chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness at injection point; headache; general joint pain; stiffness; cognitive cloudiness; not feeling 100% normal; This is a spontaneous report from a contactable consumer, the patient. A adult male patient of unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route in the left arm on 18Mar2021 at 14:00 as a single dose for COVID-19 immunisation. Medical history included heart murmur, medullary sponge kidney and spontaneous pneumothorax from an unknown date.  Concomitant medications included atorvastatin (LIPITOR)for unknown indication from unknown date. The patient not had any allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 18Mar2021 at 14:15, the patient experienced soreness at injection point (left arm), mild headache, general joint pain and stiffness which was more on left hand side, some cognitive cloudiness and general health of not feeling 100% normal. Therapeutic measures were taken as a result of adverse event and included treatment with  Advil. The clinical outcome of vaccination site pain, headache, general joint pain, stiffness, cognitive cloudiness and feeling abnormal was not recovered.   Information about lot number cannot be obtained. No further information expected.
took covid-19 booster and felt under the weather and took covid-19 booster and felt achy; took covid-19 booster and felt under the weather and took covid-19 booster and felt achy; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (took covid-19 booster and felt under the weather and took covid-19 booster and felt achy) and PAIN (took covid-19 booster and felt under the weather and took covid-19 booster and felt achy) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 25-Aug-2021, the patient experienced MALAISE (took covid-19 booster and felt under the weather and took covid-19 booster and felt achy) and PAIN (took covid-19 booster and felt under the weather and took covid-19 booster and felt achy). At the time of the report, MALAISE (took covid-19 booster and felt under the weather and took covid-19 booster and felt achy) and PAIN (took covid-19 booster and felt under the weather and took covid-19 booster and felt achy) outcome was unknown.            No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-624135, MOD-2021-624127.
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 95 and received care in the ED on 3/9/21 for a gout flare. No notes documenting his death on 3/25/21 are in his chart records. Comorbidities include advanced age, afib, mechanical mitral valve replacement, chronic renal failure, CAD, HTN.
COVID vaccine breakthrough case. Pfizer 5/5/21 EW 0165, 5/26/21 EW0191, 12/8/21 330308D and 5/4/22 FJ4991
Had shots and got shingles / suspected vaccination failure; Shingles in back; No sleep; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure 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 vaccination failure (Verbatim: Had shots and got shingles / suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles in  back) and insomnia (Verbatim: No sleep). The patient was treated with lidocaine (Lignocaine). The outcome of the vaccination failure was unknown and the outcome of the shingles and insomnia were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and insomnia to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and insomnia to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-MAR-2023 This case was reported by the patient via interactive digital media. The reporter stated that, he/she had the shots and got the shingles in his/her back.  It finally left with lignocaine cream and patches.  It had sucked all the life out of his/her, and he/she had no slept.  He/She had praise god and asked if it was gone. Since, it was a case, therefore, ligocaine was coded conservatively instead of lonnocaine considering it to be a typo error. This case was considered as suspected vaccination failure as details regarding, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible, as no contact, details were available.
2 days after started having diarrhea, 3 days after started getting "violently ill" with vomiting and diarrhea. Also had headache, body aches, nausea, fever. These were all the same symptoms she had when she had covid in 6/2020.
ringing in her ears; flu-like symptoms; tired; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing in her ears), INFLUENZA LIKE ILLNESS (flu-like symptoms) and FATIGUE (tired) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced TINNITUS (ringing in her ears), INFLUENZA LIKE ILLNESS (flu-like symptoms) and FATIGUE (tired). On 12-Mar-2021, INFLUENZA LIKE ILLNESS (flu-like symptoms) had resolved. At the time of the report, TINNITUS (ringing in her ears) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Heart rate: 117 bpm (Inconclusive) 117 bpm for 24 Hours. On 10-Mar-2021, Oxygen saturation: 93 % (Low) 93%.         For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  No concomitant medications were reported. No treatment medications were reported.  Action taken with mRNA-1273 in response to the event was not applicable.
