chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She suspects that the batch of Shingrix caused the shingles; pain in the right abdomen; shingles; fever; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number 73T27, expiry date 9th September 2022) for prophylaxis. This case was associated with a product complaint.   On 27th July 2020, the patient received the 1st dose of Shingrix (intramuscular). On 27th July 2020, less than a day after receiving Shingrix, the patient experienced fever. On 6th August 2020, the patient experienced shingles and abdominal pain. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the fever, abdominal pain and pharmaceutical product complaint were unknown.   The reporter considered the shingles to be related to Shingrix. It was unknown if the reporter considered the fever and abdominal pain to be related to Shingrix.  Additional details were provided as follows: The daughter of the patient is the reporter.   The patient received 1st dose of Shingrix at an unspecified pharmacy. The patient reported that 10 days after receiving the Shingrix dose, he developed shingles. The reporter noted her mother received dose 1 of Shingrix, batch number EJ4NB, at the same time as the patient and she had no side effects and the lot number was different than the patient's dose. The suspected that the batch of Shingrix caused the shingles. The reporter was explained that Shingrix is not a live vaccine but the reporter was insistent. There was not product to return and the reporter obtained the lot number from the pharmacy paperwork. The patient also experienced fever and pain in the right abdomen. Emergency room visit required. There was no return or credit. The reporter did not consent to follow up.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-395985 (Patient Link).
Tuesday awoke with sore throat and some sinus drainage.  As day progressed developed headache, congestion, fever, chills, body aches, shortness of breath and brain fog.  By next day I had developed a dry cough, and had an elevated pulse rate (about 130 - 140 resting) and high blood pressure (155/100). Continued to Thursday evening when I took a covid test which came back positive.   Called Friday morning to make telemedicine appt with dr to see if I should seek further treatment.  Dr said rest, should be ok. I called off sick from work and rested.  All symptoms largely resolved except for shortness of breath and cough.  Those have since improved around mid-March but still notice my cardio/breath is not 100%.
A report has been received from a Health Professional concerning a patient, Male subject, who had been receiving FLUMIST QUARDIVALENT (intranasal). FLUMIST QUARDIVALENT started on an unknown date. The patient was administered expired FLUMIST QUARDIVALENT. The outcome of the event of administered expired FLUMIST QUARDIVALENT is unknown. The report was considered to be non-serious.
Flu vaccine #2 was administered to a 7 mo. old on 1/8/16, 6 days later on 1/14/16 patient's dad called Dr. stating patient had a 2-3 min episode of no response with tongue hanging out.  Dr. sent them to the ER to be evaluated.  Per the ER note patient's dad described 2 episodes of not responding with eyes fixed. 1st episode x 5-10 secs; 2nd 3 mins. ER physician spoke with a pediatric neurologist who recommend follow-up the next morning.  Neurology ordered an EEG to rule out seizure activity, which was negative.  Per neurology note due to follow up in February.
Family reports that he came into the house from outdoors c/o chest pain and abdominal pain. 11/30/09 Coroner Report Received. DOD 11/12/09. Cause of Death: Probable Myocardial Infarction, due to seasonal flu, with other significant conditions of Diabetes.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M014908, expiration date 25-MAR-2018 (dose and route of administration were not reported) for prophylaxis. Administered dose of vaccine experienced temperature excursion of 41 degrees Fahrenheit (>14 but <16 degrees Fahrenheit) for 8 hours. Data logger was involved. It was also reported a previous temperature of excursion of 10 degrees Fahrenheit (>5 but <14 degrees Fahrenheit) for 2 hours. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA006257: US-009507513-1702USA010414: US-009507513-1703USA006254: US-009507513-1703USA006255.
On 9/27/00, the pt had a 6 month check up. He was well with resolving BOM. He received DTaP/Hib #3. On 10/28/00 he experienced prolonged sleeping, feverish and vomiting. On 10/29/00, the pt still experienced increased sleeping, developed pulling legs up in pain, vomited 1 time with bile. Physical exam revealed lethargy and mild dehydration. No neuro. Abdomen was normal.  He was also found to hava functional heart murmur. Per F/U 7/2/01: Discharge Dx: mild gastreenteritis also. Dates were 9/27/00-9/30/00 not 10/27/00-10/30/00. Treat with Tylenol 120mg suppository or 1 1/2 dropper of 80mg per dropper infant drops. The pt also had decreased urine output and episodes of crying and 1 loose stool.
