chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 01-MAY-2014, the patient was inoculated with the ZOSTAVAX vaccine at a drug store 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 01-JUN-2014, the patient was treated at a physician office for the onset of a vesicular rash, which was diagnosed as herpes zoster. 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.
insomnia; a little achy; a little nauseous; A spontaneous report  was received from a healthcare professional concerning a 64-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events a little nauseous, a little achy, insomnia.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 10 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  on an unknown date, she experienced events include a little nauseous, a little achy, insomnia.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not applicable.   The outcome of event(s), a little nauseous, a little achy,insomnia was unknown.
Lightheadedness, Nausea, Headache, Body Pains, Sore arm
Nueve dias después de la aplicación, molestia y enrojecimiento en el area de inyección.
This case was reported by a consumer via call center representative and described the occurrence of abdominal crampy pains in a 13-year-old male patient who received BOOSTRIX. Concomitant products included Anastrozole. On 1st February 2018, the patient received BOOSTRIX (intramuscular). On 5th February 2018, 4 days after receiving BOOSTRIX, the patient experienced abdominal crampy pains. In February 2018, the patient experienced nausea. On an unknown date, the outcome of the abdominal pains was recovered/resolved and the outcome of the nausea was unknown. It was unknown if the reporter considered the abdominal crampy pains to be related to BOOSTRIX. The reporter considered the nausea to be possibly related to BOOSTRIX. Additional details were provided as follows: This case was reported by the patient's mother. Concomitant medications also included Omnitel. At 17:30, the patient received Tdap vaccination on the right am. She believed that it was GSK brand BOOSTRIX. The patient experienced abdominal cramping that comes and goes. About every 15 minutes he experienced very painful cramps. In February 2018, less than a month after receiving BOOSTRIX, the patient experienced nausea. The patient had not been out and about for the previous 2 weeks before the reporting date, so she did not believe it was an infection that was causing these symptoms.
No symptoms until 9 days later, when I noticed a raised, red, burning/itching rash start on my leg at the incision site from my hip surgery a couple months ago. It spread around the whole surgery area, around all the incision scars and on the front around the back up the buttocks. While I was trying to identify a cause or what it was, I noticed also on my left arm where the vaccine injection site was, and around the whole deltoid muscle had also started this rash. So I googled to see if the cause might be from the vaccine and it seems it might be so I thought it prudent to report it, especially since I also had this rash around where I recently had surgery. I treated it with hydrocortisone cream and an oral antihistamine.  It lasted about 30 hours but has started to subside now.
This case was reported by a healthcare professional and described the occurrence of injection site redness in a 4-year-old female subject who was vaccinated with KINRIX (GlaxoSmithKline), VARIVAX (non-gsk). Previous and/or concurrent vaccination included MMR vaccine (non-gsk); Merck; unknown; unknown given on 12 September 2009. On 12 September 2009 the subject received 1st dose of KINRIX (.5 cc, unknown, left thigh) and 2nd dose of VARIVAX (Non-GSK) (unknown). On 15 April 2010, 7 months after vaccination with KINRIX and VARIVAX (Non-GSK), the subject experienced injection site redness, warm to touch, injection site induration approximately 7 by 10 centimeters and injection site inflammation. Both KINRIX and VARIVAX sites were inflamed and red. The subject was treated with antibiotics and BENADRYL. At the time of reporting the outcome of the experienced injection site redness, warm to touch, injection site induration and injection site inflammation was unspecified. The healthcare professional reported two other cases, see case A0855353A and A0855505A.
The morning after the injection, I woke up with a horrible rash on the bottom part of both legs (knees down).  The rash got worse throughout the day and started on my chest that evening.  By the end of the night (the day after injection), my tongue and airway appeared to be swollen and I had trouble taking full breaths.  I started taking 2 Benadryl every 4 hours. I took that dosage for the next 2 days.  The breathing got better, but the rash is still present (as of day 5 after injection).
