chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2015US000664 is an initial spontaneous report from a pharmacist received on 05 Jan 2015. This report refers to a 71-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 145205) at a dose of 0.5 ml intramuscularly on 12 Oct 2014. It was reported that the patient FLUVIRIN which reached below 36 F for 3.5 non-consecutive days and the vaccine reached 33.1 F for less than 12 hours. The pharmacist did not believe that the vaccine was frozen and thought it was a thermometer mal-function. No adverse event reported following this medication error.
This spontaneous report as received from a registered nurse (R.N.) refers to a patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX23 (lot # H013581, expiry date 03-MAR-2014). The nurse reported that about 6 patients have experienced adverse reactions from PNEUMOVAX23 with lot# H013581, exp 03-MAR-2014 and requested lot# check for this particular lot #. The nurse did not have detailed individual patient information but she said 6 patients experienced redness and rash around injection site and a couple of patients experienced fever as well. The patient sought for medical attention via an office visit. The outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Patients mom intentionally filled out vaccine form with wrong date of birth so that her child would receive the vaccine.  After the second dose, the mom again stated that the insurance had patients date of birth wrong. The doctors office was contacted to confirm date of birth.  The doctors office confirmed that the child was 11 not 12 years of age.
Red swelling about 2 inches below the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A female patient received pf-06928316 (ABRYSVO), on 10Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 11Sep2023, outcome "unknown", described as "red swelling about 2 inches below the injection site". Additional information: The patient reported she just got RSV (vaccination) today and now has a huge red swelling about 2 inches below the injection site. The patient would like to know if this is a normal reaction.  The information on the batch/lot number for pf-06928316, has been requested and will be submitted if and when received.
Patient came back to pharmacy with redness and swelling at injection site that has lasted longer then 2-3 days as stated by GSK. Patient is not in pain and its not itching - just red and hot to touch.
pt recv vax 21JUN95 & 5MAR97 pt exp a rash progressing to full blown chickenpox;pt sibling was also vaccinated w/varicella vax & had a similar exp WAES 97031819;
104 fever, fatigue, chills for 3 days. 99-101 fever for 14 days. Hasn't resolved.
Body aches, headache, fever, shaking chills, nausea, swollen, hot area 4 by 5 inches left arm. Normal arm soreness after a vaccination.
Headache, SORENESS, REDNESS, SWELLING AT INJECTION SITE SECOND TO FOURTH DAY . HEADACHE 3 DAYS. NAUSEA AND DIPHORETIC SECOND DAY Narrative:
side effects that are like the flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (side effects that are like the flu) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (side effects that are like the flu). At the time of the report, INFLUENZA (side effects that are like the flu) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
pt recv vax & devel elevated liver enzymes following vax w/Hep B; in f/u pt stated that had no f/u info on this experience; No further details were provided;
Intermittent Cough (new onset) I did not see it on the list of common side effects.  Not sure if its of concern or not. Started approx 8 hrs after vaccine.     Other symptoms I have appears to be normal such as site soreness, fatigue and mild headache. Just wanted to make you aware of cough.  Day #1  still.    Thanks!
6 x 2 1/2 cm light erythemic reaction  has a 2 cm red knot in center of left deltoid
Pt States he  has had consistent pain after 3 weeks of receiving flu shot.  He presents with a  pain scale of 5 and an 8/9 when he lifts his arm.  Pt states no signs of infection at injection site. We advised him to start OTC NSAID or pain medication and to report to PCP if pain doesn't go away.
Initial case was received from a healthcare professional, who mentioned the event and provided no other information, (not medically confirmed) on 19 April 2013; and the consumer called immediately after to provide the following information. A female infant received dose three of an intramuscular injection of diphtheria, tetanus and pertussis vaccine, manufacturer and lot number unknown, (site and side not reported) on an unspecified day in March 1988. The patient stated her mother stated she went limp after the third vaccine in the baby series for tetanus, with no other symptoms, on an unspecified day in March 1988. The doctor called it a petit mal seizure at that time. The patient had no past medical history or allergies; and no illness at time of vaccination. No laboratory, diagnostic testing or treatments were reported. The patient's outcome was reported as recovered on an unspecified date. Documents held by sender: None.
