chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received a dose of MENACTRA instead of the MMR vaccine with no reported adverse event; Initial information received on 16-Nov-2021 regarding an unsolicited valid non-serious case from an other health professional via Media Information (under the reference 00860685).   This case involves a 12 months old male patient who received a dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] instead of the MMR VACCIN (wrong product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) and HIB VACCINE CONJ (TET TOX) (ACT-HIB) (lot number and expiration date not reported) via unknown route in an unknown administration site for Prophylactic vaccination.  On 15-Nov-2021, the patient received a dose of suspect MENACTRA (0.5 ml, total, once, lot U7140BB and expiration date: 7-Nov-2022) via intramuscular route in the right thigh for Prophylactic vaccination.  It was an actual medication error due to wrong product administered (same day latency).  No adverse event was reported.  It was reported "A 12 month and 9 day old patient received a dose of MENACTRA instead of the measles, mumps, and rubella (MMR vaccine) at their visit on 15Nov2021. Caller stated the patient was mistakenly administered the MENACTRA vaccine and was not sure what to do. Caller did state that the patient has not received any other prior dose of MENACTRA. Caller mentioned that her clinic only administers MENACTRA to patients older than 11 years of age. Agent did inform caller that MENACTRA is approved for ages 9 months to 55 years of age, and that primary vaccination in children 9 through 23 months of age is 2 doses 3 months apart. Caller was provided with the normal adverse effects of MENACTRA on children 9 through 12 months of age."  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Both legs from knees down got swollen and were painful to touch, walk on, etc.; Both legs from knees down got swollen and were painful to touch, walk on, etc.; This is a spontaneous report from a contactable consumer (patient). A 66-years-old male patient received BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, Lot number EX923, in hospital, via an unspecified route of administration in left arm from 19Jan2021 at 20:45 (at age of 66 years) at single dose for COVID-19 immunization. Medical history included spinal stenosis, arthritis and allergy to penicillin, all from an unknown date. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. Concomitant medication included gabapentin, meloxicam (MOBIC), zinc, ascorbic acid (VIT C), magnesium and cinnamomum verum stem bark/elettaria cardamomum fruit/syzygium aromaticum (CINNAMOL). On 24Jan2021 at 16:00 both patient's legs from knees down got swollen and were painful to touch, walk on, etc. The event resulted in doctor or other healthcare professional office/clinic visit. The patient was treated with steroids. The reported events were resolving at the time of the report.
Pt with left upper arm erythema c/w reaction at site. Given warmth, will be treated with topical antibiotic and oral. Pt presented today, outcome unknown at this time.
Initial report received from a health care professional on 08 Mar 2010: This patient was vaccinated with expired FLUVIRIN (batch no: 1012785), (dose: unknown) intramuscularly on 05 Mar 2010. No adverse reaction had occurred.
Fever started 7/25/07 after vaccines wont eat much. Left leg red - 5/26/07 shaking after bath. Irritable - aseptic abscess - seen by doctor 5/26/07
severe pain from her neck to the top of her arm; severe pain from her neck to the top of her arm; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (severe pain from her neck to the top of her arm) and PAIN IN EXTREMITY (severe pain from her neck to the top of her arm) in a female patient of an unknown age 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NECK PAIN (severe pain from her neck to the top of her arm) and PAIN IN EXTREMITY (severe pain from her neck to the top of her arm). At the time of the report, NECK PAIN (severe pain from her neck to the top of her arm) and PAIN IN EXTREMITY (severe pain from her neck to the top of her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  No treatment medications provided by the reporter.
