chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Inappropriate schedule of vaccine administered; Inappropriate schedule of vaccine administered; This spontaneous report has been received from an other health care professional (HCP) via medical records from a case in litigation for Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (MARRS # 2204USA002616), concerning a 6-month-old female patient (pt).  On 25-NOV-2003, pt was was vaccinated with a first dose of Hepatitis B Vaccine (Recombinant) (manufacturer unknown) (dose, units, frequency, route of administration, lot# and expiration date were not reported). On 18-FEB-2004, pt was was vaccinated with a second dose of Hepatitis B Vaccine (Recombinant) (manufacturer unknown) (dose, units, frequency, route of administration, lot# and expiration date were not reported) (Inappropriate schedule of vaccine administered). On 22-JUL-2004, pt was was vaccinated with a third dose of Hepatitis B Vaccine (Recombinant) (manufacturer unknown) (dose, units, frequency, route of administration, lot# (Inappropriate schedule of vaccine administered).
The flu shot was administered via injection into left upper arm. Immediately my face began to burn my ears turned bright red, I got dizzy and sick to my stomach. They advised me to sit down for a while (5 minutes) and then sent me home. I continued to have these symptoms for several days. However The ER refused to see me. Now it is on my allergy list......
Vulvar erosions and oral erosions with sudden appearance and ho prior history of.  Painful.  Treated with topical steroids at the moment.  Unknown how long it will take for them to improve.
Side effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Side effects) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Side effects). At the time of the report, ADVERSE REACTION (Side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Pt had swelling and pain and redness in her right arm to neck - PNEUMOVAX site. Also 101 degree F fever, HA and aches. Severe tiredness. She is getting better but still feels very tired.
Hives, body rash, itchiness occurred approx 8 hours after 2nd shot and remained for approximatley 72 hours.    Delayed menstrual cycle for over 60 days.
Per observation nurse patient returned after 15 min observation complaining of  "lump in throat" and "hard to swallow". Patient was monitored (with BP 139/93 and HR 106 at 1143. BP 147/93 and HR 106 at 1155). She was then taken to the ER for further observation per observation nurse.   Pulse ox 98%, no resp distress. Throat felt better within a few hours. No wheezing, lip swelling, no rash or hives. Discharged at 15:54.
Information has been received from a physician concerning a male patient who on 16-MAY-2006 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine.  The physician stated that the patient passed out an hour after receiving the vaccination.  The patient's outcome was not reported.  Additional information has been requested.
pt recv vax 331MAR98 & pt devel a local rxn described as an area of induration (3cm) w/itching @ the site;30APR98 pt was vaccinated w/2nd dose of vax in the rt deltoid & again exp the same local rxn;
Her right middle finger is sore; Her right middle finger is sore, red; Her right middle finger is sore, red, swollen; Right middle finger is super sore, turning purple; About 17 weeks pregnant to date; This is a spontaneous report received from contactable reporter(s) (Consumer or other nonhealthcare professional) from medical information team. The reporter is the patient. A 23-year-old female patient (pregnant) received bnt162b2 (COMIRNATY), administered in arm right, administration date 15Sep2021 16:30 (Lot number: 30130BA) at the age of 23 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "smoke during this pregnancy" (unspecified if ongoing); "Outcome of Previous Pregnancy: Live Birth" (unspecified if ongoing). Date of last menstrual period: 03Jun2021. The patient was 17 weeks pregnant at the time of exposure to bnt162b2. The patient was 15 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 10Mar2022. The patient took concomitant medications. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 15Sep2021 16:30, outcome "unknown", described as "About 17 weeks pregnant to date", PAIN IN EXTREMITY (non-serious) with onset 29Sep2021 17:00, outcome "not recovered", described as "Her right middle finger is sore", ERYTHEMA (non-serious) with onset 29Sep2021 17:00, outcome "not recovered", described as "Her right middle finger is sore, red", PERIPHERAL SWELLING (non-serious) with onset 29Sep2021 17:00, outcome "not recovered", described as "Her right middle finger is sore, red, swollen", SKIN DISCOLOURATION (non-serious) with onset 29Sep2021 17:00, outcome "not recovered", described as "Right middle finger is super sore, turning purple".  Additional information included: Medicinal product: The patient received the injection in her right arm. She was otherwise healthy at baseline and took a multivitamin (1 Tablet a day) as supplementation. Patient received vaccination Facility in Pharmacy. Prior to vaccination, was the patient did not diagnosed with COVID-19. No family medical history Relevant to AE. AE(s) not required to visit Emergency Room and Physician Office.   Follow-up attempts are completed. No further information is expected.
