chrisvoncsefalvay/vaers-outcomes huggingface dataset:
INCORRECT PRODUCT STORAGE; THE JANSSEN COVID 19 VACCINE WAS REFROZEN AND ADMINISTERED TO PATIENT; This spontaneous report received from a health care professional concerned a 29 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, and expiry: 20-MAR-2022) dose was not reported, administered on 07-JUL-2021 for prophylactic vaccination. Age at time of vaccination 29 years old. No concomitant medications were reported. On 07-JUL-2021, the patient experienced the janssen covid 19 vaccine was refrozen and administered to patient. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the the janssen covid 19 vaccine was refrozen and administered to patient and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220537341, 20220537683, 20220538146, 20220541180, 20220538238, 20220538297, 20220538379, 20220538428, 20220537548, 20220538480, 20220538573, 20220538693, 20220538890, 20220540420, 20220540435, 20220540474, 20220540524, 20220540536, 20220540611, 20220540642, 20220540688, 20220540765, 20220540814, 20220540816, 20220540853, 20220541085, 20220541180, 20220541401, 20220541506, 20220537507, 20220538480, 20220540324 and 20220538758.
2 days after the second dose of my Pfizer Covid-19 Vaccine, I have developed continual ringing in both ears which is still continuing at the same volume.
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, concomitant therapies and past drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # N009773 expiration date: 20-SEP-2018 (strength, dose, route and anatomical location were not reported) for prophylaxis. No adverse effects were reported. It was stated by the reporter that the incorrect product storage had a time frame of 2 hours between  6° F and 14° F (6.3°F); and the call was given because of a data logger. Previous temperature excursions had not occurred. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1709USA008263:
Pt recv vax on 1/27/99; on 1/29/99 pt exp red & nodule at rt arm vax site; tx=Benadryl
COVID-19 case. I had fever for 3 days, tachycardia for 1 day, and a cough for 4 weeks. The symptoms were moderate. I took TYLENOL.
This spontaneous report was received from a nurse practitioner refers to a patient of unknown age and gender. No pertinent medical history was reported. On 21-NOV-2014, the patient was inadvertently vaccinated with expired dose of PNEUMOVAX 23 10 VIALS of 1 (lot # J010654 and expiration date was 17-OCT-2014) dose 0.5 ml, intramuscular. Concomitant therapy was not reported. No adverse effects reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Pt received his 5th Anthrax on 8/5/00 and noted redness and swelling to below the elbow in the right arm with minimal pain.
Diarrhea; Sore arm; a big red circle on the injection site; A spontaneous report was received from a consumer concerning a female patient who received Modern's COVID-19 vaccine (mRNA-1273) and experienced diarrhea, sore arm and a big red circle on the injection site.    The patient's medical history was not provided. No relevant concomitant medications were reported.      On 19 JAN 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 029620) for prophylaxis of COVID-19 infection.    On 28 JAN 2021, The patient experienced diarrhea, sore arm and a big red circle on the injection site. No Laboratory details provided.    No treatment information was provided.     Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events diarrhea, sore arm and a big red circle on the injection site was Unknown.
Patient states her whole forearm has been hurt since the vaccination. She has some difficulty moving her arm, bruise at injection site.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 16-NOV-2018, the patient was vaccinated with improperly stored VAQTA (lot # R013859, expiration date 14-JUN-2019) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Developed hive at site of MMRV about 5 minutes post administration. No other symptoms noted. BENADRYL 7.5 ml given PO. Observation done. Mother instructed on S/Sxs to watch for and dosing of BENADRYL.
