chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician through medical records concerning a 1 day old, 3608 gram, 21.5 inch, white male with a head circumference of 36.5 cm, who on 12-JUN-2008 was vaccinated with the first dose of RECOMBIVAX HB, 0.5 ml intramuscularly.  Concomitant medications on 12-JUN-2008 included phytonadione (MSD), 1 mg intramuscularly; and erythromycin eye ointment to both eyes.  On 13-JUN-2008 the infant was noted to be not nursing well.  His weight was noted to be 7 pounds, 11 ounces, down 3.2 %.  The child was also circumcised.  The infant was given a hearing screen and was noted to have passed the right ear.  On 14-JUN-2008 the patient was noted to have experienced some fussiness.  Also noted were approximately three to four lesions with an erythematous base and whitish center consistent with erythema toxicum.  The infants weight was noted to be 3380 grams, down 6 %.  Hearing screen was passed to the left ear.  The baby was discharged on this date.  On 16-JUN-2008 the patient was seen for a follow-up visit for weight and bilirubin.  He was initially breast fed, but did not do well, and he was changed to bottle feeding.  The parents noted that the baby was not fussy, but he wanted to eat all the time.  He experienced frequent stools.  His weight was 8 pounds.  He had gained 8 ounces in two days.  His circumcision site was noted to be healing and his skin was free of rash.  He was reported to be a healthy baby.  It was noted that his feeding pattern would need to be watched.  On 25-JUN-2008 the infant was seen for follow-up.  He continued on formula feedings.  Stools were reported to be slightly loose and slightly frequent.  The baby's exam was reported to be excellent.  There was a small umbilical granuloma noted, that was treated with silver nitrate stick.  On 12-AUG-2008 the patient was seen for a two month check up.  He was noted to be sleeping well, was on formula feedings and had no problems.  He was vaccinated with DAPTACEL (lot # C2952BA); ACTHIB or OMNI-HIB (lot #UF401AA); IPV (lot # A0805); PREVNAR (lot #C45721E); and ROTAVIRUS (lot #0209X).  Additional information has been requested.
Recurrent genital herpes outbreak 6 days after receiving first dose of the Pfizer vaccine
felt hot chills; dizziness; hard time exhaling; tired; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (felt hot chills), DIZZINESS (dizziness), DYSPNOEA (hard time exhaling) and FATIGUE (tired) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HOT FLUSH (felt hot chills), DIZZINESS (dizziness), DYSPNOEA (hard time exhaling) and FATIGUE (tired). At the time of the report, HOT FLUSH (felt hot chills), DIZZINESS (dizziness), DYSPNOEA (hard time exhaling) and FATIGUE (tired) outcome was unknown.            No concomitants were provided by reporter. No treatment details were provided.   This case was linked to MOD-2021-264195 (Patient Link).
did not achieve immunity w/1st 3 doses given 4th & 24hr later pt suffered stroke;
Administered expired  Pfizer vaccine to client.  Client was called and instructed that the dose did not count since the vaccine was expired and would need to return to the clinic for another dose.
On November 2, patient states his arms became sore.  The soreness became worse in the left arm before getting better over the last month, but still interferes with his sleep.  The right arm is worse with decrease range of motion; it continues to be a 3-4/10 on the pain scale during the day and worsens at night to a 7-8/10 on the pain scale, as it disturbs his sleep during the night.
6/6/07: Administered yellow fever vaccine SQ and Hep A vaccine IM in right arm.  Latex free bandaid applied to injection sites.  Approximately 2 minutes later, patient complained of itching at both injection sites.  Bandaids removed.  At yellow fever site, small reddened papule formed which increased in size over the next 5 minutes.  Patient complained of itching becoming worse.  Also complained of itching of eyes and throat.  Developed a cough that was not previously presnt.  Benadryl 1 ml administered IM.  Dr. in health department at the time of event and was called to clinic.  Patient improved within 5 minutes.  At 45 minutes, patient had no itching at injection site, no itching of throat or eyes.  Patient breathing well, cough subsided.  Patient discharged to care of parent.  Vital signs stable. 6/7/07:  Clinic nurse called patient and parent to inquire about symptoms.  No sypmtoms. Patient feeling well.
