chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3 days ago received Moderna vaccine L arm, the following day L eye swelled shut and was painful. Gradually better each day, but still a little swollen. Vision fine. Has been placing hot compresses  L upper lid margin-mildly edematous and erythematous with tiny punctate white lesion on underside of lid
Medical Assistant administered an expired vaccine to patient. Zoster vaccine expired 1/8/17, date given 1/23/17. Lead physician notified immediately. Letter mailed to patient.
Patient received FLUVIRIN 2011-2012 instead of FLUVIRIN 2012-2013.
TRUMENBA given at 10:17 AM in left deltoid. Patient reports that in the evening she began to have body aches, redness at site of injection, fever of 100.2. Patient reported that area of redness was the size of a baseball, raised and warm to touch. Had body aches severe enough to make it difficult to walk. These symptoms occurred for a period of time of 4 days. Parent called office at 6:08 PM on 6/19/18 and spoke to triage nurse who gave instructions to give ibuprofen, tepid bath or shower, ice pack to area of redness. To ER if symptoms worsen overnight. No other calls or visits to the office until came in today 8/27/18 for a physical when patient again reported the adverse event to us. Patient is hesitant to receive any further vaccines. Today was scheduled to receive MENACTRA and Hepatitis A vaccines. We contacted Public Health and spoke to Epidemiology. They stated that patient should receive both the Hepatitis A and the MENACTRA. There should be no problems with the MENACTRA. Also, did not consider the reaction as a severe allergic reaction to TRUMENBA and would recommend that the booster dose be given at 6 months after #1 TRUMENBA. Epidemiology also recommends that patient remain in the office for observation for a period of time after receiving booster dose. Provider contacted patient but we are not certain at this time if she will agree to have the booster dose of TRUMENBA.
Flu shot given on 12/17/04 , two or three days later patient developed redness at site. The patient visited her PMD and was given Cephalexin 500mg BID for 10 days. Follow up on 01/10/05, the patient states site is without complication.
Itching and mild swelling of rt lower lip which started within 5-6 mts  after the vaccine. Itching stopped after  1-2 hrs but swelling got better after 24 hrs . Did not progress to any other symptoms.  Swelling  of the lip is still intermittent.
Mother states that at 10pm daughter had a seizure and called an amublance. Arrived at ER at 11:35 pm alert and no seizure activity noted per ER records at Hospital. Fever 103.6 rectal. Client given Tylenol and discharged from ER at 2:08 am. Mother informed us or this at 11/28/11 visit for flu shot.
Shortly after vaccination c/o being light headed, dizzy, feeling like she was going to pass out.  Slept 2-3 hours, R arm hurt, did not seek medical attention.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 23-JUL-2012, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 23-SEP-2016, the patient was treated at a doctor's office by a physician for the onset of a vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed acyclovir and hydrocortisone for the management of her painful symptoms and chronic pain. As a direct and proximate result of the 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. Additional information has been requested.
Heart palpitations, could not stand taken by ambulance to ER; discharged home after 3 hours with prescription for metoprolol, advised to see PCP. Patient went to PCP who referred to cardiologist, scheduled for halter monitor on 05/17/2021, stress test and echocardiogram on 05/24/2021.
10x8cm induration with redness, tenderness and warmth around injection site right deltoid.
FLU-LIKE SYMPTOMS; FATIGUE; PLAQUE PSORIASIS FLARE-UP; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe chronic plaque psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. No concomitant medications were reported. On OCT-2021, the patient experienced plaque psoriasis flare-up. On an unspecified date, the patient experienced flu-like symptoms, and fatigue. Treatment medications (dates unspecified) included: calcipotriol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from flu-like symptoms, and fatigue, and had not recovered from plaque psoriasis flare-up. This report was non-serious.
