chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from the Pregnancy Registry for GARDASIL from a License Practical Nurse (L.P.N.) concerning a 14 year old female patient who on 29-MAY-2007 was vaccinated IM with a dose of GaARDASIL lot #654535/0960F and found to be pregnant on 06-JUN-2007.  The patient came into the office for a physical because of complaints of an irregular period and was given the injection as a routine immunization.  The laboratory test complete metabolic profile (CMP), human chorionic gonadotropin test (HCG), insulin levels, lipid profile, thyroid panel and complete blood count with differential (CBC with diff) were done.  Results are not available.  The outcome was unknown.  Additional information has been requested. oN 06-JUN-2008, follow up information received from the licensed practical nurse reported that the patient had a full term healthy and normal female by vaginal delivery on 17-OCT-2007. No further information is availble.
The first day, my left arm seized up and became so tense I could hardly use it. Within the next couple days, that feeling spread throughout my entire body, and I could barely stand. It gradually subsided over the course of the past 5 months, buy I still have felt an abnormal amount or muscle tension, tightness, nerve sensitivity, and anxiety.
She developed significant lower extremity edema within 24 hours of COVID vaccination #3.  She also had lymphadenopathy in her groin, and this was considered reactive from immunizaton and the primary cause of edema, as all other factors were excluded including DVT, heart and liver disease
Vomiting, Diarrhea, Ache, Nausea From initial information received on 10/Dec/2003 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a 31-year-old male patient received a dose of Fluzone SV 2003-2004 USP, lot number U1123AA, administered intra-muscularly in the deltoid and a PPD test ( lot number, manufacturer, route and site of adminstration not reported) on 08/Dec/2003 at noon.  The patient had also received a HEPATTIS A vaccine (lot number, manufacturer, route and site of administration not reported) within four weeks of receiving the products given on 08/Dec/2003.  On 09/Dec/2003 at 4:00 am, the patient developed nausea, vomiting, diarrhea and complained of body aches.  The patient's recovery status is currently unknown.
The patient came into the pharmacy today stating she had been in bed the past two days with little strength. Her left arm was red about 2 inches below the injection site and she stated it was sore to the touch. She said she was feeling a lot better now than she had the last few days.
6 months infant received QUADRACEL instead of PENTACEL with no reported adverse event; Initial information received on 22-Jul-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involves a 6 months old patient of unknown gender received Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) Vaccine [Quadracel] instead of Pentacel with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 22-Jul-2022, the patient received an unknown dose of suspect Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) Vaccine (Suspension for injection) (lot number; expiry date; strength; frequency) not reported via unknown route in unknown administration site for prophylactic vaccination.  On 22-Jul-2022, 6 months infant received Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) Vaccine [Quadracel] instead of Pentacel  with no reported adverse event (latency: same day).  It was unknown if there were lab data/results available.  Action taken: Not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
Diagnosed with Costochondritis the fourth after coming into the emergency room believing my ribs had collapsed the day before, went to ER second time () due to severity of pain and received same diagnosis, had multiple doctors confirm my reaction was almost definitely due to my body responding to vaccines. Also visited a gynecologist for lesions that my gynecologist  believed were a reaction to my vaccines.
Patient came to our pharmacy and stated that after receiving ZOSTAVAX, she's experiencing stabbing pain from elbows and radiating down to wrists. The pain happens on both arms but more on the right.
(R) shoulder ?  in varicella immunization site. TX ibuprofen and warm compress.
Swelling in his left armpit area; Soreness in the muscle area/ Tenderness in the muscle; Little lethargic; Pink; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (Swelling in his left armpit area), MYALGIA (Soreness in the muscle area/ Tenderness in the muscle), LETHARGY (Little lethargic) and VACCINATION SITE ERYTHEMA (Pink) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history recorded.).    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced AXILLARY PAIN (Swelling in his left armpit area), MYALGIA (Soreness in the muscle area/ Tenderness in the muscle), LETHARGY (Little lethargic) and VACCINATION SITE ERYTHEMA (Pink). At the time of the report, AXILLARY PAIN (Swelling in his left armpit area), MYALGIA (Soreness in the muscle area/ Tenderness in the muscle), LETHARGY (Little lethargic) and VACCINATION SITE ERYTHEMA (Pink) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This initial spontaneous report was received from a physician referring to a 9 week-old male infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 08-SEP-2015, the patient was vaccinated with a dose of improperly stored oral, ROTATEQ (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved.  This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Was monitored for 15 min afterwards. Left facility, tingling on roof of mouth, swollen tongue, shortness of breath. Stopped at nearest emergency room on way home.
