and they couldn?t tell me anything but they gave me a steroid cream called Triamcinolone Acetonide cream 0.1% it didn?t work. I have a bad ugly black scar now on my upper torso.
Headache, Nausea, Vomiting, bilateral shoulder, bil shoulder, neck pain/stiffness
I had a breakthrough case of Covid-19 with an intense cough sore throat and fever.
pt recvd MMR vax 8APR91 & devel a generalized pruritic rash & swollen neck nodes; pt presented to MD office & subsequently recovered;
Felt like million dollar; patient is feeling bad, not feeling good; stomach bothering a little; Nausea; tired; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE AFFECT (Felt like million dollar), MALAISE (patient is feeling bad, not feeling good), ABDOMINAL DISCOMFORT (stomach bothering a little), NAUSEA (Nausea) and FATIGUE (tired) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030C214) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Medical history information reported.). Concomitant products included VITAMINS NOS (DAILY VITAMINS) for an unknown indication.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, 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 INAPPROPRIATE AFFECT (Felt like million dollar), MALAISE (patient is feeling bad, not feeling good), ABDOMINAL DISCOMFORT (stomach bothering a little), NAUSEA (Nausea) and FATIGUE (tired). At the time of the report, INAPPROPRIATE AFFECT (Felt like million dollar), MALAISE (patient is feeling bad, not feeling good), ABDOMINAL DISCOMFORT (stomach bothering a little), NAUSEA (Nausea) and FATIGUE (tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had three Heart pills, a Thyroid medication and an indigestion tablet as Concomitant medication.  Action taken with mRNA-1273 in response to the events was Not Applicable   This case was linked to MOD-2021-208275, MOD-2021-208275 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: No specific follow-up information recorded.
August 30, 2021:  intermittent new numbness of right foot (vaccine administered right thigh) that was consistent for approximately 7 days.  Worse sedentary.  Now (1 month later) intermittent.  Present typically upon waking, better long walks or other non-sedentary activity.  Slowly improving and is not progressing.  No LE edema.  Evening of September 13, 2021, awoke at 1:30 AM with chest 'tightness'--not pain.  No other MI sx--no left arm radiation, chest pain, or radiation to jaw.  (I'm also a physician).  Had nausea, increased heart rate of 85 (typically 70 bpm), and chest discomfort when taking deep inhale.  Went to work to see patients, and presented to Urgent Care after work with chief complaint of chest discomfort.  EKG was normal.  Labs including D-dimer were normal.  Fever of 99.1 so rapid COVID was done:  negative.  PCR reported 2 days later--also negative.    Tried to go for a slow jog on September 16, and chest discomfort / mild pain still present.  Continues to be present on deep inhale.  Resolves with ibuprofen, but then returns.  Is lessening, and has not spiked the way it did with initial presentation on September 13, but still unable to do more than go for brisk walk without chest discomfort.
Rash all over torso, chest and a little on my back. Lasted just 1 full day, took BENADRYL and took an oat bath.
Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Additional Details: Patient said about 5 minutes into the shot that her throat was tingling and soon after that she said that her tongue was swelling up in her throat. I noticed that she had trouble speaking. She took some benadryl and said he was feeling worse and asked me to give her the Epi-Pen and her speaking was getting worse. After the Epi-Pen her speaking got better and I called for emergency personnal.
From the seventh day, fatigue continued. I just felt not well and then I realized that I felt pressure in my chest and heart and a loss of appetite. I barely got around each day. I had to ask neighbors to walk my dog because I didn't have the energy. I was finally able to see my cardiologist on Feb. 27th, I was in A-fib, he prescribed me Eloquis and Flexicide. He ordered an Echo and put me on a 2-week heart monitor. I went back a week later and they started me on another medication and changed the way I was taking Flexicide. I still feel crappy. I went in on March 16th, he looked at my background and Echo results and I had elevated pulmonary pressure and still in A-fib. He started me on Lasix and said he wanted to do a heart catherization. They found only one 80% blockage and put a stent in. My 2-week heart monitoring showed I was in A-fib the entire two weeks. I went back for follow up April 6th, I was still in A-fib and they sent me for an ablation. I went to the doctor for the ablation on April 27th. The ablation was successful but I had a slow recovery. It was the end of August before I started feeling normal again.
Originally presented to the ED with sore throat, pharyngitis (2/3/10)-Discharged and given azithromycin. She returned on 2/5/10 for abdominal pain, nausea and diarrhea. Dx bilateral ovarian cyst. Vaccine administered 2/8/10-pt developed pain, swelling, warmth at site given vacc and cosyn.