Stomach Ache; Diarrhea; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach Ache) and NAUSEA (Nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002S21A) for COVID-19 vaccination.     Concomitant products included DOCUSATE SODIUM (COLACE), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), CALCIUM CARBONATE, ERGOCALCIFEROL (CALCIUM/VITAMIN D [CALCIUM CARBONATE;ERGOCALCIFEROL]), PHENYTOIN (DILANTIN [PHENYTOIN]), CHLORPROMAZINE, PLANTAGO OVATA (METAMUCIL [PLANTAGO OVATA]), MIRABEGRON (MYRBETRIQ), OMEPRAZOLE, SIMVASTATIN, PARACETAMOL (TYLENOL), MAGNESIUM HYDROXIDE (MILK OF MAGNESIA) and ALUMINIUM HYDROXIDE, MAGNESIUM HYDROXIDE (MAALOX ALUM MILK) for an unknown indication.    On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NAUSEA (Nausea). On 14-Aug-2021, the patient experienced DIARRHOEA (Diarrhea). On 17-Aug-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach Ache). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea, at an unspecified dose and frequency and LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhea, at an unspecified dose and frequency. On 14-Aug-2021, DIARRHOEA (Diarrhea) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (Stomach Ache) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
I began about 8 hours after the shot to feel like a bump, what felt like in my tongue, left front not quite on the side. It began to get larger over the course of the evening and bigger by morning, my tongue was slightly swollen. It was never close to pea size, I would say 1/4 of that. Later in the day the bump area had what looked like an open sore and then later in the evening it was a white ulcer like sore. Last night 03/29/2021 I started to get a bump on the right side of the rim of the lip. This has not gotten any bigger nor opened to a sore.
She had just a little soreness for one day; This is a spontaneous report from a contactable Nurse (patient herself). A 68-years-old female patient received first dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6198; Expiration Date: unknown) via an unspecified route of administration, administered in Arm Left on 19Feb2021 (early afternoon for both, like 2-3 pm) (at age of 68 years-old) as DOSE 1, SINGLE for COVID-19 immunization. No medical history and concomitant medications were reported. Patient's medical history (including any illness at time of vaccination) was reported as no. There was not history of all previous immunization with the Pfizer vaccine considered as suspect nor any additional Vaccines Administered on Same Date of the Pfizer Suspect. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced she had just a little soreness for one day on an unspecified date in Feb2021. It was reported that, patient had the first shot on 19Feb2021 in her left arm. She had just a little soreness for one day. She thought of going to an orthopedist. She looked it up, and it sounds exactly like COVID shoulder which was kind of like bursitis that goes away within 1-2 years. It Has gotten a little better but she has lost some range of motion. She had troubles shaving under her arm. Caller was unsure of the seriousness. She was worried about getting the booster.  She really did not want a cortisone shot. She did go ask the pharmacist if she could get it in her hip instead of the arm for the booster. He told her they were not trained to do that. The adverse event did not require a visit to emergency room or physician Office. There was no any relevant tests. The outcome of event was recovered on an unspecified date in Feb2021.  Follow-up attempts are completed. No further information is expected.
chills; low grade fever; extremely exhausted; slept most of the day; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 24Mar2021 at 09:15 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included inflamed kidney (right side). Concomitant medications included ethinylestradiol (+) norgestimate (ORTHO TRI-CYCLEN LO), vitamin D NOS (MANUFACTURER UNKNOWN) and sertraline (MANUFACTURER UNKNOWN) for an unknown indication and from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the right arm on 03Mar2021 at 09:15 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. On 25Mar2021, the patient woke up at 02:00 with chills which then felt like it turned into a low-grade fever. The chills went away in the early morning, but then the patient was extremely exhausted and slept most of the day. The patient reported that she felt better the following day. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of the events chills, low grade fever, extremely exhausted and slept most of the day were recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
severe bruising began 1mo p/vax seen by local MD & referred to another hosp;dx ITP;required steroid therapy
Administered subcutaneously; This case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a adult male patient who received Herpes zoster (Shingrix) (batch number 3922H, expiry date 17th February 2024) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 07-FEB-2023 Reporter's Comment: The reporter called stating that the Shingrix vaccination series was administered subcutaneously (wrong route of administration). Additional Supportive Information: Shingrix administered subcutaneously, which led to intramuscular formulation administered by other route.