At night of the vaccination day my daughter woke up screaming as if on fire and we could not calm her down. It happened 4 times that night. Day later she got sick with fever and cough. I called her pediatrician and was dismissed as a normal reaction and probably she was getting sick already.
There were no signs or symptoms of any adverse reactions, from administering the injection.  Patient was given the PCV23, instead of PCV7.
Approximately 30 minutes after vaccine, patient started to have Rigors without fever, teeth chattering, Body Dystonia and shaking. ER X 2- Hypokalemia, SOB - Dystonic reaction Transient numbness.
very bad reaction; Nauseous; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (very bad reaction) and NAUSEA (Nauseous) in a 75-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In September 2023, the patient experienced IMMUNISATION REACTION (very bad reaction) and NAUSEA (Nauseous). The patient was treated with DIMENHYDRINATE (DRAMAMINE) for Nauseous, at an unspecified dose and frequency. At the time of the report, IMMUNISATION REACTION (very bad reaction) and NAUSEA (Nauseous) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Patient had a very bad reaction. Patient was sick all day after taking the Spikevax. Patient asked her doctor if patient could take the Spikevax if patient was getting a shot on knee. Patient was also on an antibiotic. Patient reported that this was worse than what had in the past and what patient expected.   This case was linked to US-MODERNATX, INC.-MOD-2021-022622 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 25-Sep-2023: Significant information received contains event and Reference ID added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-022622:Spikevax 2023-2024 product case
Information has been received from a health professional concerning an approximately 11 year old patient who on 25-SEP-1997 was vaccinated with a dose of VARIVAX (Merck) (lot#, route and site of administration not reported). On approximately 06-MAY-2008 the patient developed few lesions. At the time of reporting, the patient's outcome was unknown. This is one of several reports from the same source. No further information is available.
Narrative: Headache, Myalgia, Nausea, Vomiting & Tachycardia. Reports worse headache of his life hour after dose. Severe Nausea and Vomiting. Could not get out of bed. Racing heart. Severe Fatigue and brain fog. Sx resolved on Friday 9/16/22. Still has moderate brain fog and mild fatigue.
"Negligible side effects" after all the doses, except for her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION ("Negligible side effects" after all the doses, except for her arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis and Hypertension.   On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 VACCINATION COMPLICATION ("Negligible side effects" after all the doses, except for her arm). At the time of the report, VACCINATION COMPLICATION ("Negligible side effects" after all the doses, except for her arm) outcome was unknown.            patient took an immunosuppressant drug for a long time but stopped after the pandemic started.  Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-325511, MOD-2021-325478 (Patient Link).
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 30-SEP-2014 the patient was vaccinated with ZOSTAVAX, subcutaneous, (lot # J07211 exp date: 20-SEP-2014) dose and frequency not provided. No adverse effects reported. No further information provided. The outcome of Expired vaccine used was unknown. The reporter considered Expired vaccine used to be not related to ZOSTAVAX. Additional information has been requested.
large red "circle" at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number 5JX9Z, expiry date 5th November 2021) for prophylaxis.   On 20th January 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 22nd January 2020, 2 days after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was recovering/resolving.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were reported as follows: The patient received a dose of Shingrix on the left deltoid. The patient developed a large red circle at her injection site after vaccination. The reporter consented to follow up.
Patient has a red, swollen , itchy and hot area at the injection site.  This has remained present for over a week.
1/3/2011 received TST, TDAP, TWINRIX, MMR, Varicella. Pt. stated & observed to have macular rash in inner elbow region with some scratch marks she stated she had an allergy to the vaccinations returned 1/6/2011 for interpretation of TST . Around each area of injection were 1mm vesicles.
Area of injection became red, swollen, tender and warm to touch. Was approx 5cm in diameter and firm to touch. The site was also itchy. The patient took Benadryl and applied ice to the spot. All symptoms resolved in 3 days.
swollen lymph node on armpit; This case was reported by a consumer via call center representative and described the occurrence of axillary lymph nodes enlarged 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 axillary lymph nodes enlarged. On an unknown date, the outcome of the axillary lymph nodes enlarged was unknown.   It was unknown if the reporter considered the axillary lymph nodes enlarged to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's mother. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and experienced swollen lymph node on armpit. The reporter did not give a consent to follow-up.