Information has been received from a pharmacist concerning her son with no pertinent medical history and no drug reactions/allergies who in February 2007, was vaccinated PO with a dose of Rotateq. Concomitant therapy that day included 4 other unspecified vaccines. Subsequently, 2-3 hours after vaccination, the patient was screaming and pulling on his leg. This occurred for a couple of hours. The pharmacist did not call the pediatrician. By the next day, her son was " a lot better". The patient recovered. The pharmacist mentioned that her son was breastfed exclusively during the time of vaccination. No further information was available. There were no lab diagnostic studies performed.  There was no product quality complaint. Additional information has been requested.
patient woke up with a lump under her arm on 08/28, on 08/29 she started getting rashes (hive like) and throughout the day they kept appearing in different places. she went to urgent care and got a steroid shot. there was temporary relief and the rash outbreaks came back. went to the dr on 08/30 and go steroid tabs, cream and itch tablets also. spoke to patient on 09/01 she said that the rashes are gone for most of the day but she has flare ups at night. overall feeling much better
Patient is only 16 years of age so he should have received Pfizer instead of Moderna
Tinnitus in left ear; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 14Apr2021 at 11:00 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. Medical history of the patient was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any medication within two weeks of the COVID-19 vaccine. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication and experienced drug allergy. Since the vaccination, the patient had not been tested for COVID-19. Four days after vaccination on 18Apr2021, the patient experienced tinnitus in left ear, the same side as she was vaccinated on. She had no other side effects. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event tinnitus in left ear, the same side as she was vaccinated on was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
so sick after a shot; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 03-Dec-2020.  This case involves a patient of unknown demographics who had got so sick after a shot (illness), while the patient received Influenza Vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was unknown.  On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, unspecified time after receiving the vaccine, the patient reported that he/she had got so sick after a shot (illness).   It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.      The reporter assessed the causal relationship with suspect vaccine as related.
Parent brought pt into clinic on 7/24/09 (9 days after vaccines were administered) c/o bruise and lump on R upper leg down to back of knee. Dr and nurse (myself) observed. Pt's father came in on 8/9/09 without child and reported pt had abscess on R thigh opened and drained at hospital ER; Dr is consulting with hospital-ID for ? potential relation to vaccines?
Headache; migraine; Sore arm; Body aches; Hot flashes; chills; This is a spontaneous report from a contactable consumer (patient himself). A 31-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 31 years, at single dose in left arm on 24Mar2021 at 18:00 (Lot number: EN5318) for COVID-19 immunisation. Medical history was not provided. Concomitant medications included fluoxetine and oxymetazoline hydrochloride (CLARITIN ALLERGIC) both taken for an unspecified indication. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at single dose in left arm on 02Mar2021 at 18:00 (Lot number: EN5318) for COVID-19 immunisation. The patient experienced headache/migraine, sore arm, body aches, hot flashes and chills on 25Mar2021 at 04:00. The patient had no Covid prior to vaccination and no Covid tested post vaccination. There was no treatment received. Events outcome was recovered.  No follow-up attempts are needed. No further information is expected.
First week, sore arm for several days.  Some fatigue.  That disappeared and then 6 days after the vaccination, most of the upper arm became swollen, red, itchy.  The injection area swelled the most and the skin there became quite scaly  (a diameter of at least 2 inches). The itchiness continued for 7 days, with residual itchiness remaining at this time (10 days after the first appearance). At first I tried some aspirin to see if that would help the swelling and discomfort, but I had digestive upset instead. Aspirin never does that to me, so maybe that was a residual side effect.  I am reporting this so it can be added to the statistics.
After the vaccine I woke up about 3am throwing up and had diarrah all day.  I felt so bad all day that by 9pm I went to the ER and was advised my intestines were inflamed and diagnosed with Colitis.  I was prescribed Augumentin to take for 7 days and tylenol for pain and to follow up with my PCP.
