chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Drug Allergies: Prevnar, Nitrofurantoin; This is a spontaneous report received from a contactable reporter(s) (Physician) for a sponsored program (005570).  A 90 year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (Batch/Lot number: unknown) as dose number unknown, single for immunisation; nitrofurantoin (NITROFURANTOIN) (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "Drug Allergies: Prevnar, Nitrofurantoin". The action taken for nitrofurantoin was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
About 4 hours after immunization, had leg swelling and hives at (R) thigh at site of Hib vaccine associated with prolonged crying.
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 71 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (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: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 12Feb2022, outcome "unknown" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (12Feb2022) positive. Therapeutic measures were taken as a result of suspected Covid-19. Additional information: Tested positive for Covid on 12Feb2022 and subsequently received Paxlovid. She received both initial doses of the Pfizer BioNTech Covid-19 vaccine as well as the booster prior. Confirmed all three were the Pfizer BioNTech Covid-19 vaccine. She is scheduled to receive her second booster today at Pharmacy, is there any recommended interval between Paxlovid treatment and receiving the second booster shot. The lot number for bnt162b2 was not provided and will be requested during follow up.
Body aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Myalgia, at an unspecified dose and frequency. At the time of the report, MYALGIA (Body aches) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant product use was provided.   This case was linked to MOD-2021-419483, MOD-2021-419500 (Patient Link).
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 09-FEB-2012, the patient was administered with a dose of VARIVAX (Merck) (Lot # 0869AA, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports from the same source. Additional information has been requested.
No adverse effect; one patient was administered improperly stored Varivax; This spontaneous report was received from an administrator and refers to a 15-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 18-SEP-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot # S004091 and expiration date 11-FEB-2019 (exact dose and route of administration were not reported) for prophylaxis. Concomitant therapies included properly stored sterile diluent. No adverse effects were reported. The temperature was from 6°F to 14°F (14F) for 420 hours and from 15°F to 46°F (34F) for 106 hours. Previous temperature excursion was from 6°F to 14°F (14F) for 200 hours and from 15°F to 46°F (34.268) for 18 hours. Digital data logger was involved.; Sender's Comments:  US-009507513-1911USA000877:
This spontaneous report was received from a registered nurse concerning her sister, a female patient of unknown age. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, strength, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The register nurse reported that on an unknown date, the patient had redness and a lump at injection after receiving ZOSTAVAX. Nurse stated that the redness and lump lasted for a week (also reported the outcome as unknown). At the time of the report the outcome was unknown. Additional information has been requested.
Burning upon administration-pins and needles feeling from injection site all the way down the arm to the finger tips
Mother reported daughter fell in bathroom in the middle of the night- said she couldn't see  then sight came back.  Then again Mother checked on daughter later on and daughter was unresponsive when mom was tapping her in the face-she was just looking at her mom but not seeing or hearing her -like a black out-- couldnt be woken up easily- and when she did wake she couldn't see.  But since those 2 episodes daughter's sight is back but she feels nauseous and has an upset stomach.
Covid 19 / tested positive; This case was reported by a consumer via call center representative and described the occurrence of coronavirus infection in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of feeling abnormal (1st dose received on an unknown date, refer case US2020AMR080136).   On 2nd May 2020, the patient received the 2nd dose of Shingrix. On 7th May 2020, 5 days after receiving Shingrix, the patient experienced coronavirus infection (serious criteria GSK medically significant). On an unknown date, the outcome of the coronavirus infection was unknown.   It was unknown if the reporter considered the coronavirus infection to be related to Shingrix.  Additional information was provided as follows: The reporter was patient's wife. The patient did not have any symptoms. The reporter said that in her city they were offering Covid 19 testing. The patient and her wife were tested for Covid 19, the patient tested positive and his wife tested negative The reporter said, she thought it may be that the Shingrix vaccine interfered with the results.  Caller said husband did not currently have a doctor that he sees. The reporter did not consent to follow up.
After the shot, I only had a slightly sore arm. Several hours later, after I had fallen asleep, I awoke to sudden onset face swelling on my right side, severe and sudden sneezing and stuffiness, and a severe asthma attack. We called 911, and in the meantime I took 2 Benadryl and used my rescue inhaler. My breathing was assessed as diminished by the paramedics, and I was taken to the hospital. I was given oxygen and prednisone, and monitored.  About 2 hours later I was released.
Patient described redness and tenderness around left orbital area starting a few hours after administration. Tenderness and swelling progressively worsened and moved to lower left eye. Patient claimed area was tender when pressure was applied.  Area around left orbital appeared erythematous and swollen.