Bed ridden with extreme  pain in lower abdomen with chills, fever, nausea that got worse over a period of 5 days(03-19-03/24) with irregular vaginal bleeding in the middle of my birth control pack. Eventually went to see doctor due to pain and pain slowly started to ease beginning on 03/25
Initial information received on 18-Dec-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves Adult patient who experienced we are getting a cross reaction typhoid vaccine for a patient who had a reaction with DEMEROL, while received vaccine TYPHIM VI. The patient's past vaccination(s) included DEMEROL with had a reaction with DEMEROL. The patient's past medical history, medical treatment(s) and family history were not provided. On an unknown date, the patient received a dose of suspect TYPHIM VI (lot number and Expiry date unknown) via unknown route in unknown administration site. The patient developed a non-serious we are getting a cross reaction typhoid vaccine for a patient who had a reaction with DEMEROL (therapeutic product cross-reactivity) (Unknown latency) following the administration of TYPHIM VI. (Other relevant tests included No lab data.). Final diagnosis was we are getting a cross reaction typhoid vaccine for a patient who had a reaction with DEMEROL. It was not reported if the patient received a corrective treatment. The event outcome was reported as Unknown. Additional information was received on 19-Dec-2018 by the same reporter. List of documents held by sender: none.
Nausea; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced nausea. On an unknown date, the outcome of the nausea was recovered/resolved.   It was unknown if the reporter considered the nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter's friend received dose of Shingrix and next day after vaccination experienced nausea. The reporter stated that, the nausea resolved within 1 day. The reporter did not provide additional details. For the tolerance of 2nd dose, refer case US2019167041, reported by same reporter. This was 3 of 4 reports provided by the same reporter.
Pt tolerated COVID vaccine fine. RSV burned a little but during injection. Pt went out to lobby to sit in chair for 15". Noticed she was still there at 20" and she looked like she was sleeping. She was not but she said her arms and face felt "like balloons and like they had Novocain in them". SHe did not have SOB, her tongue was not swollen she did appear a little flushed but was coherent and able to walk back into the clinic. Got a set of vitals, 148/69 and HR 52--which is baseline. She said she felt numb but it was resolving. Ate a full breakfast. Declined juice and crackers. ARNP came to assess patient. She told us a bit about a syncopal/ vasovagal episode in 2018. She has a diagnosis of paroxsymal hemicrania after an MVA in her 20s. We went over any symptoms of a TIA or CVA and she agreed she felt better and would go to urgent care or call EMS if any symptoms or episodes of numbness.  We monitored her for about 40" total and she only left when she felt 100% fine and she agreed to take it easy today.
Headaches, weakness in hands, fatigue, chills. Off and on throughout the day and night starting 4 days after receiving vaccine. Combination of ibuprofen and acetaminophen helped alleviate symptoms.
Body aches, pain at injection site restricted range of motion. low grade fever x 3 days
an expired dose was administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 53-year-old female patient who received HAV (Havrix) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th November 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 16th November 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 17-NOV-2022 Reporter's Comment: The reporter consented to follow up by email. Additional Supportive Information: The patient received a dose of Havrix which was already expired on 30th September 2022, led to expired vaccine used.
No adverse symptoms were reported; Nurse reported the same patient received second dose ofGARDASIL 9 on unspecified date in 8/2017; This spontaneous report was received from a nurse referring to a male patient over the age of 18. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.   On an unspecified date in July 2016 the patient received dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, frequency, route, indication, lot # and expiration date were not reported) for prophylaxis. On an unspecified date in August 2017 the patient received second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, frequency, route, indication, lot # and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration). No adverse symptoms were reported.
Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' concomitant medication, medical history and drug reactions/allergies were not reported. On unspecified dates, the patients were administered improperly stored doses of VAQTA (lot # L023232 with expiration date 25-FEB-2017; dose and route were not reported). The vaccines were exposed to 1 degree Celsius (C) for 60 hours and 90 minutes. A data logger was used to log temperatures, and there were no prior excursions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Left upper arm - 4/2/13 small red, swollen area and warm to touch appeared per Mother progressively got worse brought to HD on 4/3/13 area now 4"x9" red, swollen, very warm to touch with small blisters. Reports afebrile but medicated with TYLENOL, decreased appetite, and fatigue. Right upper arm - red, swollen, warm to touch circular 1"-1 1/2" diameter.