patient received a less than recommended vaccine volume dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number 3B2YJ, expiry date 16-AUG-2025) for prophylaxis.   On 11-OCT-2023, the patient received the 1st dose of Shingrix. On 11-OCT-2023, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: patient received a less than recommended vaccine volume dose). The outcome of the incomplete dose administered was unknown.   Additional Information: GSK receipt date: 11-Oct-2023 A pharmacist called in to request information about how to procced after a patient received a less than recommended vaccine volume dose, which led to incomplete dose administered. The provided partial information and consented to receive follow up. The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow up.
68 years old received adacel inadvertantly/no AE; Based on information previously received on 13-MAY-2020, the following information [case classification upgraded from Non-case to a Valid case and updated all the relevant fields appropriately] has been amended  Initial information received on 13-May-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 68 years old male patient who was vaccinated with DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (product administered to patient of inappropriate age) via  intramuscular route in the left deltoid on an unknown date for prophylactic vaccination [batch number U6272AA; expiry date 26-apr-2021; dosing details 0.5 ml]  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to expired vaccine used. Nurse thought the consumer was 62 years old.  At the time of report no adverse event was reported.  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 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.
Am living proof that the injection does NOT work for everyone/suspected vaccination failure; Am living proof that the injection does NOT work for everyone; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient was the reporter. The age at vaccination was not reported. The patient stated that he or she was the living proof that the injection does not work for everyone. The patient further suggested that everyone should talk to doctor first, make sure know all of the side effects and consequences of this medication. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
The first 2 days my arm was sore, I had chills and hot flashes.  The 3rd day I had both a sore arm, chills and hot flashes, dizziness and nausea. These symptoms lasted for 8 days with extreme fatigue.  I'm on several medications for RA, thyroid, stent, depression and anxiety.  I did take Tylenol for pain.  I finally couldn't take it anymore and went and saw an acupuncturist which relieved the dizziness and nausea
This case was reported by a consumer (subject's mother) and described the occurrence of general head pain in a 19-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medications included Multivitamin and Z-PAK. On 3 November 2009 the subject received a dose of FLULAVAL (.5 ml, unknown, left arm). On 3 November 2009, less than one day after vaccination with FLULAVAL, the subject experienced general head pain. On 6 November 2009, three days after vaccination with FLULAVAL, the subject experienced sore throat, productive cough, fever, weak pulse, feeling faint, serum sickness, joint pain and exhausted. The mother of the subject did not feel comfortable providing any further information at time of reporting. At the time of reporting, only partial information was provided. At the time of reporting the subject's serum sickness, joint pain and exhausted were unresolved. At the time of reporting, the outcome of general head pain, sore throat, productive cough, fever, weak pulse, and feeling faint was unknown.
OFF LABEL USE; VACCINE ADMINISTERED TO 17 YEAR OLD; This spontaneous report received from a health care professional concerned a 17 year old of unspecified sex. The patient's height, and weight were not reported. 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: 1808978 expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the patient experienced off label use. On 26-MAR-2021, the patient experienced vaccine administered to 17 year old. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and vaccine administered to 17 year old was not reported. This report was non-serious. This case, from the same reporter is linked to 20211000660.
I was tested positive for covid- 19; I had a headache; runny nose and feeling tired
Fine red rash covering both arms, legs and back. Rash began on 10/2/2016. Rash is itchy.