itching burning rash in whole face; itching burning rash in whole face; is only tingling/today is the first day can say it is only tingling; A week after booster patient developed itching in face; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (A week after booster patient developed itching in face), PARAESTHESIA (is only tingling/today is the first day can say it is only tingling), BURNING SENSATION (itching burning rash in whole face) and RASH (itching burning rash in whole face) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 935904, 001B21A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, the patient experienced PRURITUS (A week after booster patient developed itching in face). On 27-Dec-2021, the patient experienced PARAESTHESIA (is only tingling/today is the first day can say it is only tingling). On an unknown date, the patient experienced BURNING SENSATION (itching burning rash in whole face) and RASH (itching burning rash in whole face). At the time of the report, PRURITUS (A week after booster patient developed itching in face), BURNING SENSATION (itching burning rash in whole face) and RASH (itching burning rash in whole face) had resolved and PARAESTHESIA (is only tingling/today is the first day can say it is only tingling) had not resolved.            No concomitant medication was given.  Patient treatment included cold in the face and anithisitamines. Reportedly, booster hurt 3-times as bad as the other too.
AE: pt reported chest pain and tingling/ numbness of lips approximately 30 minutes post vaccination Tx: EMS eval and vitals Outcome: pt refused further treatment and transport
Start tasting the medication (Unspecified Medication); I felt was I take the medication for 2 days; Pain; felt like a little swelling; Soreness of arm/the pain in shoulder going down the arm/arm was in pain; Arm muscles is still achy; Dryness in my mouth for 2 days; Tenderness; swelling in upper lip; My left lip was swollen and my toe was swollen; Pain in my shoulder going down the arm and like it start shaking; Pain in my shoulder going down the arm and like it start shaking; I start having anxiety because of the fear I guess; lot of anxiety started kicking around I guess because of the pain of the chest; I start having anxiety because of the fear I guess; lot of anxiety started kicking around I guess because of the pain of the chest; I could not sleep; Tingling; This is a spontaneous report from a contactable consumer (patient). A 61-year-old patient of unspecified gender received unknown dose number of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date on Monday (at the age of 61-year-old) as single dose for COVID-19 immunization and received Cortisone injection one week prior to the COVID-19 vaccine. Medical history included preexisting health condition (unspecified) and concomitant medications of the patient included some unspecified medication. When patient received the vaccination, patient informed them about preexisting conditions and with the preexisting condition and had cortisone shot prior a week. On an unspecified date on the very first day of vaccination patient start tasting the medication (unspecified), patient take the medication for 2 days. On the second day of vaccination, patient experienced the pain, the soreness of the arm, felt like a little swelling, dryness in mouth for 2 days, on Wednesday [third day] patient was feeling a little better but still had little soreness of the arm and little dryness and then I went to bed. On Thursday patient was not feeling bad, was feeling okay, a little dryness and felt a little tenderness and soreness of the arm, not much and then woke up at about 4 am in the morning [Friday] and had like swelling in toe and swelling in upper lip and the pain in shoulder going down the arm/arm was in pain/ arm muscles was still achy and like it start shaking and then patient had anxiety because of the fear and pain of the chest. This morning when patient woke up, patient could not sleep and went to sleep again and when woke up around 10 started to feel a little better, the swelling was gone, and the pain of the arms was gone but it still had a little tingling. So patient was just calling to find out are those things normal. Outcome of the event swelling, dry mouth, pain in arm, lip swelling, toe swelling were resolved and for other events were unknown.  No follow-up attempts are possible. Information about lot/batch number has been requested.
twitching on right arm/ left side of face; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (twitching on right arm/ left side of face) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced MUSCLE TWITCHING (twitching on right arm/ left side of face). On 19-Mar-2021, MUSCLE TWITCHING (twitching on right arm/ left side of face) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants products were reported. No treatment information was provided.
Received Flu vaccine and HPV vaccine #3 to (L) deltoid on 3/24/14. Developed cellulitis (L) deltoid 3/25->3/26 treated with KEFLEX w/ BENADRYL.
ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN ACUTE PULMONARY EMBOLISM
Urinating a lot; Constant urge to urinate 3-4 times an hour; Urge to urinate got worst as the day went by; Unable to sleep; This spontaneous case was reported by a consumer and describes the occurrence of POLYURIA (Urinating a lot), POLLAKIURIA (Constant urge to urinate 3-4 times an hour), MICTURITION URGENCY (Urge to urinate got worst as the day went by) and INSOMNIA (Unable to sleep) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (Improvement with weight loss) since 2013 and Hypothyroidism since 2011. Concomitant products included HCTZ for Hypertension, LEVOTHYROXINE for Thyroid disorder.    On 02-Aug-2021 at 7:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced POLYURIA (Urinating a lot), POLLAKIURIA (Constant urge to urinate 3-4 times an hour), MICTURITION URGENCY (Urge to urinate got worst as the day went by) and INSOMNIA (Unable to sleep). At the time of the report, POLYURIA (Urinating a lot), POLLAKIURIA (Constant urge to urinate 3-4 times an hour), MICTURITION URGENCY (Urge to urinate got worst as the day went by) and INSOMNIA (Unable to sleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had zero spasms and zero pain while urinating and the urge to urinate went from a rating of 10/10 to 1/10. Patient reported that the patient had stopped taking HCTZ to help with the issue. The patient was going to the bathroom about 12 times in an hour. It was either a normal amount or just a few drops. The patient was unable to sleep on a night as the patient had to go to the bathroom all night. No treatment medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Aug-2021: Follow-up received : updated patient demographics, added  patient medical history,concomitant medications, added event of unable to sleep
Pt woke the next morning with edema of the face & lips - mother notified doctor for BENADRYL dosage recommendation. BENADRYL per MOC was 50 mg q 4-6 hrs.
Pt complaints of itching and hives. Liquid Benadryl give(25mg) Pt symptoms resolved
SUSPECTED VACCINATION FAILURE; COVID-19 INFECTION; PAIN IN KNEES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 204A21A expiry: Unknown) dose was not reported, frequency one total, administered left arm on 07-MAY-2021 for prophylactic vaccination. It was unknown if the patient had any adverse event with (dose number in series 1). The patient received booster of covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, expiry: unknown) dose was not reported, frequency one total, administered left arm on 03-NOV-2021 for prophylactic vaccination (Dose number in series 2).  No concomitant medications were reported. On 06-JAN-2022, the patient experienced diarrhea, sore throat, headaches, muscle pain, pain in legs and knees. Laboratory data included: COVID-19 antigen test (NR: not provided) positive (coded as covid-19 infection and suspected vaccination failure).   The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in knees and covid-19 infection and the outcome of suspected vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint:90000211250; Sender's Comments: V0:20220112320-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Severe Vertigo when I woke up in the morning of 12/26/2021, after administration of Pfizer COVID-19 booster on 12/24/2021.
Stiffness in joints, knees, ankles, wrists swelling especially right wrist. Back swelling and insomnia. Migratory swelling, redness. Pt also experience loss of balance. Annual follow up on 03/08/04: "Pt has not recovered from adverse events.  Pain and swelling both knees, right wrist surgery, pain migratory swelling and redness, fingers, toes, ankles.  Insomnia left hip pain, trocurtric bursitis, stomach ulcers, skin rashes, migraines.  My whole life has been turned upside down.  I'm going through a medical board to be discharged from my work I need to be compensated for my pain and suffering. 4/19/03: I just had an episode here is the report. I sent 5 envelopes of documented medical problems stemming from the shot.
Strange, itchy rash that continued to grow worse for several weeks, fatigue,  flu-like symptoms causing missed schooling, anxiety and panic attacks intensified.
Pericarditis; myocarditis, cardiogenic shock. Supported via ECMO and heart pumps for 1.5 weeks
patient received her second dose of moderna 7 days early. This was noticed when patient's husband came to receive his second dose and he was told he was too early. He explained his wife had received her 2nd dose 3 weeks later from the first dose.
pounding headache that has lasted for 5 days , swollen glands  in back of head and right arm pit - 3 days,  pain  and swelling of several surgical scarring from a medical procedure in 2019 on right side -for 2/12 days,  chills through entire body on and off for about 6 hours- 24hours,  with extreme numbness in fingers and feet - to the point they turned  white lasting for about 45 min and then another 5 min , congestion - about 6 hours  and increase in blood pressure
Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patient were vaccinated with improperly stored GARDASIL 9 (lot # L014415, expiration date 25-JUL-2017, dose and route were not reported). Concomitant drug was not reported. No adverse effect was reported. This is one of the several reports from the same reporter. Additional information has been requested.