3 doses of PROQUAD were administered to patients at unknown times following a temperature excursion; No additional adverse events or any product quality complaints were reported in this case; This spontaneous report was received from a vaccine coordinator/healthcare professional, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, at a dose of 0.5 milliliter (ml) injected, once (vaccination scheme, anatomical site of injection, and route of administration were not reported; lot number T025506, expiration date: 23-JAN-2022) as prophylaxis, following a temperature excursion (product storage error). No additional adverse events or any product quality complaints were reported.  On an unknown date, the vaccine underwent a temperature excursion of 5.68 degrees Fahrenheit (F) for 5 minutes. There was a previous temperature excursion of 18F for 1 hour and 30 minutes, as recorded by a data logger.
Rcd. Varicella & MMR on 8/16, on 8/26 developed rash - papules on trunk - front & back & thighs. Runny nose. Temp 99. Rechecked 8/29 & had 5 vesicles & cont. with multiple papules but most fading.
This spontaneous report was received from a Licensed Practical Nurse refers to a multiple unspecified patients of an unknown age and gender. The patients' relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patients were vaccinated with improperly stored (at a temperature of 9C for 24 hours) GARDASIL 9, lot # L024993 (expiry date: 17-OCT-2017) and lot# L044475 (expiry date: 12-MAY-2017) (dosage not reported). No adverse effects reported. No data logger. No Product Quality Complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Patient had a Tdap vaccine in her left deltoid and the influenza vaccine in her right deltoid at 9:38 AM on 10-2-12. About 6:00 PM on 10-2-12 patient's right arm itched & bumps were forming. She has 15 red, raised, fluid filled pimples on her right arm. She had about 24 hours of temp., getting up to 102 degrees F & body aches. The difference between the vaccines is the Tdap came in a prefilled syringe & I attached a needle. The influenza vaccine was drawn out of a multi dose vial with a latex stopper. I did not change the needle.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Sep-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 16-Sep-2021, PAIN IN EXTREMITY (Sore arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications reported by reporter No treatment medications provided by the reporter  Patient stated that sore arm lasted little over a day   This case was linked to MOD-2021-355719 (Patient Link).
Received a booster shot from an expired lot; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a booster shot from an expired lot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a booster shot from an expired lot). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Received a booster shot from an expired lot) had resolved. Not Provided          No concomitant medications were reported. No treatment medications were reported.
CHIEF COMPLAINT:   AMS @ 0700. Per EMS she started yelling at her neighbors. Per EMS, strong urine smell. Pt alert to self.   HISTORY OF PRESENT ILLNESS:     Patient is a 68-year-old female who is brought in by EMS after neighbor called stating she was yelling in her apartment and sounded confused since 7:00 this morning.  When fire arrived, per EMS, they noted the patient was laying on the ground, uncertain if she had fallen.  They placed her back in bed and when EMS arrived, they noted that she was sitting in bed with number of TRAC pads, full of foul-smelling urine present.  Patient is alert and oriented x1.  Her progressive blood sugar was in the 150s, mildly hypoxic, per fire, at 89% on room air and was placed on several liters by nasal cannula.  Patient otherwise had unremarkable vital signs.  Patient states that she is in pain but is unable to elaborate where she is experiencing pain.  History is limited due to her mental status.  She denies headache, chest pain, shortness of breath, nausea or vomiting or abdominal pain.
4 full days after receiving vaccine, red rash started on arm of injection, slightly below injection sight.  Red area continued to grow for 24+ hours.  Red area hot to touch.  Left arm very sore.
hard red itchy spot about the size of 2 quarters at injection site.  It went away in ~ 5 days.  No medical treatment provided.
Upper arm was pink from injection site down to elbow.  Patient stated it was sore and warm to the touch.  Advised patient to take benadryl and APAP, and to use cool compresses.
Pt was presented to the office on 11/29/2001 4 weeks after receiving MMR, with rash for 2 days. Rash was maculopapular, confluent. Fever for 2 days.
sudden onset of severe muscle pain and inflammation.  Went to doctor in May and was eventually diagnosed in July with Rheumatoid Arthritis of which I had no symptoms prior to the vaccine.