Case was hospitalized for COvid 7 months after completion of primary Covid vaccine series.  * Pneumonia due to COVID-19 virus Assessment & Plan Presented with several days of weakness and shortness of breath. Completed Moderna vaccine series in early March. Symptoms started 10/8, mostly with global weakness and dyspnea. Mildly hypoxic on arrival but CTA was unremarkable aside from mild bibasilar atelectasis. Now on room air.  Treated with dexamethasone and remdesivir for several days but these were stopped after hypoxia resolved since he was ready for discharge aside from logistical issues. Date of symptom onset: 10/8 Date of positive test: 10/10
Information has been received on 06-JUN-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In October 2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2016, the patient was treated by a nurse practitioner for a persistent and severe vesicular rash, which was diagnosed as a herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient has suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
p/vax pt work up for GE + occult blood in stools; severe abd cramps; #1 barium enema-intussusception suspected, believed to be reduced w/ diagnostic enema;hosp; 2 additional BE's confirm no further intuss;disch
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On and unknown date, the patient was vaccinated with an improperly stored dose of VAQTA lot # L045713; expiration date 14-JAN-2016 and M-M-R II lot # L001336; expiration date 13-JAN-2017 (dose and route of administration were not reported). Concomitant medication was not reported. No adverse effect reported. There was not a product quality involved. This is one of the several reports from the same source. Additional information has been requested.
ACUTE NON ST ELEVATION MI HYPOTENSION HYPOXIA CARDIOGENIC SHOCK
Tinnitus in both ears. No other medications or events that could have triggered. I?m reporting this because it needs to be studied & patients need to be warned as possible side effect. It is constant, annoying, & never had hearing issues prior, so the timing is suspect.
I had an earache, sore throat, congestion. I did take a home COVID-19 test that came back negative. I made an appointment to see my doctor, who did an examination. He felt that I may have a virus that was causing me to have a common cold. He prescribed an antibiotic that I started that day. I am now feeling so much better.
Vomiting, chills, fever, bodyaches, headache, nausea, diarrhea
Patient developed pain in her left calf 4 days after the 1st Pfizer COVID-19 vaccine. She was sent for venous doppler and found with an extensive superficial venous thrombosis in the left great saphenous vein that was only cm from the deep system.  The clot extended from the upper calf to the thigh.  She was and is being treated for DVT as the clot was so extensive.  She has no history of clots. She does have varicose veins and has not been as active as usual.  She is currently still in treatment .
Parent reported swelling and redness. Physician prescribed Augmentin and Benadryl.
Two days after the injection I had a series of bumps that looked like bug bites all over both of my arms and even onto my fingers. They were itchy and I applied topical antihistamines and also had (1) 24 hr over-the-counter antihistamine.  Now, exactly one week later, I am having difficulty breathing. It feels like someone jumped on my chest. This pain started around noon and is still continuing now (7:00 PM). When I turn my head to the right, it seems to get worse; I have pain also in my neck and down my spine until equivalent to my chest.
I am having a strain in my thigh area on my left side.  I was moving boxes around at work today 3/29/21 and is wondering if that had anything to do with it.
Twenty to thirty vesicular lesions noted, onset 2 days prior to exam. Exposed to chicken pox at school past several weeks. Afebrile.  Benadryl po, Aveeno bath and fluids.
Aug or Sep90 pt vax;  devel measles.  Not confirmed by lab analysis.
tingling; numbness in foot; This spontaneous case was reported by a pharmacist and describes the occurrence of PARAESTHESIA (tingling) and HYPOAESTHESIA (numbness in foot) in a 40-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7167B) for COVID-19 prophylaxis.     The patient had received other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: Influenza vaccine. Past adverse reactions to the above products included No adverse event with Influenza vaccine.    On 31-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 01-Nov-2022, the patient experienced PARAESTHESIA (tingling) and HYPOAESTHESIA (numbness in foot). At the time of the report, PARAESTHESIA (tingling) and HYPOAESTHESIA (numbness in foot) was resolving.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. It was reported that a patient reported to pharmacist today that experienced tingling and numbness in foot the next day after receiving his Moderna Bivalent booster dose. Treatment information was not provided.