weakness; lightheadness/dizziness; Headache; fatigue; pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), DIZZINESS (lightheadness/dizziness), HEADACHE (Headache), FATIGUE (fatigue) and VACCINATION SITE PAIN (pain in arm) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included TIA (It was a slight blood clot that disappeared after 30 minutes and he was released from the hospital after two days of observation.) on 06-Dec-2020 and Clot blood. Concurrent medical conditions included Migraine headache, Blood pressure and Cholesterol. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol, METOPROLOL for Hypertension, RIVAROXABAN (XARELTO) and CLOPIDOGREL BISULFATE (PLAVIX) for Thrombus.   On 22-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weakness), DIZZINESS (lightheadness/dizziness), HEADACHE (Headache), FATIGUE (fatigue) and VACCINATION SITE PAIN (pain in arm). At the time of the report, ASTHENIA (weakness), DIZZINESS (lightheadness/dizziness), HEADACHE (Headache), FATIGUE (fatigue) and VACCINATION SITE PAIN (pain in arm) had resolved.            Treatment information were not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: TCR form includes Outcome of the events as resolved.
On 9/28/08 he developed a tremor and stopped walking. Tremor persisted through 8/24/09   10/01/09 PCP medical records, consults received DOS 9/22/09 to 6/10/09. Assessment: Viral upper respiratory infection. Tremor-post vaccine. Ataxia. Parent states child began to fuss, then arms and legs began to shake. Jerky movements. Erythematous diaper rash. Diarrhea. Anterior cervical lymphadenopathy. Sleeping more than usual. Cold sweats. Tremor when reaching for objects. Neutropenia. Pharyngitis. Legs stiff. Trouble walking. Unsteady gait. Liver palpable.
Physical exam showed scattered lesions with classic tear drop shaped pustules in crop formation. Patient presented with mild fever and itching with onset 3 days prior, total spots less than 2 dozen spots.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around January 2016, the patient was inoculated with the ZOSTAVAX vaccine (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles. In approximately 2016 [reported as "shortly after" receiving the ZOSTAVAX vaccine], the patient suffered a stroke. The outcome of the stroke is unknown. As a direct and proximate result of the ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using the ZOSTAVAX, including but not limited to, pain and suffering for severe and permanent personal injuries sustained by the patient. The patient has also experienced mental and emotional distress due to resulting physical limitations and the seriousness of the patient's condition. Upon internal review, stroke was determined to be medically significant. Stroke was considered to be disabling. Additional information has been requested.
LOSS OF APPETITE/ANOREXIC; FELT HOT; NOT MYSELF; MALAISE; TIRED; DIARRHEA; SHAKES; SWEATING; CHILLS; FEVERISH; SICKNESS; This spontaneous report received from a patient concerned an 80 year old female. The patient's height, and weight were not reported. The patient's past medical history included high blood pressure, high cholesterol, low thyroid, illness, and hospitalization, and concurrent conditions included penicillin allergy, cbd (cannabidiol), and chronic hives, and other pre-existing medical conditions included patient may have had covid or the flu or some virus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: 21-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced shakes. On 08-APR-2021, the subject experienced sweating. On 08-APR-2021, the subject experienced sickness. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced feverish. On 09-APR-2021, the subject experienced diarrhea. On 16-APR-2021, the subject experienced loss of appetite/anorexic. On 16-APR-2021, the subject experienced felt hot. On 16-APR-2021, the subject experienced not myself. On 16-APR-2021, the subject experienced malaise. On 16-APR-2021, the subject experienced tired. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shakes, diarrhea, sweating, chills, and feverish on 10-APR-2021, and loss of appetite/anorexic, felt hot, not myself, malaise, and tired on 18-APR-2021, and the outcome of sickness was not reported. This report was non-serious.
