chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unspecified date in March 2018, reported as between the 8-MAR-2018 until 14-MAR-2018, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB injection, lot # M022077, expiration date 10-MAR-2019 (also reported as 10-MAY-2019) for prophylaxis (route and anatomical location were not provided). The administered dose of the vaccine experienced a temperature excursion in the range between 47°F to 77°F during 55 minutes as recorded by a data logger. The vaccine had not had any previous temperature excursions. There was no adverse effect reported.; Sender's Comments: US-009507513-1803USA009619: US-009507513-1803USA009620: US-009507513-1803USA009621: US-009507513-1803USA009622: US-009507513-1803USA009623: US-009507513-1803USA009624:
This spontaneous case reported by a nurse, describes the occurrence of nodule (developed a string of nodules to preauricular/zygoma injection areas where Sculptra was previously injected) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Previously administered products included for an unreported indication: Sculptra aesthetic on Mar 12, 2019. April 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On May 10, 2021, received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On May 10, 2021, patient experienced nodule (developed a string of nodules to preauricular/zygoma injection areas where Sculptra was previously injected). Patient treated with Medrol Dosepak (methylprednisolone) for nodule; unknown dosage form. At the time of the report, nodule (developed a string of nodules to preauricular/zygoma injection areas where Sculptra was previously injected): not resolved. The reporter did not provide any causality assessments or concomitant medications. Patient received 2 doses of COVID-19 vaccine in April and May 2021. Patient developed a string of nodules to preauricular/zygoma injection areas where Sculptra was previously injected.
pt recv vax 24OCT95 & devel an inject site rxn, characterized by edema, redness, warmth & tenderness;no further details were known as of the date of this report;
The expiration date was incorrectly noted when the last extension was granted by FDA. Vaccine expiration was noted as 9/28 when correct date should have been 9/21
Diarrhea, severe stomach cramps. Started 11 days after the first dose.  Had a tele-medicine visit with a nurse at my primary doctor's office. They did blood work and several fecal tests - all lab results were normal.  The gastrointestinal problems lasted about 3 weeks, with alternating bouts of diarrhea and constipation. Slowly over the past few months I have returned to normal.
This case was reported by a consumer via other manufacturer and described the occurrence of vaccination failure in a female patient who received Seasonal Influenza vaccine. On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown. It was unknown if the reporter considered the vaccination failure and influenza to be related to Seasonal Influenza vaccine. Additional details were provided as follows: This case was received via BAXALTA. This case was considered as suspected vaccination failure as the time to onset for the influenza and lab test confirmation for the strain were unknown. The patient gave consent to contact her.
Red area around and below injection site about the size of the palm of my hand.  Area is warm.  Not bothering me, not itching or hurting, just reporting for data purposes.  I'm not sure how long it has been there, I just noticed it yesterday after bathing.
Information has been received from a Physician Assistant concerning a 12 month old patient who on 19-JAN-2011 was vaccinated with the first dose of ROTATEQ and the second dose on 24-MAR-2011. The patient received the third dose of ROTATEQ at 12 months of age on 04-NOV-2011. No adverse event was reported. It was unspecified if the patient sought medical attention. Additional information has been requested. This is an amended report, the reporting status change to periodic.