9x11cm redness, warmth, induration, itchy, sore lt arm;
pt recv vax 21JUL97 & 30JUL97 & exp a fever to 101;31JUL97 pt devel a mild macular rash on abd, chest, & back w/no vesicles;pt rectal temp during on office visit on 31JUL97 98.5;
Pt developed a 2cm x 1cm purple, raised, tender lesion over the injection site that has not gone away since the injection.
19-month old male dependent with h/o facial and upper lip angioedema, as well as periorbital angioedema within 15 minutes after receipt of 12-month shots: MMR #1, Varicella #1, PCV #4 and Hep A #1 - not #2 as doc on DD 2766C). Similar symp 3 wks later not a/w vaccines. Ref to Allergist who recommended f/u with Allergy once family PCS's prior to toddler's 18-month shots. Clinic notifies of patient. Mother wants to know how proceed with child's vaccines.
The day after I experienced pain and swelling under my left armpit. They have subsided a week later but some minor swelling still exists.
Patient received FLUMIST on 10.12.11 at a school based immunization clinic. On 10.18.11, mother reports that on 10.13.11, patient developed an itchy rash to face, arms, back & legs. No rash noted on trunk. On 10.17.11 patient went to physician and received SOLU-MEDROL injection. Follow up telephone call to mother who states rash started to resolve after SOLU-MEDROL & it is now gone.
Small, fluid filled blisters on arms, chest, abdomen, waist, behind ears, and smaller blisters on inner thighs. Patient states blisters resemble "Chicken Pox".
Pounding headache that lasted for 30 hours.  Sensitivity to  light. Chills around 1am
Patient received 1st dose Janssen 02/18/2022 Lot # 211D21A Patient received a 2nd Dose Pfizer 02/23/2022 Lot # 33025BD
received the second dose / shingles appeared; shingles / on her upper right thigh and wrapped around her back; nerve damage from shingles; severe pain / burning pain; nerve pain; dizziness; nausea; pins and needles feeling; wake her up in the middle of the night; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 17th December 2020, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix and unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, nerve damage, pain, nerve pain, dizziness, nausea, pins and needles and wakefulness. On an unknown date, the outcome of the vaccination failure, shingles, nerve damage, pain, nerve pain, dizziness, nausea, pins and needles and wakefulness were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, nerve damage, pain, nerve pain, dizziness, nausea, pins and needles and wakefulness to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, in the evening of vaccination the patient experienced dizziness and nausea. In the following day, the patient had some sever pain. The patient had shingles on right upper thigh and wrapped around back. The patient was woke up in the middle of the night with nerve pain sometimes. The patient still had nerve damage from shingles with the pins and needles feeling but there is no more burning pain anymore and the shingles outbreak has resolved. The patient received Tylenol, Ibuprofen and pain killer from the physician as a treatment medication. The reporter consented to follo wup.
While driving home after receiving the vaccines, her BP was raising for about 30 minutes. That night she had a severe headache and BP was high still. Severe headache was happening during the day and in the evening. Pupil of eyes become very small but today (09/10/2018) was better. She describes the headaches as like whenever she takes nitroglycerin. She mentions that she had a low grade fever yesterday and today.
As a prerequisite to receiving a flu shot, I received a PCV13 (pneumococcal conjugate vaccine) yesterday afternoon. Apart from the usual swelling and associated pain, I have maintained a fever of 100 degrees since last night, and aspirin and ibuprofen have not brought it down.
The patient has not experienced any  adverse events, the patient received  a dose of vaccine that was not diluted to the proper amount.
Weeks after first dose had a blood test that showed elevated WBC and ALT, on repeat WBC improve to normal, ALT and AST increased 5 times normal, presently without symptoms of Hepatitis but complains of generalized swelling or fluid retention.
Injection site 2" red and sl. warm to touch, day after injection given. Complained of itching.
death J18.9 - Pneumonia, unspecified organism E87.1 - Hypo-osmolality and hyponatremia
Simple febrile seizure  6/13/08 Reviewed ER medical records of 6/1/2008. FINAL DX: febrile seizure; viral syndrome; dehydration Records reveal patient experienced fever, tiredness, irritability, diarrhea, decreased appetite & decreased urine output, cough, congestion.  Awoke from nap & became stiff, gasping respirations & unresponsive.  Tx w/IVF
30 hours after receiving second dose, experienced high pitched sound in ears. Erroneously thought it was an amber alert on my smart phone. Soon became a constant swooshing sound. Hearing was then impaired so that I could not make out what my wife was saying to me standing right in front of her without hearing aids in my ears. With my hearing aids inserted, I can hear her speaking now but hearing ability has clearly been diminished.