Patient had onset of Extreme fatigue 3-4 Days After His second Covid vaccine. Presented to clinic 9/22/21 where new cardiac murmur was noted. Echo subsequently showed severe mitral regurgitation. Cardiologist believes Related to Vaccines.
Patient presented with swelling  and pain of left arm/deltoid. Was treated with Ciprofloxacin 500 mg tablets. Told to follow up if pain or symptoms persist. If worsening, instructed to go to nearest emergency room.
Generalized urticaria & itching onset 6 days p/1st Hepatitis "B" vax; Rx DPH, Atavax, Depo Medrol injects;
Hep A vaccine led to 12cm x 8cm erythematous, indurated patch at injection site-started day post injection no fever. Tx'd with Keflex x 10 days.
45 min after vaccine administration reports intense headache 10/10 across temple area, no breakfast this morning, vomited x1, then itching,  placed in w/C and in exam room with low light, provider examined, administered po Benadryl and Tylenol po, monitored.  At 11:30 reports feeling better, discharged to home via family.
Intermittent pain in left arm/shoulder and left breast, internal, feeling like spasm in vein or similar, middle of night, woke me up from sleep, also slight heaviness in chest feeling, but no other symptoms
She had a rash, swelling, itchiness, and redness in the spot where she received my vaccine. It started about 8 days after the vaccine shot and went away 2-3 days later.
Patient was given the H1N1 nasal mist (1st dose) with no apparent adverse reactions. At 10pm @ home hives developed on Rt arm (3) L arm (2) L wrist (1). AM L forearm (1) and upper L eye brown (1). Seen by pediatrician, given BENADRYL on 1/13/10. 1/14/10 some fading of hives. Hives improving no new break out.
Received COVID vaccine on 1/7/2021 on  1/10/2021 I had a sudden onset of right side facial numbness.  I was worked up in the ER for a possible stroke but all testing was negative. The numbness lasted 3 days and has now resolved.  My COVID shot was given in the right arm.
Client returned to clinic today 9/14/00 stating that since 9/6/00, the day after he received vaxs, he has experienced malaise, vomiting, and headaches. Client was sent to Urgent Care Center.
after about 5 days I developed a huge red welt at the injection site. The welt was about 5 inches in diameter and was hot and itchy. it lasted for a few days. I took Zyrtec and it got better after a few days.
Itchiness (Covid arm); Rash (Covid arm); A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and  experienced rash (vaccination site rash), and itching (vaccination site pruritis).    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 25 Feb 2021, approximately 8 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.   On 04 Mar 2021, the patient began to experience "COVID arm" detailed with a rash and itchiness at the injection site.  Treatment information was not provided/unknown.   Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The outcome of the events were unknown/not reported.
Arm is very sore and started running a low grade fever 101F. Took 325mg acetaminophen.
Information has been received from a physician concerning a 13 to 19 month old who, "about seven weeks before the patient's experience," in approximately June 2006, was vaccinated with a 2 ml oral dose of Rotateq. "About six months ago, about seven weeks after receiving Rotateq," in approximately August 2006, the patient developed bloody stools. It was noted that the physician thought that the event may have been related to a milk allergy and the event stopped after the patient stopped milk intake. It was reported that the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Upon internal review, the patient's experience was considered to be an other important medical event. Additional information has been requested. The physician indicated that the event had already been reported to VAERS.
Severe, acute neck pain/stiffness. Current as of this report - 7 days.
Approximately 12 days after vaccination, he developed a soft tissue growth at the area of injection.  No signs of induration, infection, or inflammation.  No signs of clot.  Presents as a lipoma, but was not present previously.  It does cause him to have some discomfort.
Pt states day after received second TWINRIX started with fever & irritability, on 21st had facial numbness, knot in L cheek and ulcers on roof of mouth.  Saw MD, no medications given.
tested positive for covid; tested positive for covid; Serious: No This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 05Dec2021 (Lot number: FJ1620) as dose 3 (booster), single, administration date 10Apr2021 (Lot number: EW0162) as dose 2, single and administration date 20Mar2021 (Lot number: EN6955) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "tested positive for covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: I have tested positive for covid. I dont understand how.  No follow-up attempts are possible. No further information is expected.
