chrisvoncsefalvay/vaers-outcomes huggingface dataset:
an expired dose of ACTHIB was administered with no adverse event; Initial information received on 22-Dec-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a patient of an unknown demographics and it was reported that an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] was administered (expired product administered). Reporter stated that the diluent was expired on 26-Nov-2020 but the vaccine itself had an expiration of 26-Feb-2021. Reporter with question on whether vaccine needs repeating. On an unknown date, patient taking suspect vaccine (batch number and expiration date: unknown) at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.      Medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  This was an actual medication error case due to the event expired vaccine used (latency: unknown).  At the time of reporting, no adverse event was reported.  Disclaimer: 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 directive 2001/83/ec and module VI of the good Pharmacovigilance 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.  There will be no information about batch number was reported for the case.
Informatin has been received from a LPN concerning a patient between the age of 60 and 65 years who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot # 640981/1050L).  Subsequently the patient developed "severe local reactions at the injection site."  Follow up information received stated that the patient's entire upper arm became red and swollen.  Unspecified medical attention was sought.  The patient was treated with ice/diphenhydramine hydrochloride (BENADRYL).  The reporter noted that the patient recovered.  The reporter also mentioned 3 other patients between the ages of 60 and 65 years that had similar experiences following vaccination with a dose of pneumococcal vaccine 23 polyvalent (Lot # 640981/1050L) (WAES #'s: 0204USA02771, 0306USA02582, 0306USA02584).  Additional information is not expected.
24 hours after vaccination, pt started feel sweats on face and head for about 15 minutes followed by feeling 'hot' all over body lasting about hour to hour & a half.  Patient skipped dinner due to loss of appetite from feeling 'hot'.  She laid down and felt better. Patient slept ok and woke up feeling fine.
Provider summary "49-year-old female with past medical history significant for multiple sclerosis and tobacco abuse.  She presented to the emergency department on 06/21/2022 with a chief complaint of shortness of breath.  She had recently had COVID which initially had improved but then her symptoms came back.  On arrival she was diagnosed with pneumonia as well as possibly bronchitis.  She was started on antibiotics and steroids.  She did initially require supplemental oxygen but was weaned down to room air.  She had a CTA performed which was negative for pulmonary embolism but did show ground-glass opacities in the bilateral upper lobes which should be followed to resolution on an outpatient basis.  Notably, she has no formal diagnosis of chronic obstructive pulmonary disease so she should also get pulmonary function testing on discharge as well.  On day of discharge patient was in improved and stable condition.  She was ready to go home and was given strict return precautions to which she verbalized understanding.   Patient/daughter verbalized understanding and agreement to the above discharge plan. All questions were answered at time of discharge. "
>35 days since first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (>35 days since first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-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 PRODUCT DOSE OMISSION ISSUE (>35 days since first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (>35 days since first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 15-month-old female patient who received PEDIARIX. Co-suspect products included INFANRIX. On an unknown date, the patient received PEDIARIX at an unknown dose and INFANRIX at an unknown dose. On an unknown date, unknown after receiving PEDIARIX and INFANRIX, the patient experienced accidental overdose and irritability. On an unknown date, the outcome of the accidental overdose and irritability were unknown. It was unknown if the reporter considered the irritability to be related to PEDIARIX and INFANRIX. Additional details were reported as follows: The patient was given PEDIARIX and INFANRIX on the same day by mistake, which led to accidental overdose for DTP component. The patient was more cranky than usual. No further information was provided.
The pt experienced a local reaction characterized by redness and a 2 inch induration. This happened 3 days post vax.
Within 12 hours after receiving the first dose, I had a severe asthma attack, my heart raced for 2 days. My left breast swelled tremendously after only 4 hours of receiving the shot. My feet were numb for over a week and a half.  I had a sore throat, runny nose, severe fatigue, headache, body aches, chills, sneezing the next day that eventually subsided by day 2.