Cellulitis at the vaccine site with fever of 99.7 on 11/24/06 after Pneumovax given 11/20/06.
Information has been received from an other health professional, for VARIVAX (Merck), a Pregnancy Registry product, concerning a 44 years old female patient. The patient's history of previous pregnancies and live births was not known. The patient was vaccinated with a dose of VARIVAX (Merck) (lot # not provided) approximately in September 2012 "within the last 3 months". No other co-suspects were reported. No concomitant medications were reported. Subsequently, the patient became pregnant with an LMP of 29-OCt-2012 and an EDD of 05-AUG-13. The patient was seen in office on 07-DEC-2012 to confirm the patient was pregnant. The patient was exposed to VARIVAX (Merck) during trimester 1. It was reported that the patient had 5.5 weeks gestation. Additional information has been requested. Follow-up has been received from physician on 13-NOV-2014. Reporting physician stated that the pregnancy ended in a miscarriage at 6 weeks (approximately on an unknown date in December 2012). Patient was exposed during first trimester. There is a notation in the patient's chart about a D and C (dilation and curettage) taking place in January 2013. On an unknown date testing was done on products of conception and a trisomy 21 indicator was found. The physician stated he feels VARIVAX (Merck) did not contribute to the miscarriage, the patient's age and trisomy 21 issue with fetus, was more of an issue. This is one of 2 reports received from the same reporter. Additional information has been requested.
pt recvd DTP vax in rt thigh; local swelling w/o redness; DTP given 22FEB93 to ER 23FEB because of crying; T 104
The day after the vaccines were administered, pt. had a quarter sized, raised, red area on his right arm.  He received the Tdap and HPV vaccines in this arm. The second day the redness expanded and swelled about 4x more than the previous day. Today is day 3 and the swelling has increased despite using ice and Benadryl.
improperly stored; This spontaneous report was received from a nurse and refers 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 03-APR-2020, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) albumin status: rHA, lot # S006048, expiration date 27-FEB-2021 (dose and route of administration were not reported) for prophylaxis. The administered dose of vaccine underwent the temperature excursion of 47.3 degrees Fahrenheit for 14 minutes. Data logger was involved. There was no previous excursion.
HIGH BLOOD PRESSURE; EDEMATOUS ANKLES BILATERALLY; SHORTNESS OF BREATH; HEART WAS RACING; SHAKING AND TREMORS; This spontaneous report received from a patient concerned a 68 year old female. The patient's weight was 135 pounds, and height was 66 inches. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the patient experienced shaking and tremors. On an unspecified date, the patient experienced high blood pressure, edematous ankles bilaterally, shortness of breath, and heart was racing. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) high, and Heart rate (NR: not provided) Rapid (increased). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking and tremors on MAR-2021, and the outcome of high blood pressure, edematous ankles bilaterally, shortness of breath and heart was racing was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
163/75, P71, O2 97%, stated "dry throat", feels like its closing. 1055 dexamethasone 4mg administered stated allergy to iodine penicillin latex remained verbally responsive 1059 c/o headache, states hypertension medication taken this AM. No dysphagia, swallowed tablet and drank water without difficulty. States lymphedema to right arm 1100. bp 176/79 p70 o2 97% 1102 dexamethasone 4 mg po administered. facial flushing noted at 1058 1103 stated feeling better its more open now transferred to Er for further evaluation
pt recv vax; devel a few maculopapular lesions which lasted a "couple of days;
Pt recvd vax 4FEB92 & devel fine rash on face, abdomen; no inc fever 11FEB92; tx; observe if any inc fever APAP 4-6 hrs see MD;
He began running a fever, vomiting, severe diarrhea, and other flu-like symptoms for over 3 weeks post vaccination.