46 year old  male with history of depression, polio, HTN/HLD, chronic lung disease 2/2 remote PNA, and cirrhosis suspected 2/2 schistosomiasis, who presents with 1wk of dyspnea, w/ waxing waning subjective fevers.     Per ED Note: Endorses chronic fatigue until 4/16 when he received first dose of Covid vaccine (Pfizer). Since then, pt reports persistent dyspnea, worsening fatigue. Reports 2 days of left-sided chest pain w/ periumbilical abd pain and enlarging abdomen. Pt believes these are 2/2 covid vaccination. Chest pain is described as constant generalized discomfort under left breast that worsens with pressure. Also worse with deep inspiration. No radiation or migration since onset. Pt describes abdominal pain as periumbilical tightness, "pain". Describes subjective, unmeasured fevers that "come and go" over last week.    When asked to repeat the story of what happened on arrival to the unit, wife speaks for the patient since he is slightly dyspnic. States this morning, went to small clinic, husband had a headache and slight fever. Clinic said to come in to the big hospital. Fever and pain in legs and head, started a few days after he got the covid vaccine. The fever came and went. Didn't measure the fever.  Also has some problems with Abdominal pain - doesn't know how to describe it. Feels like stomach ache. Stomach pain is getting better. Has since gone away since arriving to the hospital.  He denies any cough, denies chills, denies nausea or vomiting.   States he took some medications at home for constipation because he felt like he couldn't go. From the conversation it appears he does not take lactulose for HE, more for constipation.    ED workup included an Xray, CT C/A/P with multifocal lung lesions suspicious for multifocal pneumonia. Lactate of 16. Na of 124. Noted to be anemic and thrombocytopenic. UA cloudy, pyuric, w/protien >100.   Chest and abdominal pain resolved by the time pt was examined on the floor. Still tachypnic and tachycardic. Stated most bothersome was feeling anxious. Has anxiety at a baseline. Not complaining of any pain at the moment. Cannot describe chest pain in more detail, put his hand over the right side of his chest and presses on it but does not say if it hurt more when he would press on it, does not say it was reproducible. Not painful when he touches or presses on it now.    Per chart, patient recently re-established care after long-time from follow up during pandemic. At visits last month c/o gingival bleeding, fatiguem & found to have Hgb drop from 13 in 2018-> 9.7 on 3/2/21. Referred for EGD but cancelled due to anxiety.   I am the Infectious Diseases attending asked to see him for septic shock. He developed septic shock and respiratory failure requiring mechanical ventilation and 3 vasopressors. He has evidence of DAH, DIC, acute renal failure, progressive liver failure and he has Klebsiella pneumoniae bacteremia.
Pt. c/o "scratchy" throat and tightness in her chest, about 5 minutes after receiving the Japanese Encephalitis vaccine. BENADRYL PO 50mg given. Pt's B/P 100/60. States feeling better after 10 minutes of lying down (about 10 mins after taking med.).
Side effects of booster reaction; Experienced tiredness; Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Side effects of booster reaction), FATIGUE (Experienced tiredness) and VACCINATION SITE PAIN (Soreness at injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination.    Co-suspect products included non-company products DUPILUMAB (DUPIXENT) solution for injection for Atopic dermatitis and DUPILUMAB (DUPIXENT) solution for injection for Atopic dermatitis.    No Medical History information was reported.   On 12-Oct-2021, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 600 milligram. On 26-Oct-2021, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 300 milligram every two weeks. On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Dec-2021, the patient experienced FATIGUE (Experienced tiredness) and VACCINATION SITE PAIN (Soreness at injection site). On an unknown date, the patient experienced IMMUNISATION REACTION (Side effects of booster reaction). At the time of the report, IMMUNISATION REACTION (Side effects of booster reaction) outcome was unknown and FATIGUE (Experienced tiredness) and VACCINATION SITE PAIN (Soreness at injection site) had resolved.            The patient developed a non-serious event on 09Dec2021, she missed a dupixent shot due to having side effects of booster reaction. No concomitant medications were reported. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Additional Details: Patient received 3rd Covid shot about 3-5 minutes later patient lost consciousness and fell out of chair he was sitting in. Patient was face down laying on the ground when rph got to his. He regained consciousness when rph went over to check on patient. He states he felt it coming his vision started to go and it went black when he came back to rph was next to him. Rph had patient remain on the ground  and went on to check on patient. Paramedics arrived and check out patient
Inflamed area at injection site. Mild eryth, slight increased temp. 6cm x 6cm, NT.
Patient was seen in office for 4 month visit. Patient received 4 month vaccines, parents requested not to have Hep B administered. Patient should have received DTAP and IPV, however accidentally received Pediarix (DTAP, HepB, IPV) and IPV separately.
This spontaneous report as received from a physician refers to a 9 week-old patient of unknown gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies. On 01-MAY-2017, the patient was vaccinated with improperly stored dose of PEDVAXHIB (exact dose, dose number, route of administration were not reported; lot# M046140 with the expiration date of 27-SEP-2019) for prophylaxis. The administered dose of PEDVAXHIB underwent a temperature excursion of 48 Fahrenheit degrees for 16 hours. Digital data logger was not involved to capture the temperature excursions. There were no previous temperature excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012766.