Adverse Events: Day of Injection: tingling throughout body and headache Day 1-5: headaches/migraines  Day 2-4: sore arm at injection site Day 8-11: developed a red blotch on injection site about 3" in diameter that was warm, itchy and swollen  Treatment for headache/migraines: Rizatriptan and Ibuprofen
mild case of shingles because she had been vaccinated/ Suspected vaccination failure; Shingles; Rash; This case was reported by a pharmacist via sales rep and described the occurrence of suspected vaccination failure in a elderly female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the vaccination failure, shingles and rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient was greater than 65 years of age, exact age was not known at time of report. The patient had shingles and when asked whether she had been vaccinated for shingles, patient reported yes but it was unclear if she had received Shingrix or Zostavax. The patient was experiencing rash mild symptoms. On 7th May 2021 (Friday), the patient presented for antiviral prescription at the pharmacy and had received an antiviral prescription that day. The reporter noted that efficacy of 100 percent would not be expected and perhaps the patient was experiencing a more mild case of shingles because she was vaccinated. The reporter consented to provide additional details at GSK safety follow up. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown.
pt recv vax & devel in inj site rxn characterized by redness & swelling w/pain radiating from site down the arm;pt has recv pneumococcal vax in the past;this is one of ten patients who exp above rxn p/vax;
Patient lost consciousness approximately 5 minutes post vaccination with Janssen COVID-19 vaccine. He was sitting in the observation area and fell out of his chair. Patient fell onto his side, and when he regained consciousness he said he didn't feel any pain or headache. Patient recovered consciousness in less than 1 minute and recovered completely in approximately 12 minutes. He laid on the floor for about 7 minutes, and then sat on the floor for another 5 minutes before feeling well enough to stand. Patient had a small patch of skin scraped off his right knee and right elbow, but declined bandaids. Patient did accept a small bottle of water and a bag of pretzels.
Pt received a VARIVAX on 10/29/12 & was dx'd with chicken pox on 11/21/12.
Rash on forearms started 05/06/2021, lasted 3 days, then went away, R eye got red & sore x3 days, then resolved; L eye, neck & face are now affected, pt attributes sx to 2nd COVID vaccine, has been using Sarna topical & oral Benadryl with good results
pt devel T102 few hrs p/vax given;was seen by PMD 1 wk before for OM;MD called re: fever & given APAP as ordered;pt in route to ER when pt arrested & taken to ER;hosp unable to revive pt
The day after the shot she developed fever for 2 days as high as 101.  She developed a pruritic burning rash to posterior right leg extending down the lateral lower leg.   She had fatigue and myalgias.    Diagnosed with shingles on 2/23. and informed to not receive the 2nd vaccine.   She presented to the Emergency room on 2/27 with fatigue, numbness right side of the face, no reports of shortness of breath or chest pain.   Ambulated in to ER.     After her work up she was discharged home - she present back to the ER within 30 minutes.  PTA arrival at the ER for the 2nd time - she complained of left neck and arm pain - then went unconscious.  She arrived to the ER in full arrest - pronounced deceased after resuscitation efforts were not effective
Resting heart rate over 90 bpm; Woke up at night; Felt like had drank several highly caffeinated beverages; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 07Apr2021 at 10:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, postpartum depression and seasonal allergies. Concomitant medications included loratadine (CLARITIN), fluoxetine (MANUFACTURER UNKNOWN) and levothyroxine (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknow if ongoing. The patient previously took sulfamethoxazole, trimethoprim, (BACTRIM) from an unknown date and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 10Apr2021 at 01:00, the patient experienced resting heart rate over 90 bpm (beats per minute), woke her up at night and would not decrease for several hours, it felt like she had drunk several highly caffeinated beverages. RHR (rapid heart rate) varied between 80 - 90 bpm (beats per minute) for 48 hours, then returned to normal after 72 hours. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event resting heart rate over 90 bpm was resolved on 13Apr2021 at 01:00 (after the duration of 72 hours), events woke up at night felt like had drank several highly caffeinated beverages were resolved on an unspecified date in Apr2021.   No follow-up attempts are possible. No further information is expected.
Myalgia, Arthralgia, Fever & Tachycardia Narrative:  has had HR problems since being diagnosed with  covid. was getting controlled until vaccine, which made HR  increase again.