fingers hurt; legs hurt; vaccine arm  aches; headache; barely able to make it to bed; delirious; soreness; whole body hurt/achy; soreness, tender in her arm; A spontaneous report was received from a consumer concerning a female patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccination site soreness/tenderness, body aches, delirium, asthenia/fatigue, vaccine arm pain, headache, whole body, arms and fingers hurt.    The patient's medical history was not provided but the mother is the caregiver. No relevant concomitant medications were reported.   On 24-JAN-2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch unknown) for prophylaxis of COVID-19 infection.  On 24-FEB-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch unknown) for prophylaxis of COVID-19 infection.  On 24-FEB-2021, 3 hours later, the patient experienced soreness, tender in her arm. By 10 pm same day, she was achy, delirious, barely able to make it to bed after brushing her teeth. Next morning, she was still achy, vaccine arm aches and had headache. Her whole body, legs, arms and fingers hurt.   No laboratory data was provided. Treatment information was not provided. Delirium is a medically significant event, hence this is a serious case.  Action taken with mRNA-1273 in response to the events  was unknown.  The outcome of the events, vaccination site soreness/tenderness, body aches, delirium, asthenia/fatigue, vaccine arm pain, headache, whole body, arms and fingers hurt, was considered as not resolved at the time of the report.; 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.; Sender's Comments:  MOD-2021-028353:Same Reporter, Different Patient MOD-2021-028539:Same Reporter, Different Patient MOD-2021-028543:Same Reporter, Different Patient MOD-2021-028562:Same Reporter, Different Patient
Initial misuse report received from a healthcare professional on 16 January 2013. A 06-week-old patient (no other information was provided concerning the patient) received a dose of ACTHIB vaccine reconstituted with MENACTRA vaccine on an unspecified date. No adverse event was reported. Documents held by sender: None.
trouble breathing; rash going down inner thighs and back; Took second dose with a gap of 94 days; armpit lump; felt panicky; itching; Welt; This spontaneous case was reported by a patient and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Took second dose with a gap of 94 days), PRURITUS (itching), URTICARIA (Welt), ANXIETY (felt panicky) and DYSPNOEA (trouble breathing) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Seasonal allergy since an unknown date. Concurrent medical conditions included Seafood allergy (Crab allergy was reported), Penicillin allergy (Allergic to penicillin, versed and anesthetics), Asthma (The patient reports she has slight asthma) and Anesthesia. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for Depression.   On 12-Jan-2021 at 2:20 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jan-2021, the patient experienced PRURITUS (itching) and URTICARIA (Welt). On 26-Jan-2021, the patient experienced ANXIETY (felt panicky). On 03-Feb-2021, the patient experienced AXILLARY MASS (armpit lump). On 16-Apr-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Took second dose with a gap of 94 days). On an unknown date, the patient experienced DYSPNOEA (trouble breathing) and RASH (rash going down inner thighs and back). On 16-Apr-2021, INTENTIONAL PRODUCT USE ISSUE (Took second dose with a gap of 94 days) had resolved. At the time of the report, PRURITUS (itching), URTICARIA (Welt), ANXIETY (felt panicky), DYSPNOEA (trouble breathing), AXILLARY MASS (armpit lump) and RASH (rash going down inner thighs and back) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Benadryl, Hydrocortisone cream 4 times a day was recommended treatment by Dr for itching, red, baseball size welt on 18-JAN-2021. On 25-JAN-2021 the reported began having trouble breathing, feelin panicky, in which Dr prescribed Medrol Pack, Benadryl, and Cortisone Cream.  Action taken with mRNA-1273 in response to the event was not applicable.  The patient also reports that she have O+ blood type.       Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Significant Follow up Appended - new reporter added
administer expired vaccine to patients, after the manufacture date of expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration.) in a 65-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that vials had not undergone any temperature excursion.  Total of 173 doses were given from LOT 070H21A. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up contains nonsignificant information
Left arm red, swollen, tender at injection site. Treatment: ORAPRED 15mg/5mL with BENADRYL.
Pt reports morning post vaccine woke up with left arm hurting at injection site and front of arm. Redness times 3 weeks, pain spread down front and back of arm. Currently complains of marked weakness in arm an pain when rotating arm.
TRANSIENT CEREBRAL ISCHEMIA ACUTE STROKE OF THALAMUS, UNSPECIFIED TYPE AND ARTERY
Bleeding at time of injection.  Later pain and bruising at injection site with goose egg size swelling and extreme soreness.
Brief episodes of arm tremors and head shaking noticed by mom after vaccines given. Admitted to hospital 3/30/11.