Hives 3 days after injection, angioedema of upper lip 5 days after injection
Menstruation began not long after vaccine. Bleeding was heavy and cramping was very painful. This went on for over a year. Her periods then stopped completly. She now has to take hormones for her period to begin. I feel she will have problems conceiving when she decides to so. This is something that is going to effect her for the rest of her life.
6-19-07 Received vaccines. 6-20-07 Right arm swollen from shoulder to elbow, hot to touch. 6-21-07 Saw doctor who determined it to be an allergic reaction of local type to vaccine given in the right arm. 6-23-07 Swelling gone from arm. 6-25-07 Mother reports it is still achy.
Prompted seizures to reappeared. Hadn't had any seizures for months until vaccinnation was administered. Seizures lasted for most of the week. Seizures started the same day the vaccination was given.
Patient experienced redness, swelling, & warmth at injection site. She was advised to go to urgent care. She was ultimately treated for cellulitis.
LEFT ARM BECAME COLD; LEFT ARM BECAME NUMB; This spontaneous report received from a patient concerned a 25 year old female. The patient's weight, height, and medical history were not reported. The patient experienced drug allergy when treated with cefalexin, and azithromycin for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811 and expiry: UNKNOWN) dose was not reported, administered on 10-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-NOV-2021, the patient experienced left arm became cold. On 10-NOV-2021, the patient experienced left arm became numb. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the left arm became cold and left arm became numb was not reported. This report was non-serious.
Pt experienced pain/swelling/rash right away but didn't seek medical treatment. That subsided but 5 to 6 days later she started experiencing nerve pain shooting down her arm. She self treated with ADVIL and it improved over time. It was resolved by September 2017. Pt never consulted any medical provider.
Strong pain on left arm and shoulder, it started 2 after the vaccine, and is still present, it had never hurt like this.
Flushed, hot Seen by onsite EMT. Pt. released at 4:32
health deteriorated; unpleasant experience; This case was reported by a consumer via interactive digital media and described the occurrence of general physical health deterioration in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for covid-19 prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of COVID-19 VACCINE. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced general physical health deterioration and feels awful. On an unknown date, the outcome of the general physical health deterioration and feels awful were unknown.   It was unknown if the reporter considered the general physical health deterioration and feels awful to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient received the first Shingles vaccine after four months of the second Covid vaccine and noticed that his/ her health was deteriorated. The patient stated that he/ she would not take the second shingles dose. The patient also stated that more research needed to be done on shingles and Covid vaccines taken couple months apart. the patient did not had a pleasant experience. It was unknown if the reporter considered the general physical health deterioration and feels awful to be related to Covid vaccine.
Information has been received from a health professional concerning a female who was vaccination with a first dose of Gardasil. Subsequently the patient fainted. Subsequently, the patient recovered from fainted. Additional information has been requested.
pt recvd vax & c/o of heart pounding; rapid pulse; flushing ringing in ears; numbness in fingers bilat sense of doom; to er;  c/o redness; warmth; induration size of lemon; tenderness in LA;
rash onset 10NOV92; started on face, chest, back & moved downwards; rash on thighs today, t99.8; minor sore throat, n/v, diarrhea & abdo cramps on day of vax; DPH given; achiness in both wrist; numb, inability to walk or put wt on lt leg;
Initial healthcare professional report received on 01 Feb 2010: This patient was vaccinated with H1N1 INFLUENZA virus vaccine (manufacturer unknown) on an unspecified date. On an unknown date, the patient presented with stridor respiration, tachycardia and right and left sided jaw pain. Halter monitor and stress test results showed spurts of supraventricular tachycardia with a heart rate of 60 to 137 BPM. At the time of this report, the patient had right sided jaw pain and tachycardia. There were no more stridor respiration. Final outcome for tachycardia and jaw pain was reported as condition unchanged and complete recovery for stridor.
104 fever, severe body aches lasting 12 hours Did not have a period for 2 months after receiving the second dose. No positive pregnancy tests- can only be attributed to the vaccine.