Lower Back Issue; This case was reported by a pharmacist via call center representative and described the occurrence of back pain in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number HE2P5, expiry date 22nd February 2022) for prophylaxis.   On 3rd January 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced back pain. The patient was treated with prednisone. On an unknown date, the outcome of the back pain was unknown.   It was unknown if the reporter considered the back pain to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix and started with a Prednisone therapy for a lower back issue. The pharmacist was not sure of the patient´s clinical condition. He also clarified to the second line agent that the therapy consisted on 60 mg of Prednisone for 3 days, 40 mg for 3 days, 20 mg for 3 days and 10 mg for 3 days. The reporter consented to follow up.
fever chills body aches 20:00 4-12-22 to 05:00 fever to 100 F temporal.  05:00 feeling of extreme heat, nausea and explosion in head with black and yellow stars, awoke on bedroom floor with head under bed from last remembered position standing. Could not get up or even turn head without dry heaves. very weak difficulty talking low crawl to cell phone and front door called 911 transported to local hospital. diaphoretic on gurney with no covers extreme shaking and cold.
felt weak; dizzy; whole body hurt; diarrhea; terrible night; raging headache; This spontaneous case was reported by a physician and describes the occurrence of ASTHENIA (felt weak), DIZZINESS (dizzy), MYALGIA (whole body hurt), DIARRHOEA (diarrhea) and ADVERSE DRUG REACTION (terrible night) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 and Thyroidectomy. Concomitant products included VITAMINS NOS, VITAMIN D NOS and LEVOTHYROXINE for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced ASTHENIA (felt weak), DIZZINESS (dizzy), MYALGIA (whole body hurt), DIARRHOEA (diarrhea), ADVERSE DRUG REACTION (terrible night) and HEADACHE (raging headache). On 25-Mar-2021, ASTHENIA (felt weak), DIZZINESS (dizzy) and ADVERSE DRUG REACTION (terrible night) had resolved. At the time of the report, MYALGIA (whole body hurt), DIARRHOEA (diarrhea) and HEADACHE (raging headache) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications were not provided by reporter.   This case was linked to MOD-2021-057863 (Patient Link).
Itchiness ongoing; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness ongoing) and PAIN IN EXTREMITY (Arm pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced PRURITUS (Itchiness ongoing) and PAIN IN EXTREMITY (Arm pain). On 01-Mar-2021, PAIN IN EXTREMITY (Arm pain) had resolved. At the time of the report, PRURITUS (Itchiness ongoing) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that patient felt itchy off-and-on on a daily basis.  Concomitant product used was not provided by the reporter.  Treatment information was not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up information received  contains non-significant information
Pt recv vax on 12/12/98; on same day pt exp fever (104) & shivers; tx=Tylenol
Influenza vaccine given IM/LA at 10:30am. Patient was instructed to wait 20 minutes in waiting room. The injection site was red and swollen when checked at 10:50am. The patient was brought back to exam room and provider notified.
Got flu and pneumonia shot on Saturday AM. By 5:00 PM felt very bad and wife took him to hospital. Had temp. of 103 degrees F. Both shots were given in Rt. arm.
Record shows the patient had one dose of Moderna on April and 2 doses of Pfizer on May. Patient showed up in the clinic yesterday for booster shot of Pfizer - 4th MRNA vaccine.
This spontaneous report was received from a licensed practical nurse, referring to a 16 year old, female patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On unknown dates, the patient was vaccinated with the three dose series of GARDASIL (dose, route, lot # and expiration date were not reported). Then, on 14-JUL-2015, the patient was vaccinated with an additional dose of GARDASIL 9 by intramuscular route in the left arm (reported as LD), lot # K026247 (expiration date was not reported), because a company representative mistakenly told that it was the Centers for Disease Control and Prevention (CDC) recommendation. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information is not expected as all schedule follow up information has been received.