Experienced chest pain, neck pain, general muscle pain, joint pain, some abdominal pain, headaches, fatigue, some shortness of breath, lightheadedness, some vision change in left eye, severe heartburn flare up, nausea, digestive issues (urgent, but small stools), increased heartrate, irregular tachycardia responses and heart palpitations. The pain and heartburn were treated with over the counter medications - ibuprophen, Tylenol, Pepcid and Prilosec at advice of my primary care doctor.  Most all of the symptoms resolved after about two weeks past vaccine except my heartrate/palpitations and heartburn.  My primary care doctor prescribed Protonix to help with the heartburn. Three and half weeks past vaccine I visited the ER thinking I was having a heart attack.
Tdap and MENACTRA given on L arm by medical assistant 03/13/2017. Patient came into office 03/15/17 c/o swollen L arm. Itchy and erythematous. Diagnosed w cellulitis and prescribed KEFLEX.
Pain in deltoid & triceps muscle and upper shoulder.  Weakness noted in attempting to lift heavy objects.
Vaccination at 11:15am.  Onset of soreness / flu-like symptoms around 9pm.  Patient awoke around 3am to use the bathroom and fainted (lost consciousness and collapsed) on the floor.  Patient's wife tried to help patient back into bed, once patient was standing patient lost all muscle control and experienced muscular spasms in legs (possibly arms).  Patient's wife laid patient flat on floor; patient's eyes rolled into back of head.  Patient was unresponsive for approx 1 minute, by the time wife retrieved phone to call for help, patient was again responsive and displayed extreme flu-like symptoms (severe shaking, sweating, and thirst).  Patient remained laying on ground for 10 minutes before being able to sit and return to bed.
This spontaneous report as received from a certified medical assistant refers to unspecified number of patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On 20-JUN-2016, 4 doses of improperly stored ROTATEQ lot# reported as L046320 with expiration date: 29-SEP-2017 and 1 dose of improperly stored ROTATEQ lot# L038534 with expiration date: 19-AUG-2017 (dose was not reported; orally) were administered to the patients. Administered doses of ROTATEQ underwent temperature excursions at 49.5 Fahrenheit degrees for 1 hour. Data logger was not involved. Product quality complaint (PQC) was not involved. No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested.
Started symptoms of adverse reaction in same day, weakness, aches, dizziness and severe arm pain.   Dizziness is still persisting as of 1-13-22, but with some improvement.  No syncope, no chest pain, no heart palpitations.
About 4 hours after shot got a migraine and took 2 Extra strength Tylenol and didn't seem  help.
varicella zoster left hand and arm pt has had VZVx2, no h/o varicella disease
I have had the cough and running nose; My nose is just like watery; then I have lot of mucous; Allergy; I have had the cough and running nose; This is a spontaneous report from a contactable consumer.  A 83-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EP5534), dose 1 via an unspecified route of administration on Mar2021 as dose 1, single for covid-19 immunisation. Medical history included Congestive heart failure from an unknown date. It was reported that patient take his blood pressure medicine. The patient experienced i have had the cough and running nose (rhinorrhoea and cough), my nose is just like watery; then i have lot of mucous (secretion discharge), allergy on an unspecified date. It was reported that patient have had the first shot at On Sunday and patient have second shot, but she had the cough and running nose. his nose is just like watery and then she has lot of mucous will that shot (Unspecified Vaccine) bother what she got this allergy or whatever. It was reported that patient had 2nd shot on 11Apr2021. It was reported that patient take his blood pressure medicine. patient have been taking Benadryl (Treatment) for this drainage. The patient underwent lab tests and procedures which included blood test: unknown result on Feb2021, blood test: unknown result on Mar2021. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Left upper extremity swelling and pruritus. Chills 1st night after injection 2-14-06. Treatment-warm compress. Increase Left upper extremity- followup with physician. 2/20/06 -"much better swelling down".
Fever, joint paid, headache, cold sweats, nausea, fast breathing, no energy. I have been trying to stay hydrated. I've taken Tylenol. 1200 mg. Fever and other side effects still persist.
Pt presents for follow-up of right hip and leg pain.  He had an epidural injection which she says did not help.  More recently has had increasing right hip pain he now is unable to walk he complains of severe stabbing aching pain with attempted weightbearing most in the groin and anterior thigh but also radiating down the lateral right leg.  Imaging  shows right femoral head fracture.  Will require total hip replacement.  Given his inability to bear weight pt admitted to the hospital. Pre-op covid test positive. Patient asymptomatic.