Narrative: Patient noted with reaction to receiving second dose of Moderna this afternoon. He received the vaccine approximately 1:07 PM and his wait time was to 1:22 p.m. Observation nurse noted that patient was fanning himself and complained of an itchy throat and became flushed. Patient brought immediately to triage room where he began having seizure-like activity and became unresponsive. EMS called 6-25-21 Contacted patient to check ob status after reaction post covid vaccine 6-24-21. States the ER evaluated and released him and feels fine today no further reactions to report at this time, and platient placed on O2. Eased to floor in case CPR required. Patient was administered 0.3 mg EpiPen at 1:30 PM IM and he received a second dose at 1:40 PM IM. Patent received Benadryl 50 mg IM at 1:43 PM. Patient maintained a pulse in the 60s except for a brief period between the EpiPen shots where his pulse was nonpalpable for approximately 3-4 seconds. AED had been used to check patient and he did not require shock. Patient was noted to have agonal breathing on and off. He had 3-4 rescue breaths and sternal rubs and was able to be returned to breathing on own with pulse oximetry dropping to the lowest of 84% during agonal breaths and returning to 88-93 % otherwise. BP 185/103 P 56. Rescue arrived within 25-30 mins of initial reaction. Patient was noted as being within SR, POX @ 93% but still having some periods of positional agonal breathing when he was left for transportation to ER.
BODY ACHES; WEAKNESS; Diarrhea; Stomach ache; SHIVERING; FEVER; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting), PYREXIA (FEVER), CHILLS (SHIVERING), MYALGIA (BODY ACHES) and ASTHENIA (WEAKNESS) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced VOMITING (vomiting), PYREXIA (FEVER), CHILLS (SHIVERING), MYALGIA (BODY ACHES), ASTHENIA (WEAKNESS), DIARRHOEA (Diarrhea) and ABDOMINAL PAIN UPPER (Stomach ache). At the time of the report, VOMITING (vomiting), PYREXIA (FEVER), CHILLS (SHIVERING), MYALGIA (BODY ACHES), ASTHENIA (WEAKNESS), DIARRHOEA (Diarrhea) and ABDOMINAL PAIN UPPER (Stomach ache) had resolved.            The adverse events lasted for 3 and a half days, and resolved on their own. Patient is doing well.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-112272 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: The events were resolved
Expired dose was given to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose was given to patient) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Janssen on 08-Mar-2021. Past adverse reactions to the above products included No adverse event with Janssen.    On 14-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose was given to patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose was given to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.  The caller states that on 13-Dec-2021, a vial of the Moderna vaccine was opened and was not disposed of properly. And on 14-Dec-2021, 3 doses were accidently administered to patients from the punctured vial. She reported that the vial was refrigerated the entire time and it was administered approximately 18 hours post puncture. It was reported that none of the patients have reported adverse reactions to this expired dose.   This case was linked to MOD-2021-414582 (Patient Link).
Moderna COVID-Vaccine EUA  Within 12 hoursof injection, soreness at injection site, fever of 101, chills, no energy. Took one extra strength Tylenol at 3:00 am, 7:00 am, 11:00 am, 2:00 pm, and 10:00 pm and slept alot until 5:00 pm. Felt normal again upon waking on May 7.
PATIENT WAS GIVEN JJ VACCINE , SHE WAS VERY AFRAID OF THE NEEDLE. SHORTLY AFTER THE VACCINE PATIENT FAINTED IN THE WAITING AREA AFTER VACCINE. PATIENT WAS GIVEN WATER, JUICE AND WAS FANNED FOR RELIEF. PATIENT STARTED FAINTING AGAIN AND AT THAT POINT THE AMBULANCE WAS CALLED. PATIENTS VITALS WERE ALL LOW INCLUDING BLOOD PRESSURE, BLOOD SUGAR AND HEART RATE. PATIENT WAS TAKEN TO THE HOSPITAL FOR FURTHER EVALUATION.
Upon awakening, the day after shots were given, he had a large red swollen area in right arm with itching. No fever.
Swelling of upper and lower eyelids, headache, dizziness, blurry vision, white spots in vision, arm that was injected became swollen.
Administration error:  J&J vaccine dose was administered to a 17 year old.  No immediate harm noted during observation period, no chart documentation of harm after discharge (as of review 11 days later).  Contributing factors for administration error:  (1) vaccine clinic was previously giving Pfizer vaccine while J&J shipments delayed.  Change to J&J led to confusion by scheduling (patient was not screened as contraindicated for the Pfizer vaccine).  Not detected onsite due to knowledge gaps given different approved age ranges.  Taking action in scheduling and onsite registration to prevent similar errors moving forward.