7/8/21: Around 4:30pm became flushed and hot. 30 minutes later minor wheezing followed by itching on neck and upper back. Took 2 Benedryl and symptoms resolved. 7/10/21: Began experiencing tightness in chest, difficulty taking a deep breath. Asthma hasn't been this bad in well over a decade. Albuterol provided only short term relief. Benedryl provided more relieve and for longer period but symptoms persisted. 7/14/21: Met with doctor. Switched from Allegra to Zyrtec. Added Qvar on top of Symbicort.  Will have checkin in a few days. If there's no improvement, the plan is to start prednisone.
Irritability followed by low-grade fever initially. Progressed to extreme irritability/crying, fever that ranged daily from low-grade in the morning to high (103+) at night , loss of appetite, diarrhea, fatigue/listlessness. Today (~6 days after symptom onset) fever has been gone <24 hrs but irritability, fatigue, loose stools, and loss of appetite persist, and a slight rash (primarily on back and chest) is observed.
On the day after the vaccine, early in am, I  began experiencing stomach crramps, body chills, headache and fatigue,  The symptoms continued until evening but subsided by evening and were gone by the next morning.  I ate normally, drank lots of liquids and took one dose of XSTylenol.
She had little to eat and lost 4 pounds; She felt "yucky; She had little to eat and lost 4 pounds; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EATING DISORDER (non-serious), WEIGHT DECREASED (non-serious), outcome "unknown" and all described as "She had little to eat and lost 4 pounds"; TASTE DISORDER (non-serious), outcome "unknown", described as "She felt "yucky". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Itchy arms; Itchy legs; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 21Mar2021 at 09:00 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient received other medication in 2 weeks which included atorvastatin (MANUFACTURER UNKNOWN) for unknown indication and start date. Patient reported unspecified allergy to food, medication and other products. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 23Mar2021 at unknown time, the patient experienced itchy arms and itchy legs after three days of vaccination. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events itchy arms and itchy legs were recovered on unknown date in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Mother of child states the following: that child was irritable in the evening and through the night on 11/30/18. Child awoke with a fever of 102 on 12/1/18 and was irritable and crying or sleeping through the day of 12/1/18. Child cried all night 12/1-12/2 and mom had to hold her all night. Around 5 AM 12/2/18 she noticed that child had difficulty holding her head up, she does not make eye contact, she is grunting and mouth is crooked. She stated the child no longer had fever 12/2 to the present. She took child to her PCP today and there was a discussion about a neurologist referral but the referral wasn't made. Per mom the PCP "didn't know what else to do". This RN informed her to call PCP back for guidance for neurologist consult or guidance to go to ER. She is planning to take the child to the ER. Mother states that the PCP informed her to no longer get any vaccines.
Initial report received from nurse on 10 Jun 2010: This patient was vaccinated with MENVEO (batch number: unknown), (dose: unknown) intramuscularly, on 09 Jun 2010. Instead of combining the diluent component of MENVEO with the lyophilized component, the patient received only the diluent component of MENVEO. No adverse effects were noted after this administration.
Dose was given to 17 years old; A spontaneous report was received from a pharmacist concerning a 17-years-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and patient received the vaccine at the age of 17 years old.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 21 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number 013L20A) intramuscularly (IM) in the right arm for prophylaxis of COVID-19 infection.   Pharmacist confirmed the age of the patient is 17 years old, not 15 as stated in the voicemail. She reports that the patient received the Moderna COVID19 vaccine on 21 Jan 2021 on right arm as IM injection. Patient reported no symptoms.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event dose was given to 17 years old was resolved on 21 Jan 2021.; Reporter's Comments: This case concerns a 17-year-old male patient who received their first of two planned doses of mRNA-1273 (Lot number 013L20A), reporting Product administered to patient of inappropriate age without any associated adverse events.