Very bad rash which was red and itchy under her breast area; Swollen lymph node under left arm larger than right; She thought she had breast cancer; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8729), via an unspecified route of administration, administered in left arm on 11Apr2021 14:30 as 1st dose, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported that the patient received her 1st dose of the COVID-19 vaccine on 11Apr2021. About 10 days after, on 21Apr2021, she developed a very bad rash which was red and itchy under her breast area, along with a swollen lymph node. She has gone thru several doctors to which she was currently consulting a dermatologist. She stated that the dermatologist gave her a steroid shot and took a biopsy. She was treated with prednisone which did not help, antibiotics which also did not help, and steroid shots which helped for 2 days, after which the rash went back. She is taking Benadryl and Zyrtec for the rash, to which she mentioned that Benadryl is the only thing that helped it but caused her to get sleepy. Zyrtec took hours before it exhibited the affect. She is holding off on antihistamines because she needs to stay awake during the day. She mentioned that she is feeling a little better at the time of report, the rash has lightened but was still there and still itchy, but it seems to have toned down and it is not inflamed and red. She thought she had breast cancer, the lymph node under her left arm and along the breast has a strong itchy rash and the lymph node was swollen. The patient was aware of 42-day window that is allowable. She had already rescheduled her 2nd dose to be done on 16May2021, but her doctor recommended her to delay it again, the rash needs to calm down before the booster, second shot. She is concerned of what to do if she passes that 42-day window. She doesn't know if she feels safe to take the second vaccine. The outcome of the event "She thought she had breast cancer" was unknown, and for other events was unknown.
Early around 5am Sat., the day after my vaccine, I had a very sore arm around the injection site. I had a low grade fever, body aches, headache, that all increased in severity through the day. It was so bad by the end of the night that I couldn't sleep. I felt like I had insomnia. The fever got up to 103 Saturday night, and I had taken 4 ibuprofen hours before, but it did not keep my fever from increasing nor did it relieve my aches. My normal temperature runs about 97.7 on average. I had what I guess would be some heart palpitations on Sat as well. I got increasing thirsty, even after drinking lots of water. I couldn't drink anymore though because it was making me feel nauseous. My body ached from literally my head to my toes, including my fingers. I had no idea I'd feel this bad. On Sunday I still have a fever, body aches, etc, but by end of the day they reduced in severity. On Monday I still feel sick but the fever broke and I have aches still but not as bad. I still feel like I have insomnia.
Patient stated arm was sore same afternoon, but next day was painful and unable to move. 2 days after injection arm had doubled in size and had hives. Her arm was tight as a football. She had faster then normal heart rate, shortness of breath.
tiredness began the Thursday following immunization, along with sore throat and sneezing. All symptoms were gone by Friday.
HIB administered on 10/31/22 with an expiration date of 10/24/22
Crohns disease flare again; Injection site induration; Injection site bruising; Hard ball after HUMIRA injection and was black/blue; This is a solicited report from a non-interventional based on the information received by Pfizer from AbbVie manufacture number (21K-163-3903920-00). A contactable consumer (patient) reported that a 17-years-old female patient received bnt162b2 dose 1 intramuscular on 17Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 intramuscular on 30Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 Vaccination; adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date.  Medical history included Crohn's disease flare from 2017 and ongoing. Concomitant medication(s) included mesalazine (LIALDA) taken for an unspecified indication, start and stop date were not reported.  The patient experienced crohns disease flare again (medically significant) in Apr2021 with outcome of not recovered, injection site induration in 2021 with outcome of recovered in 2021, injection site bruising in 2021 with outcome of recovered in 2021, hard ball after humira injection and was black/blue in 2021 with outcome of recovered in 2021.  The patient underwent lab tests and procedures which included blood test: unknown result on an unknown date.  The action taken in response to the event(s) for adalimumab was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of Hard ball after HUMIRA injection and was black/blue onset in 2021, Hard ball after HUMIRA injection and was black/blue onset in 2021 Crohn's disease flare again with HUMIRA(ADALIMUMAB) was a reasonable possibility.  The reporter's causality for the event(s) of crohns disease flare again, injection site induration and injection site bruising with bnt162b2 was possible.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known temporal relationship there is reasonable possibility of causal association between the reported events and the suspect drug BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Initially, headache, sore arms, general body soreness.  After two days, symptoms except headache subsisted.  Serious headache continues for 11 days.  Taking Advil 3x daily but head still hurts.