SICK; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick. This report was non-serious. This case, from the same reporter is linked to 20210817417 and 20210815700.
Pain up the back of neck; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Pain up the back of neck) and HEADACHE (Headache) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.    Concurrent medical conditions included Tinnitus. Concomitant products included ALPRAZOLAM (XANAX) for Tinnitus.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced NECK PAIN (Pain up the back of neck) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NECK PAIN (Pain up the back of neck) and HEADACHE (Headache) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
3/16  Fever 100.8, Motrin stopped the climb and reduced the fever, dizziness, heart rate 100 , bp elevated, upper arm at injection site red and swollen. 3/17  Fever 100, arm hurts more. Redness expanded to about 3 inches around.
Swelling, redness, hot to touch and fever to 102F and restless. Went to ER and was given Claritin and Advil. Ice to leg. Swelling continued but decrease in fever. Saw MD and he gave Advil for fever.
Pain in my back started 4 days after receiving the shingles vaccine, and then a rash emerged 2 days later. I've gone to a doctor who confirms that I have shingles, one week after receiving the shingles vaccine.
c/o feet and toes tingling 15 minutes after vaccine.  States tingling had happen before but cannot remember when or what he was doing. P66 strong & regular BP126/88.  EMS evaluated student.  Student went to nurse office to wait for his mother to take him home.
Information has been received from a consumer concerning a 12 year old male with Penicillin allergy and a history of chickenpox who on 11-March-2008 was vaccinated with VARIVAX (Oka/Merck). Concomitant therapy included MENACTRA and diphtheria toxoid + pertussis vaccine + tetanus toxoid (unspecified) tetanus toxoid. The patient was previously vaccinated on 06-Mar-1997 with VARIVAX (Oka/Merck). The patient met his grandmother who is immunocompromised and has lymphoma on 14-Mar-2008 and she developed nerve pain and shingles on 18-March-2008. The experiences of the 12 year old male are documented in WAES#0803USA05043. Additional information has been requested.
Severe pain to lower left leg without injury hx. Went to doctor on 3/17/21 and was examined and doppler to left leg showing no blockage.  Dr prescribed nsaid as needed for pain and monitor. Monitored and pain continued until approx 4/9 and noticed swelling starting and some redness to skin slightly warm. Returned to dr on 4/13 and was placed on antibiotics. On 4/14 noticed slight shortness of breath on exertion and on 4/15 shortness of breath worsened and some irregular heartrate. I  went to hospital. Bloodwork, EKG, Chest xray and CT showed multiple pulmonary embolisms and several DVTs in left leg. Admitted to hospital and placed on Heparin drip and monitored for three days. Released from hospital on 4/19 on Eliquis and advised to follow up with personal physician and report severe breathing problems or CP.
11/11/2022 I had gone into the hospital for a colonoscopy, routine. During the procedure, my heart went into Atrial Flutter. I had several ekg?s confirmed my Atrial Flutter and I was put on Eliquis.  I will be going in for a Cardio Version on 1/11/22.
Bilat RVL & LVL areas where injections administered, red, warm to touch and swollen.
Pt woke up during the night w/raised rash, size of the hand all over body except on chest & face. Rash was like whelps. Dr said he thought it was a reaction from vax & started pt on Benadryl. Pt took it for 24 hrs & rash had gone by evening
Patient reported itching of posterior tongue, under further observation and over 10 minutes, worsening itching to tongue and swelling sensation, noted by PA starting to clear throat and having more forceful swallowing. Patient reported difficulty swallowing. Administered epinephrine 0.3 mg IM and diphenhydramine 50 mg IM (IV line could not be started). Patient mild hypertension but other vitals stable. EMS called and patient transported to ED for further evaluation.
A dose was wasted due to a dull needle. A new vaccine was subsequently administered to the patient.