The patient states with every flu vaccination since 2000 he will have URI symptoms (post nasal drip, nasal congestion, rhinnorhea, dry cough, watery eyes, rare body aches. No fever, sneezing, itchy eyes, N, V, D, severe body aches) starting 2-3 days after the vaccination and lasting 2-4 days. He treats the symptoms with OTC meds. He will be symptom free for about 4 weeks and then the cycle will repeat for 7-8 months. These sysmtoms do not result in the need to increase the use of this albuterol inhaler which he typically uses 2 times per week. In 2004 and 2006 when he did not have the influenza vaccination the pt did not experience these symptoms. Symptoms: Nasal Drainage, Watery eyes, Cough dry.
Flu shot on 10/10/2001. Went to the doctor's on the 14th for fever, vomiting, aches and pains. The doctor said that it's the virus, no Rx, but did blood work.
Painful, red, raised area at vaccine site. Lymphadenopathy to left axilla. Body aches, fatigue, dizziness.
High Fever 102.7; Hip Pain; Headache; Fatigue lasting through next day; No appetite.
With the first vaccination experienced itching the evening of the vaccination followed by extreme pain, redness and swelling of vaccination site the following morning, lasted a week or more. The day following the vaccination started extreme fatigue requiring leaving work early. This fluctuated for  a number of weeks requiring taking time off an additional day or two. Lasted approximately three weeks.
Developed  itching 1-2 days after vaccine given on 1/26/21.   Developed into severe hives  with large welts head to toe 1/29/21 and went to Urgent Care Clinic on 1/30/21. Given Prednisone 40mg daily  x 4 days Rx.  Hives worsened and given Prednisone 60mg daily x 5-6 days Rx  on 2/2/21.  Hives subsided after 2 1/2 weeks.
pt devel a dull, constant h/a w/in 24hr of vax;h/a is unrelieved by Advil;
Pox-like blisters began on right leg, then gradually spread. Rash on face, right leg, chest, arms, back. Rash/blisters minimal but spread rapidly after exposure to sun. Pox-like lesions are very itchy and painful simultaneously.
Covid-like symptoms; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid-like symptoms) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid-like symptoms). At the time of the report, COVID-19 (Covid-like symptoms) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Patient reported that he had 2 primary doses and then bivalent shot. He said that he had Covid-like symptoms after.  Treatment information was not reported.
information given by pt stated that she was 12yr old to receive vaccine however she was 11. the 1st dose had already been administered at a previous date. Second vaccine was given.
Pt received Proquad on 8.12.13 9AM. On Wednesday 8.14.13  swelling of left leg 50 cent size and cellulits about 4" across.
10 days after vaccination, developed temp 104, w/nausea & vomiting. Seen by MD fine rash on chest, stomach, & face also cold symptoms. Given Amocillin. Mom states throat & ears are neg. MD not sure it was due to immunization.
?Covid Arm?? my right upper arm became painful the eve of the injection, then developed a hot, reddish, hard, quite painful lesion on the front of the shoulder which after a few days started to hurt and itch. Today (8 days post injection) the lesion only itches but it is fairly intense and the affected area is swollen, as well.
Patient began having ringing in her ears and a headache the day after vaccination, continuing constantly through today
He is running a low grade temperature; This is a spontaneous report from a contactable consumer (reporter's husband). A male patient of an unspecified age received a dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that on an unspecified date, he was running a low grade temperature. The patient's wife (reporter) asked should she be alarmed about it or should she be worried, and Should she take him to the emergency room because he was running a low-grade temperature. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Received vaccine on left arm on 10/29/03. Over next 2 days, increased redness, warmth and pain. Seen on 10/31/03; started Levaquin for possible cellulitis versus local reaction. Worsened and spread; low grade fever. Admitted to hosptial on 11/01/2003 for ID treatment. The hospital discharge summary received on 3/23/04 states tenderness, adenopathy, sterile reaction.
I had chill and fever, and muscle and joint swelling and a headache the following morning, less than 24 hours later. On my armpit and lymphatic swelling, it had fluid buildup this was about 36 hour later, it lasted longer than anything else. 400mgs of ibuprofen every 4 or 6 hours for headaches and fever. I also took calcium lactic tablet for the chills. It took almost a week for the swelling to go away, I'm a massage therapist so I was self-treating, and removing the liquids from area.