Unknown at time of vaccine. This person was fully vaccinated against Covid-19 and is deceased.
Severe muscular collapse and diagnosis of myasthenia gravis, requiring a feeding tub, after 2nd Pfizer injection for Covid-19. Hospitalized for one month.  Patient had unknown condition. Vaccine made him a vegetable and he can't eat or walk or write. Please call me.
06/09, swollen, painful ankles. 06/10, admission to hospital. Documented bilateral ankle inflammation, arthritis slowly improving with NSAID. Discharged 06/16 with continued mild active arthritis. Reactive arthritis.
Chest 'tightness', throat tightness, onset 30 min after vaccine administration  Normal sinus rhythm as per watch  Vital signs: 130/98 HR 80 Resp 16 O2sat 98 Skin signs: Warm and dry  Circulation: Cap refill <2sec  Respiratory: Breath sound clear bilaterally  Rest, monitor At 13:36 BP 120/70 HR 68 Resp 16 O2Sat 96  Skin signs: Clammy  Circulation: Cap Refill <2sec Continued to monitor. Pt back to 'normal' within 20 min. Released by volunteer MD  Disposition: Home by self  13:45 D/C with SSG Scheiber to car
blood clot in left leg, cramping and soreness, tender to the touch. currently taking Eliquis for the next 6 months
Pt stated she was light headed and feeling faint.  pt was seated and pt kept in position found. pt had no symptoms of reaction.  negative change in BP, no change in skin color. pt VS as follows. pt monitored in  without change other than slight carpal spasm which resolved without treatment.  Pt chose to decline offered further treatment. VS on incident report. pt refused further eval and left with a friend.
Positive COVID test; Positive COVID test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 9 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 07Dec2021 (Lot number: FK5168) at the age of 9 years as dose 2 (tris), single and intramuscular, administered in arm left, administration date 16Nov2021 (Lot number: FK5168) as dose 1 (tris), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Patient did not receive other medications in two weeks. Patient did not receive other vaccines within 4 weeks of COVID vaccine. Patient did not have Covid prior to vaccination. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Jan2022, outcome "recovering" and all described as "Positive COVID test". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Inner ear infection; This spontaneous case was reported by a consumer and describes the occurrence of LABYRINTHITIS (Inner ear infection) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient 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 received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 29-Mar-2021, the patient experienced LABYRINTHITIS (Inner ear infection). The patient was treated with VALACYCLOVIR [VALACICLOVIR] at an unspecified dose and frequency and METHYLPREDNISOLONE at an unspecified dose and frequency. At the time of the report, LABYRINTHITIS (Inner ear infection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Low grade Fever (99.3); Tired; chills; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade Fever (99.3)), FATIGUE (Tired), CHILLS (chills) and VOMITING (Vomiting) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced PYREXIA (Low grade Fever (99.3)), FATIGUE (Tired), CHILLS (chills) and VOMITING (Vomiting). At the time of the report, PYREXIA (Low grade Fever (99.3)), FATIGUE (Tired), CHILLS (chills) and VOMITING (Vomiting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Numbness tingling and shooting pains in bilateral arms starting day after each shot. Seems to be worse after second dose. Pain is worse. Feels like bone pain. Had fever, nausea, body aches, neck pain , ear pain, headaches, and chills starting 12hours after 2nd dose.
Pt reported swelling & pain (L) upper arm, (L) axilla and up into base of (L) neck.
Patient received both PROQUAD and VARIVAX, totaling 2 doses of varicella vaccine. Patient did not exhibit any noticeable reaction. All other vaccines given as ordered.