Pt developed periorbital swelling, urticaria to face and neck, tightness in throat and wheezing. Given albuterol by nebulizer X 1; IM Solu-Medrol.
pt recv vax 16OCT96 & exp various mild aches & pains;pains located in back, sides, arms, legs, shoulder (arthritis);states pain is achy, stiff, & spasm-like;calls then little pains;also c/o h/a;pt instructed to see MD;
died yesterday; This is a spontaneous report received from Medical Information from a contactable other health professional. A 57-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 17Mar2021, at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient died in Mar2021 (reported as "yesterday"). The outcome of the event was fatal. The cause of death was not reported. It was unknown if an autopsy was performed.  Information on the lot/batch number has been requested.; Sender's Comments: Event unknown cause of death is assessed as related until sufficient information is available to confirm an unrelated cause of death. 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.; Reported Cause(s) of Death: died yesterday
sick as a dog/ they were both sick for 2 days; This is a spontaneous report from a contactable consumer (patient father). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The caller states that his granddaughter was a Nurse practitioner and she had both of her covid vaccine shots, and his daughter she also got the vaccine, they were both sick as a dog/ they were both sick for 2 days on an unspecified date. The outcome of the event was reported as unknown.
Left after began to itch slightly lower than injection site after 11 days from vaccination. Within 20 min became red rash. Rash remained for 3 days. By third day was red outline only.   Rash reappeared 2 days after second dose. Less itchy however larger and redder than first time.
bot of his legs swelling; Water retention; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (bot of his legs swelling) and FLUID RETENTION (Water retention) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included AFib. Concurrent medical conditions included DVT (Edema or swelling in legs due yo DVT, worsened with time and experience continued after second dose) since 20-Mar-2021. Concomitant products included APIXABAN (ELIQUIS) for AFib, LISINOPRIL, METOPROLOL and HYDRALAZINE for Blood pressure management.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced PERIPHERAL SWELLING (bot of his legs swelling) and FLUID RETENTION (Water retention). The patient was treated with FUROSEMIDE ongoing since an unknown date for Water retention, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (bot of his legs swelling) and FLUID RETENTION (Water retention) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 23-May-2021: Follow-up received: Added historical conditions.Updated patient demographics, indications of concomitant medications used and event outcome.
blood coming out of her right nostril; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (blood coming out of her right nostril) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced EPISTAXIS (blood coming out of her right nostril). On 23-Jan-2021, EPISTAXIS (blood coming out of her right nostril) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported  No treatment information was provided   This case was linked to MOD-2021-026419 (Patient Link).
On 28 March 2021, Patient received his Janssen Covid-19 vaccine. The vaccine was administered in the LEFT shoulder, lateral deltoid muscle. Time of vaccine administration (12:01pm), the needle separated from the syringe. This caused the patient to only receive half of the 0.5mL vaccine volume.  The injection site was then covered with a band aid, and the patient was informed to wait 15 minutes before leaving the clinic. He was informed to return to clinic in one hour as shot administration had stopped. CDC guidelines were reverenced regarding incomplete Covid-19 vaccine administration. It was decided since the true volume administered could not be verified, the patient would receive another complete 0.5mL Janssen vaccine. At 2:01pm, patient received 0.5mL of Janssen Covid-19 vaccine in the RIGHT shoulder, lateral deltoid muscle. He then waited another 15 minutes following the vaccine administration. He did not report any adverse reaction to the vaccine and was cleared to leave the clinic. He was informed of common side effects of the vaccine. No other adverse event took place. The event to report is that patient received approximately 0.75mL of the Janssen vaccine as the first dose was incomplete. No other adverse event took place aside from the mishap administering the first vaccine.  He did not experience any health concerns from receiving the vaccine.