Child (6 mo) adm expired dose of ROTATEQ on 12-20-10 per order from Dr. - parent to be called for redose of child - 4 wks from previous dose on or after 1-20-11.
mom states that pt broke out w/ a rash, large red whelps & itch all over; states took DPH & the itch was relieved; red areas present on 14APR93 no itching;
This spontaneous case reported by a consumer, describes the occurrence of headaches (intense like brain was on fire) and myalgia (body aches) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Jun 9, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced headaches (intense like brain was on fire) and myalgia (body aches). At the time of the report, headaches (intense like brain was on fire) and myalgia (body aches) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided.
I went to bed just fine on the night of the vaccine. Woke up two hours later with extreme shortness of breath, sweating and hot flashes. Symptoms eventually disappeared within 48 hours. But they returned on June 20th, though more mildly. Mainly whenever I puff my cigarette, I start feeling a lack of breath -- not being able to  breath deeply and fully. If I keep puffing, I eventually start having hot flashes and chest pain. It's very bizarre, because I've been puffing 10+ years with no problems.
This spontaneous report was received from a physician regarding a patient of unknown age and gender. The patient's relevant medical history, drug history and concomitant medication information was unknown. On an unknown date, the patient was vaccinated with GARDASIL 9 lot/batch# 36301 with an expiry date in December 2017(dose, frequency and route were unknown). The administered vaccine underwent a temperature excursion and had been exposed to a temperature of 32.1 degree Fahrenheit for 7 hours. The patient did not experience any adverse events. It was unknown if any relevant tests were done. Lot number 36301 is an invalid lot number for GARDASIL 9. This is one of the several reports received from the same reporter. Additional information has been requested.
fainted; This spontaneous report as received from a pharmacist via a company representative refers to a young female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date ,reported as several years ago, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, dose, route of administration, lot# and expiration date were not reported) for prophylaxis.  On an unknown date, the patient fainted. The outcome of the event was unknown, also reported as the patient was "fine".  The relatedness between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.   Upon internal review, the event of faint was considered to be medically significant.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Feb2021 at 15:00 as dose 1, single (Lot number: EL9263), in right arm, on 21Mar2021 at 15:00 as dose 2, single (Lot number: EN6208), in right arm and on 17Dec2021 at 16:00 as dose 3 (booster), single (Lot number: FJ1611) at the age of 68 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional Information: No Other medication in 2weeks, Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date was 07Jul2022, Treatment stop date was 05Jul2022, Indication: Treatment of COVID-19. Adverse event: Muscle tremors and cramps have n feet, Adverse event start date: 10Jul2022, Adverse event start time: 12:00 AM, If patient recovered: Recovering, If treatment ae: No, Other medical history: None.
doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Apr-2021 at 10:26 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 10:26 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 63.44 for dose administered on 3-Apr-2021   No concomitant medications were reported.  Batch number 014M20A underwent temperature excursion on 3-Apr-2021 with temperature range of 34 Degree Fahrenheit from 09:00 AM. These vials were moved to fridge on 30-Mar-2021 and beyond use date for the vials was reported as 29-Apr-2021. Product moved to clinic on 03-Apr-2021 Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. No treatment medications were reported
Patient wanted to get 2 vaccines on the same arm on 8/19.  He was due for 2nd Shingrix vaccine and also was due for an annual flu shot.  The two injection sites were separated by about 1 inch apart.  The patient came to the pharmacy complaining of sore arm that has been lasting for longer than 2 weeks.  Per patient, he cannot lift his right arm freely due to severe pain.  Morning seems to be worse than the evening.  We are suspecting that getting 2 vaccines on the same arm probably burdened his immunity.  The patient has never had unusual reactions to any vaccines.  The patient has been taking Tylenol for pain with a minimal pain relief.  The patient would seek medical help soon, but her wife is sick, so he will wait until her wife gets better first.
Patient admitted to hospital after developed rash suspicious for Steven Johnson syndrome, this rash began 4 days after he received the Hepatitis B shot, his second dose of the series. 06/27/08 Reviewed hospital medical records of 4/16-4/18/2008 FINAL DX: no d/c summary available.  H&P states Stevens-JOhnson syndrome secondary to hepatitis B vaccine. records reveal patient experienced a worsening urticarial rash since day after vaccination.  Had been seen in ER on 4/13 & dx w/allergic reaction to hepatitis vaccine, cellulitis & tinea pedis.  Sent home on antibiotics & antifungal meds.   Bilateral LE & hands swollen. Seen by dermatologist, dx w/erythema multiforme & received steroid injection.  Condition worsened.  Developed oral lesions 2 days prior to admission & had decreased oral intake.  Seen by PCP, sent to ER & admitted.  Skin lesions were now clear blisters & more violaceous involving entire body w/ulcers on feet that had ruptured.  Tx w/IV steroids & IVF.