Initial information received on 07-Aug-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked with 2018SA220766, 2018SA220773, 2018SA220774 and 2018SA218532 (same reporter). This case involves three patients of an unknown demographics who received a dose of DAPTACEL (lot number, expiry date, dose, route and site of administration were not reported) instead of QUADRACEL (lot number and expiry date were not reported) on an unknown date. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered. It was not reported if the patients experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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. Documents held by sender: none.
Allergy; Pain; 2 years after all started again/Allergy; 2 years after all started again/pain; itching on arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of allergy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced allergy (Verbatim: Allergy), pain (Verbatim: Pain), allergy (Verbatim: 2 years after all started again/Allergy), pain (Verbatim: 2 years after all started again/pain) and itchy upper limbs (Verbatim: itching on arm).  The patient was treated with aciclovir (Acyclovir) and probiotics (nos) (Probiotic). The outcome of the allergy, pain and itchy upper limbs were resolved and the outcome of the allergy was not resolved and the outcome of the pain was not reported.   It was unknown if the reporter considered the allergy, pain, allergy, pain and itchy upper limbs to be related to Shingles vaccine.     It was unknown if the company considered the allergy, pain, allergy, pain and itchy upper limbs to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-Sep-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she was vaccinated with Shingles and it took him/her a while to get rid of it. The patient used used aloe vera, Acyclovir, nothing calmed it down. The patient took everything for allergies and pain and it calmed down for a few hours, until he/she discovered Daily probiotic, they ordered it and luckily it was remedy for about 2 years. The patient reported that now it had started again. The last night before reporting the patient had a lot of itching on his/her arm. The patient took it for the allergy and it calmed down basically. The follow up could not be possible as no contact details were available.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about September 2008, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route and site of administration were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries. In approximately 2008, after and despite being inoculated with the ZOSTAVAX, the patient was diagnosed with shingles and/or other zoster-related injuries and suffered serious physical, emotional and economic damages as a result of patient's injuries. On or about October 2008, the patient was treated for shingles. The reporter considered adverse events to be related to ZOSTAVAX. As a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care - for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
Papular vesicular pruritic rash began 1 week after receiving Varivax booster.
Throbbing pain in arm. Later I started to have heart palpitations  and aching all over my body. Around 7am the next day I ran a low grade fever and felt flushed also both hands  felt like I had severe arthritis.  I ending up sleeping most of the day on January 6th. Today January 7th I feel much better but still have pain in my left arm.
Patient's right post lateral arm swelled up post his elbow. He went to the emergency room where he received antibiotic treatment.
Pneumovax administered in right arm on 11/5 in the morning.  By that evening, patient's right arm from her shoulder and one half way to her elbow was swollen.  She felt so much pain there that she couldn't lift her arm.  She had a fever of 102 degrees. On 11/6, her fever was 101.8 degrees.  Her arm still hurt, but less.  She spent the day in bed. Today, 11/7, she is still recovering, but feels a little better.  Though her arm is still tender, it is functional.  She is afebrile today.
Poor quality vaccine administered; Patients received the Moderna COVID 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna COVID 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In April 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna COVID 19 vaccine after temperature excursion). On 25-Apr-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna COVID 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that there had been temperature excursions with the freezer that was happened for weeks since April 2022. Storage condition at the time of the excursion were frozen.  It was reported that Lot numbers: 065K21A and Lot numbers 045L21A had undergone temperature excursion and maximum and minimum temperatures reached were 30 Fahrenheit Degrees and minus 18.9 Fahrenheit Degrees respectively.  It was reported that the vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute and date the vials moved from freezer to refrigerator was unknown, they were now stored in frozen condition and no vaccine state change was observed.  No treatment medications were reported.
Numbness reported in bilateral, posterior upper arms where immunizations (Right Arm- Hep A, Tdap;  Left Arm- Influenza TIV, Menactra) were given. Numbess reported to begin about 1 day after vaccines were given.
Red, raised, warm rash about 2? below injection site; headache, muscle aches, sore arm, fatigue
Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a  currently 60 year old female patient (pt). No information was provided regarding concomitant medications, concurrent conditions or medical history.   On unknown date, zoster vaccine live (ZOSTAVAX) was prescribed by health care provider and in or about 2010, the pt was vaccinated by a pharmacist with zoster vaccine live (ZOSTAVAX) for routine long-term prevention of shingles and zoster-related conditions (strength, dosage schedule, route, lot number and expiration date were not provided).  On an unspecified date, the pt developed herpes zoster. On unspecified date, the pt was treated health care center for herpes zoster t.  The outcome of the event was not provided. The reporter considered herpes zoster result from  zoster vaccine live (ZOSTAVAX) use.  Additional information has been requested.