Information has been received from a licensed nurse practitioner referring to unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL (lot # K009482, expiration date 06-MAR-2017, route and dose not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
A report has been received from a Health Professional concerning a 55 year old, Female subject, who had been receiving Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on an unknown date. It was reported that inadvertently administered FLUMIST to 55 year old patient. The outcome of the event of INADVERTENTLY ADMINISTERED FLUMIST TO A 55 YEAR OLD PATIENT is unknown. The report was considered to be non-serious.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 09-AUG-2011, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the long term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 17-AUG-2013, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
soreness in my left arm; pain in my left hip joint; difficulty walking; difficulty walking and sleeping; Activities like bowling became bad enough I had to quit bowling; This case was reported by a consumer and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th February 2020, the patient received the 1st dose of Shingrix. On 12th February 2020, less than a day after receiving Shingrix, the patient experienced pain in arm and pain in hip. In February 2020, the patient experienced walking difficulty, difficulty sleeping and activities of daily living impaired. On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the pain in hip was not recovered/not resolved and the outcome of the walking difficulty, difficulty sleeping and activities of daily living impaired were unknown.   It was unknown if the reporter considered the pain in arm, pain in hip, walking difficulty, difficulty sleeping and activities of daily living impaired to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient shingrix vaccine and experienced soreness in left arm and on same day also experienced increased pain in left hip joint. This pain continued and increased for the next several days, which caused patient to have difficulty walking and sleeping. Activities like bowling became bad enough that the patient had to quit bowling temporarily. The patient made an appointment with physician. At the time of reporting pain was somewhat decreased, but patient still feel pain in that joint. The patient wanted to know whether events were reaction to the vaccine.
These were typical four month shots given. Our baby woke up the next morning with a 104.5 fever. She screamed for two days straight unless she fell asleep. She was admitted to Hospital due to refusing bottles for two days. She lost almost a whole pound and went into the ?Failure to thrive? and ?Malnourished? category.
headache,heart palpitation,chest pain,left side of my face has numbness,muscle cramsp in my legs,tingling in my hands and feet
Patient developed hives at the site of his previous allergen vaccines (described as posterior triceps area) that begin within 1-2 days of receiving his third anthrax vaccine received on 23 October 2015.
Almost immediately yesterday post inoculation, I experienced shooting pain in my left temple (initially not so severe that I couldn't drive, but the sharp pains still make me wince). It has migrated to include my right side today. Other effects: lower back pain, chills, fatigue, slight breath shortness, neck lymph nodes feel swollen and slightly sore, and my skin and eyes are much more sensitive than normal.   Hopefully tomorrow will be a brand new healthy day, and I can run in the morning.
This spontaneous prospective pregnancy report as received from a pharmacist refers to a 30 year old female patient. The patient had no pertinent medical history or drug allergies. The pharmacist reported this pregnant patient in labor with 39 weeks pregnant gestation, in an unspecified hospital, received RECOMBIVAX HB (strength reported as 10mcg/ml, lot# and dose not reported) intravenously instead of intravenous (IV) PEPCID (manufacturer unknown) on 23-APR-2014. There were no concomitant medications. The pharmacist mentioned the nurse administered the wrong medication. Last menstrual period (LMP) was approximately on 24-JUL-2013 and estimated date of delivery (EDD) would be 30-APR-2014. No adverse symptoms were reported. Pregnancy outcome was not reported. Additional information has been requested.
CHILLS; LITTLE BIT OF HEADACHE; This spontaneous report received from a patient concerned a 79 year old female. The patient's height, and weight were not reported. The patient's past medical history included: explosive gallbladder, and atrial fibrillation. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number and expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for prophylactic vaccination. On an unspecified date, following primary vaccination with covid-19 vaccine ad26.cov2.s, she experienced chills and a little bit of headache (dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855194, and expiry: unknown) dose was not reported, 1 total, administered on 29-OCT-2021 on right arm for prophylactic vaccination. No concomitant medications were reported.  On 29-OCT-2021, after receiving the vaccine, the patient experienced chills, and little bit of headache. She put on a heating pad and went to bed and the next day she felt fine. She did not have any ache or soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and little bit of headache on 30-OCT-2021. This report was non-serious. This case, involving the same patient is linked to 20220217857 (dose number in series 1 case).