stomach cramps; first dose on 30Mar2019/was supposed to get her second dose two months after however received it on 12Jul2019; This is a spontaneous report from a Pfizer sponsored program IVR and LIve Operator Support for 1-844 TRUMENBA Customer Service Line, received from a contactable consumer. A 20-year-old female patient received second dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration in the left arm on 12Jul2019 at a single dose as school suggested to get meningitis B. The patient medical history was not reported. There were no concomitant medications. The patient previously took first dose of meningococcal group b rlp2086 on 30Mar2019 for immunization. On 12Jul2019, the patient experienced inappropriate schedule of vaccine administered. The patient reported that she got her got first dose on 30Mar2019 and was supposed to get her second dose two months after however received it on 12Jul2019. The patient reported that she received the vaccine on 14:45 (also reported as 16:45). The patient additionally reported that she had stomach cramps on unspecified date; took advil for it and stated that it was not due to the vaccine. The outcome of the event stomach cramps was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: There is not a reasonable possibility that the reported event stomach cramps is related to the suspect product
Patient felt nauseous, dizzy , lightheaded, and hot and sweaty after a minute after receiving both the HPV and TDAP. Took vitals. BP- 90/61, 90/60 pulse- 80 temp- 97.3 oral After some cool water and relaxed in the room for about 10 minutes, patient stated she was starting to feel better.
About 20 minutes post vaccine, right sided chest pain, intercostal.  Injection was in right arm; This is a spontaneous report from a contactable nurse and a non contactable physician. A 37-year-old female patient received bnt162b2 (reported as COVID-19 Vaccine, Pfizer, Solution for injection, lot no. and expiry date was unknown), via an unspecified route of administration (right arm) on 17Dec2020 13:30 at a single dose for COVID 19 immunization. The patient medical history was not reported. No allergies to medications, food, or other products. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Not pregnant at the time of vaccination. The hospital was where the most recent COVID-19 vaccine was administered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included sertraline, fish oil, colecalciferol (VITAMIN D), lactobacillus acidophilus (PROBIOTIC), and unspecified vitamin. About 20 minutes post vaccine, the patient experienced right sided chest pain, intercostal. The injection was in right arm on 17Dec2020 13:45 with outcome of recovered. There was no treatment received for the event. The event was considered as non-serious (did not result in death, was not life threatening, did not cause/prolong hospitalization, not disabling/incapacitating, congenital anomaly/birth defect.  Information on the lot/batch number has been requested.
This spontaneous report was received from a licensed vocational nurse and refers to an unspecified number of patients of unknown age and gender. No information about the patients' medical history, concurrent conditions and concomitant medications was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II lot # reported as L021655, expiry date 16-JUL-2017 (dose, albumin status, route of administration and anatomical location were not specified). The administered doses of M-M-R II underwent temperature excursion at 49 Fahrenheit degrees for 15 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient fainted/passed out a few minutes after receiving the vaccine. Mom stated patient had a little seizure. Patient retain consciousness after 1-2 minutes and did not recall what happened. She felt hot/sweaty and had minor vomiting. 911 was called. They arrived and left without any major concerns.
I have had a healthy pregnancy so far, with 2 other healthy pregnancies. I am due 4/10/2021. I woke up the morning following my flu vaccine with headache, muscle aches, and became dizzy and had to lay down as my vision was spotty and blacking out. After attempting to eat and drink, I became nauseated and vomited. Muscle aches increased throughout the day, and by approximately noon that day I had a 100.3  fever, which persisted throughout the night, during which I had chills and night sweats. The following day (today) I am still fatigued and light-headed with mild muscle aches,  no fever at this time.
Sat for15 minutes. After she got home, felt a knot on arm, broke out in sores, itchy, burning, rubbed it and skin started peeling, couldn't sleep. Stomach pains for about 2 days.
Began feeling weak, had head and neck pain, leg numbness - picked up from school by parent and taken home.  I discussed situation with Regional Immunization Program Manager, and advised patient's mother to take client to PMD for evaluation.  Patient's mother called me back at 4:30 pm - stated that patient was feeling much better after a 2 hour nap and she did not think she needed to take him to PMD. Spoke with patient's mother again today and she states patient is "back to normal," has returned to school, and was able to attend football practice this pm.