Pt after moving to waiting area after COVID vaccine and felt dizzy and passed out over into chair next to her. Pt had not eaten after I had not eaten after I spoke to her 6am (vaccine was 115pm)
Tested positive for Covid after the 1st dose; Dry cough; little sore left arm; Chills; Felt little tired; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Jan-2021 and was forwarded to Moderna on 28-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid after the 1st dose), COUGH (Dry cough), PAIN IN EXTREMITY (little sore left arm), CHILLS (Chills) and FATIGUE (Felt little tired) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. o41120A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced COUGH (Dry cough), PAIN IN EXTREMITY (little sore left arm), CHILLS (Chills) and FATIGUE (Felt little tired). On 26-Jan-2021, the patient experienced COVID-19 (Tested positive for Covid after the 1st dose). The patient was treated with PARACETAMOL (TYLENOL) ongoing from 25-Jan-2021 at a dose of 1 dosage form. On 27-Jan-2021, COUGH (Dry cough), PAIN IN EXTREMITY (little sore left arm), CHILLS (Chills) and FATIGUE (Felt little tired) had resolved. At the time of the report, COVID-19 (Tested positive for Covid after the 1st dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, SARS-CoV-2 test positive: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The second dose of mRNA-1273 is scheduled on 15 FEB 2021.
Initial information received from a health care professional on 16 Jul 2010: This patient received the MENVEO (batch number 100005, expiry date unknown), intramuscular on 14 Jul 2010. The patient not received the lyophilized conjugate component of MENVEO. No other adverse event was reported. The outcome of the event was not reported.
Patient developed febrile illness on 6/2/18. Persisted for 5 days and then resolved. No other symptoms until 6/7/18 when developed ataxia.
Patient received the Pfizer Monovalent vaccine instead of the Pfizer Bivalent Vaccine.  No adverse side effect just med error.  NP informed and patient was notified of the error.
Fine papular rash on thighs and face treated with Elocon three times a day.
booster; her skin is red, tender and warm in the arm area in where she had the shot; her skin is red, tender and warm in the arm area in where she had the shot; her skin is red, tender and warm in the arm area in where she had the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administered in arm, administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "booster"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE WARMTH (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 2021, outcome "unknown" and all described as "her skin is red, tender and warm in the arm area in where she had the shot".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Narrative:  1/11- Moderna dose 1 2/8- Moderna dose 2 7/16- presented to emergency facility, primary diagnosis COVID19; worsening dyspnea and altered mental status; pt is resident of ALF; given zithromax, decadron, cardizem, remdesivir; admitted to ICU on high flow NC 7/26- spouse is also ill and is in the ICU; spouse is very SOB 7/27- patient passed away
Redness, rash, warm to the touch, soreness all the way to the armpit. Patient was told to put a cold compress on the site as well as take Benadryl.
High Fever for days, loss of speech, loss of ability to recognize things as before, difficulty walking and balancing, screaming fits for about 3 months, weight loss, repetitive movements with hands, hitting head on things, unconsolable. She still has not fully recovered her speech and still is not performing at age level since vaccination.
Looks like patient received shot at 1:40pm on 10/19/2018. Later that night 8:30pm-ish patient stated she experienced diarrhea, vomiting, fever, wheezing, chills, arm swelling, erythema, rash on localized area. She went to ER on 10/20/18 Saturday 6:30am and was discharged around 9-10am. Pt didn't complain about immunization adverse reactions.
This spontaneous report as received from a registered pharmacist refers to a patient of unknown age and gender who on unknown date in 2015 was inadvertently vaccinated with an expired dose of ZOSTAVAX (lot # J012679, expiration date 21-JAN-2015) intramuscular (dose and site of administration were not reported). No adverse effects reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Patient complaining of severe headache, chills, body aches, sore throat, running nose, cough, nausea and vomiting and watery, itchy, burning eyes
Arm very sore . hurt to lift up about 6 hours post vaccination and continues today (11/20/23) minor improvement but affected sleep. hurts to raise arm upwards still
1150AM  Swelling throat feels she cant breathe, she refuses Epi pen says it may anxiety 1203 pm Given  Benadryl 25mg po vitals stable 1213 Given Benadryl 25mg  po, rest in supine position. 1230  feels more relaxed swelling in throat still a little scratchy. 1300 scratchy/swelling resolved. 1320  Sat up on exam table feels fine. ER precautions given, Exited in stable condition.
Received 1st H1N1 @ school 0830 AM, at 0915 c/o being cold, dizzy, tired, pale. No fever.
Became pale and clammy. Felt "light-headed." He asked for water. Lied down on mat, feet elevated. Feeling of light-headedness passed after 5 minutes (1848). Right deltoid site benign. Monitoring changed to 30 minutes. Sat up at 1852. Color better, no longer clammy. Given water and juice. Tolerated well. Feeling better @1858. Will wait 30 minutes at next vaccination, educated & states understanding.
Mom noted pt was wakeful night of 18JUN; AM of 19JUN lt thigh red & tender; Seen: induration & erythema 6x8cm distal to inject site;