1. Extreme soreness at injection site, still slightly sore 2 weeks later 2. Severe, shooting, pains on left side of right knee making it difficult to walk. This pain comes and goes where I can't walk. It's 2 weeks and that spot on my right knee is still tender 3. nauseous 4. Severe headaches for 3 days 5. slight chills and sweats at night 6. Severe back pains for 3 days 7. Overall muscle and joint aches for 2 weeks 8. Sinus congestion and runny nose I took over the counter decongestants, Tylenol, used heating pads and ice packs, I emailed my physician and he said the symptoms should burn out in time
Pt recvd MMR vax on 30SEP91 & 12OCT91 devel a transient fever & a morbilliform rash on head & trunk;
administrations of improperly strored vaccines; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.  On 21-JUL-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant Human albumin (rHa)), lot # T006792, expiration date: 24-AUG-2021, 0.5 milliliter (route of administration and dosing schedule were not provided) for prophylaxis. The administered dose of vaccine was exposed to the following temperature excursions: -13.5 Celsius degrees for 24 minutes, -11.4 Celsius degrees for 27 minutes and -1.8 Celsius degrees for 2 hours and 8 minutes. There was a previous temperature excursion, as recorded by a digital data logger.   This is one of multiple reports received from the same reporter.; Sender's Comments:  US-009507513-2007USA010374: US-009507513-2007USA010361: US-009507513-2007USA010893: US-009507513-2007USA010434: US-009507513-2007USA010252: US-009507513-2007USA010001: US-009507513-2007USA010334: US-009507513-2007USA011962:
patient was administered a dose of Kinrix on 1/Nov/2022, On that date, the patient's age was 5 months.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 5-month-old female patient who received DTPa-IPV (Kinrix) (batch number H99J7, expiry date 26-MAY-2023) for prophylaxis.   On 01-NOV-2022, the patient received Kinrix. On 01-NOV-2022, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: patient was administered a dose of Kinrix on 1/Nov/2022, On that date, the patient's age was 5 months.). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-MAY-2023 The vaccine administration facility was the same as primary reporter The reporter consented to follow up. The patient received Kinrix at 5 months of age, which led to inappropriate age at vaccine administration.
shaking; Major bodyache; fever; chills; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (shaking), PAIN (Major bodyache), PYREXIA (fever) and CHILLS (chills) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) solution for injection for Asthma and Nasal polyps.    Concurrent medical conditions included Essential hypertension, Gastroesophageal reflux disease, Hyperlipidemia, Drug allergy (with Ceftin), Drug allergy (Niaspan extended-Release), Drug allergy (Zocor), Drug allergy (Lamisil), Asthma and Nasal polyps. Concomitant products included OMEPRAZOLE, AZELASTINE;FLUTICASONE, SALBUTAMOL SULFATE (VENTOLIN HFA), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (WIXELA INHUB), MONTELUKAST SODIUM, ATORVASTATIN CALCIUM, AMLODIPINE BESYLATE;BENAZEPRIL, DIAZEPAM, SALBUTAMOL (ALBUTEROL HFA) and HYDROCHLOROTHIAZIDE, IRBESARTAN (IRBESARTAN HYDROCHLOROTHIAZIDE) for an unknown indication.   On 01-Aug-2021, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 300 mg every other week (strength: 150mg/ml). On 18-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Sep-2021, the patient experienced TREMOR (shaking), PAIN (Major bodyache), PYREXIA (fever) and CHILLS (chills). At the time of the report, TREMOR (shaking), PAIN (Major bodyache), PYREXIA (fever) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Aug-2021, Hepatic enzyme: Elevated.         Patient had little bubble form under skin after dupilumab injection and noted some mild pain near injection site . Spoke with pharmacist who advised that it was not recommended to be on an ace and an arb at the same time due to risk of renal issues and hyperkalemia. He stated he'd talk to his physician about that. He also discussed he had some soreness in his leg still. It was not bad and it's not red or otherwise discolored but wanted to know if that was common.   On 15-Sep2021, the patient had chest cold characterized by chest congestion, tightness, cough, white phlegm and heaviness.  At the time of the report, event was ongoing as the patient was not feeling well (Malaise) (onset: unknown date in 2021, latency: unknown).   The patient was treated with azithromycin (Zithromax z-pak), methylprednisolone (Medrol) and a nebulizer for Lower respiratory tract infection and not reported for rest.  Outcome was unknown for pain in extremity, hepatic enzyme increased, injection site swelling, injection site pain and not recovered / not resolved for rest.  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