Pfizer-bioNTech Covid-19 Vaccine   Sore arm Tired
No adverse effect; Patient received 3 doses/inadvertently administered additional dose; Patient received one dose each on 6/9/2015 and 7/2/2018; This spontaneous report was received from a licensed practical nurse regarding a 5 years and 2 months old patient. Information on pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 09-JUN-2015, 02-JUL-2018 and 06-AUG-2019, the patient was vaccinated with one dose each of varicella virus vaccine live (oka/merck)(VARIVAX) (dose, route, anatomical location, lot# and expiry date were not reported) for prophylaxis (extra dose administered (06-AUG-2019) and inappropriate schedule of product administration (02-JUL-2018)). No adverse effects were reported (no adverse event).
severe pain on and around injection site. fever up to 101.4. muscle aches, stomach cramps, headache
Rash; This case was reported by a consumer and described the occurrence of rash in a 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, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient filled out webform stated that she developed a rash after receiving the first Shingrix vaccine. No other details regarding rash were available. The reporter did not consent to follow-up.
shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath) 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 DYSPNOEA (shortness of breath). At the time of the report, DYSPNOEA (shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was unknown.   Reporter did not allow further contact
allerg rxn to vax-redness @ site, sore joints through the 1st day;it disappeared;the next day 4PM became very sick, weak legs, unable to work;rx DPH, pred, fluids;seen by MD;
On 5/12/05, she got three shots. On 5/13/05, she broke out with little bumps all over her body; head to torso were swelling and itching. Restless and hoarseness now on 5/24/05. Skin is peeling all over; hair falling out and has odor. 2 Benadryl bottles, Prednisolone and Keflex.
Patient with history of hives to Flu shot previously along with other allergies noted. Instructed to stay 30 mins. for monitoring. Around the 30 min. mark, patient reports tightness and discomfort around chest area and tongue numbness. Upon assessment, occipital lymph nodes were symmetrical. Bilateral feet kept elevated, water given. Vitals @4:17pm - BP 114/76, HR 118, Temp 37.3, O2 100%. Patient reports more chest discomfort and throat tightness. Epi pen 0.3mg administered at 4:19pm. Repeat vitals @4:22pm - BP 141/69, HR 123, O2 99%, Temp 37.3. Patient states some chest relief after Epi. Transported to ED for future monitoring and evaluation.
Starting the day after my body started ache in a variety of muscles top to bottom.  By that evening a awoke with body temp and fever.   My husband thought he was next to an oven, although I had the chills so bad I thought I could be going into shock,  Muscle pain head to toe.  Next day still a fever, no chills but lot of pain.  Could not get out of bed. That evening I was still  with body fever and aches, not until sometime  in the middle of the night did the fever break and after much ibupfren the pain and headache subsided.  Next day lethargic but most symptoms were gone.
Had regular period then had very late period. Went 67 days between periods, no pregnancies.
was given menA (lyophilized component) with saline diluent; was given menA (lyophilized component) with saline diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA582A, expiry date 31st August 2022) for prophylaxis.   On 30th November 2021, the patient received Menveo (intramuscular) .5 ml. On 30th November 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The reporter stated that the patient was given menA (lyophilized component) with saline diluent instead of with the correct menCYW component in the right deltoid, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.
15-month-old male inadvertently received expired Moderna (infant) for his 2nd dose at around 9:30 am on 9/6/2022. The Moderna vial expired 34 hours from the manufacturer's recommendation date (expired 9/4/2022).
chest pain, comes and goes; nasal congestion; pain on the left side of her body; This spontaneous case was reported by a patient and describes the occurrence of CHEST PAIN (chest pain, comes and goes), CHEST DISCOMFORT (congested) and PAIN (pain on the left side of her body) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     The patient's past medical history included Anxiety.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Aug-2021, the patient experienced CHEST PAIN (chest pain, comes and goes), CHEST DISCOMFORT (congested) and PAIN (pain on the left side of her body). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, CHEST PAIN (chest pain, comes and goes), CHEST DISCOMFORT (congested) and PAIN (pain on the left side of her body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment information was provided.