serious pain in my joints throughout my body/I have had since then constant and severe pain in the left shoulder; I had my booster on 15Oct2021; slight fever; chills; headache; This is a spontaneous report from a contactable consumer or other non healthcare professional (patient) reported for herself. A 72-year-old non pregnant female patient received third booster dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/lot number: Unknown), via an unspecified route of administration, administered in Arm Left on 15Oct2021 at 13:00 (at the age of: 72-year-old) as dose 3 (booster), single for covid-19 immunisation. Medical history included adrenal gland cancer, hypertension and allergy to Penicillin from an unknown date and unknown if ongoing. Concomitant medications included losartan (LOSARTAN) and atenolol (ATENOLOL) received within 2 weeks of vaccination. The patient did not receive any other vaccine within 4 weeks prior to covid vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6199), via an unspecified route of administration, administered in Arm Left on an unspecified date and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN7534), via an unspecified route of administration, administered in Arm Left on an unspecified date, both as a single dose for covid-19 immunisation. She had her booster on 15Oct2021. On 15Oct2021, the night of the booster shot, patient had a normal minor side effects with slight fever, chills, headache by two days later (18Oct2021) at 12:00, she began to develop serious pain in her joints throughout her body. It was very bad for about a week, but she has had since then constant and severe pain in the left shoulder, and it has not gone away. The patient did not receive any treatment for the events. The clinical outcome of the events was not recovered/not resolved at the time of this report.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Extreme Tiredness x2 days Very Nauseous x2 days Sinus Headache
PATIENT REPORTS THAT AFTER HER FIRST COVID 19 VACCINATION SHE HAD INCREASED MALIZE (COULD NOT GET UP OUT OF BED), SEVERE BODY ACHES, SORE ARM AT THE INJECTION SITE BUT NO REDNESS REPORTED.  SHE DID NOT SEEK ANY MEDICAL TREATMENT AND ONLY TOOK OTC MEDICATIONS AT HOME.  SHE STATES THAT S/S RESOLVED IN 5 DAYS WITHOUT INTERVENTION
Tightness in chest; Difficulty breathing; Flu like symptoms; 2 hours of sleep last night; Joint pain; Nausea; Muscle aches/ Achiness; headache; Very tired/ Fatigued; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Tightness in chest), DYSPNOEA (Difficulty breathing), INFLUENZA LIKE ILLNESS (Flu like symptoms), INSOMNIA (2 hours of sleep last night) and ARTHRALGIA (Joint pain) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD and Diabetes. Concomitant products included UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (ANORO ELLIPTA) and FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) for COPD, GABAPENTIN, LEVOTHYROXINE, INSULIN, APIXABAN (ELIQUIS), VARENICLINE TARTRATE (CHANTIX), MIRABEGRON (MYRBETRIQ), MONTELUKAST, ALBUTEROL [SALBUTAMOL], ALBUTEROL [SALBUTAMOL] and QUETIAPINE FUMARATE (SEROQUEL) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced CHEST DISCOMFORT (Tightness in chest) and DYSPNOEA (Difficulty breathing). 11-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), INSOMNIA (2 hours of sleep last night), ARTHRALGIA (Joint pain), NAUSEA (Nausea), MYALGIA (Muscle aches/ Achiness), HEADACHE (headache) and FATIGUE (Very tired/ Fatigued). The patient was treated with OXYGEN for Dyspnoea, at a dose of breathing; PARACETAMOL (TYLENOL) for Headache, at a dose of 1 dosage form and OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) for Headache, at a dose of 10/325mg. On 11-Mar-2021, CHEST DISCOMFORT (Tightness in chest) and DYSPNOEA (Difficulty breathing) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), ARTHRALGIA (Joint pain), NAUSEA (Nausea), MYALGIA (Muscle aches/ Achiness), HEADACHE (headache) and FATIGUE (Very tired/ Fatigued) had not resolved and INSOMNIA (2 hours of sleep last night) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time. The events were consistent with increased risk of complications associated with elderly age of patient. Company assessed the events to be unlikely related to company product.
A 19 month old child received 5 vaccines on 8/9/01 in the morning. In the early afternoon, mom called me to report that the baby's breathing was irregular every few breaths, after a hard crying session. Baby fell asleep again and continued the pattern. Mother was concerned that the child was having a reaction to vaccines that were given that morning.
Information has been received from a physician concerning an 11 year old patient who on 04-SEP-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # and route no reported) instead of VARIVAX (Merck). The patient did not suffer adverse effects. Additional information has been requested.