This case was reported by a nurse via call center representative and described the occurrence of fever in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and general body pain. SHINGRIX was discontinued. On an unknown date, the outcome of the fever and general body pain were unknown. It was unknown if the reporter considered the fever and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter is a nurse practitioner reporting an adverse event on behalf of the patient. The patient experienced body aches and fever after receiving the 1st dose of SHINGRIX. The patient did not want to get the 2nd dose. The reporter had limited information regarding this event and the patient at the time of the call. This case has linked to case US2018158758, reported by the same reporter.
This spontaneous report as received from a nurse and a healthcare worker refers to a 4 year old female patient. The patient's concurrent conditions, medical history and concomitant therapy were not provided. On 04-NOV-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) recombinant human albumin (rHA), lot # L030586 with an expiration date of 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a registered nurse concerning a 9 week old male with gastrooesophageal reflux precaution and no drug allergies, who on 05-SEP-2007 was vaccinated with a 2.0ml oral dose Rotateq (lot# 657660/0972U).  There was no concomitant medication.  On that same day, the patient spit up what looks like formula and clear liquid 5 minutes after vaccination.  Unspecified medical attention was sought.  The patient was noted "to be fine and went home."  There was no product quality complaint.  Additional information has been requested.
received a  late 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number x3p72, expiry date 7th November 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 01st November 2019).   On 29th July 2021, the patient received the 2nd dose of Shingrix. On 29th July 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient received a late 2nd dose, which led to drug dose administration interval too long.  The reporter consented to follow up.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 03-MAY-2016, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. Shortly after receiving ZOSTAVAX, began to experience pain and itchiness on her arms, hands, and along her back. In response to these complaints, on or about 01-OCT-2016, the patient presented to a health facility with complaints of right side pain and was diagnosed as suffering from shingles. As a direct and proximate result of these malfunctions, 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. Additional information has been requested.
Initial report was retrieved from the scientific literature on 06 September 2012. The following information is verbatim from the abstract: "Meningococci have historically caused extensive illness among members. Three successive meningococcal vaccine types were used from 1971 through 2010; overall disease incidence dropped by >90% during this period. During 2006-2010, disease incidence of 0.38 (cases per 100,000 person-years) among members was not significantly different from the incidence of 0.26 among the age-matched general population. Of the 26 cases, 5 were fatal, 15 were vaccine failures (e.g., illness in a person who had been vaccinated), and 9 were caused by Neisseria meningitidis serogroup Y. Incidences among 17- to 19-year-old were significantly higher than among comparison populations (p<0.05). No apparent change in epidemiology of meningococcal disease was observed after replacement of quadrivalent polysaccharide vaccine with conjugate vaccine in 2007. The data demonstrate that vaccination with meningococcal vaccine is effective." According to the report, the cases were confirmed by culture, PCR or both. The information included in this case concerns a 20-24-year-old male patient who had received MENACTRA (lot number, route, site and date of administration not reported) and 7 months after vaccination developed meningococcal meningitis, year reported as 2010 (Q 4). Neisseria meningitidis serogroup was determined to be serogroup C. Treatments were not reported. No further information was available at the time of report. Death was reported as "No", however the patient's outcome was not reported. The reporter for this case is the same as for cases 2012-08240, -08241, -08242, -08243, -08244, -08245, -08246, -08247, -08248, -08249, -08250, -08251, -08252, -08253, -08255, and -08256. Documents held by sender: None.
Said she had a knot in her arm and it hurt, while patient felt nauseous with diarrhea. I felt her arm today (it was red around the area that had been vaccinated) and it was hot compared to remainder of arm. She is applying ice right now. We also recommended taking an antihistamine.
GARDASIL adm 922 pt c/o feeling dizzy. 930 am SOB & become diaphoretic. Dr was called to exam pt 925 am. Pale weak pulse, vomiting x1. No LOC. Recovered progressively good pulse. Nml. BP 100/70 after 15 minute. pt initially stated numbness of L/A.