28AUG95 150PM pt recv vax & had low grade fever, cold sores, myalgia approx 12hrs p/vax lasting 48 hrs;
Pfizer-BioNTech COVID-19 Vaccine EUA  metallic taste immediately following 1st IM dose
My daughter developed a fever of 103 F and had severe muscle aches, chills, red eyes the evening after receiving the flu vaccine.
At 7 days post injection I started experiencing redness and itching at the injection site. The area felt noticeably warm to the touch. The redness and itching continued to spread along the back of my arm. I am currently at day 12 post injection and the redness, warmth and itchiness is still present although it is lighter red in the center and darker red around the edges of the area. The affected area covered roughly 2/3 of the back of my arm.
The initial case was missing the following minimum criteria: unspecified suspect product. Upon receipt of follow-up information on 15Mar2017, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer reporting for herself. This 65-year-old black female consumer received PREVNAR 13 (lot: R28320, expiry date: Feb2018) on 09Mar2017, around 1 or 2 P.M., in right arm, at single dose, for immunisation.  No other vaccines were given on the same day or within 4 weeks. Medical history included ongoing diabetes, knee replacement, hip replacement, spinal stenosis, ongoing blood pressure abnormal, ongoing nerve pain and ongoing sinus disorder. The patient previously took an unspecified pneumococcal vaccine on an unknown date, for immunization, experiencing no adverse effect. Ongoing concomitant medications included insulin aspart, protamine (NOVOLOG MIX 70/30) 24 IU twice a day shot, for diabetes, fast acting insulin aspart (NOVOLOG) sliding scale if bood sugar high, for diabetes, losartan 50 mg once per day, for blood pressure, metoprolol succinate (TOPROL XL) 25 mg once per day, for blood pressure, montelukast sodium (SINGULAIR) 10 mg once a day, for sinus, gabapentin, for nerve pain, 300 mg capsule once three times as needed, for nerve pain and an unspecified statin 10 mg for cholesterol. Since an unspecified date in Mar2017 the consumer arm was very swollen, red, painful, warm to touch, she felt almost kind of flu like symptoms and she had fever. She took her temperature on 14Mar2017 evening and it was 99.8. She noticed the redness to her right arm one or two days after the injection. The pain started two days after. The pain was the worst four days after; the arm was so painful that she could barely move her arm. At time of report the pain was not so severe. She was prescribed tramadol 50 mg up to three times a day as needed for pain. It took a while for it to help calm it down. No ER or physician office visit were required. The consumer measured blood cholesterol which was 10 mg on an unspecified date in Mar2017. Pain and swelling were resolving and redness had not yet resolved at the time of report. The outcome of the other events was unknown. She was informed by the Pharmacy that she would need a follow-up vaccine in a year, it was the same vaccine, but they were probably referring to PNEUMOVAX 23. It was recommended by her diabetes doctor.
mild fever ache at injection site day of vaccination, lasting two days. Extreme tiredness that has lasted so far 6 days. I have slept 13 of the last 24 hours.
27 weeks gestation, 1st pregnancy. Reaction: redness at site of injection (size is increasing), firm bump at site of injection, warmth.
Body aches; Arm soreness at the vaccination site; Extreme fatigue; Headache; This is a spontaneous report from a contactable healthcare professional, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8735) via an unspecified route of administration in the left arm on 03Apr2021 at 15:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient previously received acetyl salicylic acid (ASPIRIN), ampicillin (MANUFACTURER UNKNOWN), nifedepine (MANUFACTURER UNKNOWN) and stone fruits (MANUFACTURER UNKNOWN) for unknown indication on unknown date and experienced drug allergy. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), clarithromycin (CLARITIN) and budesonide (NASOCORT) all for unknown indication on an unknown date and unspecified medication for birth control on an unknown date. 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 the vaccination. On 04Apr2021, the patient experienced arm soreness at the vaccination site, extreme fatigue, headache and body aches. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events arm soreness at the vaccination site, extreme fatigue, headache and body aches were resolved with sequelae on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.