First 3 days after injection on 1/14/21, there was soreness and slight swelling with a bit of redness. It went away after 3 days and no other symptoms. 10 days later, small rash consisting of lots of red spots near site of injection. Day 11, the red bumps are no longer visible but a large singular pink rash that's elevated and localized to the injection site with some itchiness, arm fatigue and warmth.
This case was reported in a literature article and described the occurrence of amyotrophic lateral sclerosis in a 21-year-old subject of unspecified gender who was vaccinated with HPV vaccine (manufacturer unspecified). The subject's medical history included purpura fulminans and varicella. Concurrent medical conditions included hypothyroidism and motor developmental delay. On an unspecified date, the subject received an unspecified dose of HPV vaccine (administration site and route unknown, batch number not provided). 270 days after vaccination with HPV vaccine, the subject experienced amyotrophic lateral sclerosis and pharyngeal-cervical brachial variant Guillain Barre syndrome. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the events was unspecified. The author considered the events were unlikely to be related to vaccination with HPV vaccine. This case has been linked to case B0739797A : same literature article. Summary of the literature article: In 2004 the Clinical Consult Case Review (CCCR) working group was formed within the CDC-funded Clinical Immunization Safety Assessment (CISA) Network to review individual cases of adverse events following immunizations (AEFI). Cases were referred by practitioners, health departments, or CDC employees. Vaccine Adverse Event Reporting System (VAERS) searches and literature reviews for similar cases were performed prior to review. After CCCR discussion, AEFI were assessed for a causal relationship with vaccination and recommendations regarding future immunizations were relayed back to the referring physicians. In 2010, surveys were sent to referring physicians to determine the utility and effectiveness of the CCCR service. CISA investigators reviewed 76 cases during 68 conference calls between April 2004 and December 2009. Almost half of the cases (35/76) were neurological in nature. Similar AEFI for the specific vaccines received were discovered for 63 cases through VAERS searches and for 38 cases through PubMed searches. Causality assessment using the modified WHO criteria resulted in classifying 3 cases as definitely related to vaccine administration, 12 as probably related, 16 as possibly related, 18 as unlikely related, 10 as unrelated, and 17 had insufficient information to assign causality. The physician satisfaction survey was returned by 30 (57.7%) of those surveyed and a majority of respondents (93.3%) felt that the CCCR service was useful.  The author's conclusion stated that the CCCR provides advice about AEFO to practitioners, assigns potential causality, and contributes to an improved understanding of adverse health events following immunizations.
pt became lethargic & difficult to arouse 20 mins p/immun given; also had poor weak cry; R56; HR 158 good color; pt observed closely & stimulation provided w/ pt awareness; pt taken to hosp;
uncontrollable shakes that lasted approximately an hour, followed by a fever for over 24 hours and extreme tiredness  for 48 hours, lump in the arm pit area
The middle of the night 1/8/2021, awoke with fever, severe chills and teeth chattering, body aches, rapid heart rate 120s, headache, severe arm pain and very swollen and hot.   A few hours later diarrhea started.  By Saturday morning 1/9/2021, everything had resolved but dull headache and continued diarrhea which lasted for about 3 days.  I rested, used ice on the arm, and took Tylenol.
Pt. reported feeling  "headache" across frontal portion of head, along with feeling "flushed".  Reports pain initially 7/10 of pressure to head. Vitals:  10:35am  128/96 74 18;  10:40am  126/94 76 18;  10:45am  122/92 72 18;   Disposition:  Refer pain 2 on a scale of 0-10 to head.  Pt. left via personal vehicle @ 11:00am.
Low back pain, and asthma problems, tinnitus, sinusitis, migraine, headache, allergic, joint pain, skin rash etc, vision. 02/06/07-records received and reviewed DX: Asthmas bronchial mixed hyperlipidemia allergic rhinitis DDD-Lumbo sacral spine Chronic back pain GERD sleep problems chronic bronchitis nos abnormal glucose tolerance test hyperlipidemia chronic sinusitis asthmas, unspecified chronic back pain arthralgia surgical history left knee meniscus repair 2001 obstructive sleep apnea.
Patient was a 12 year old girl that received a DT booster for a bilateral foot wound. Based on the patient's age, she should have received the Td vaccine, which has less diphtheria compared to the DT vaccine. No harm or loss of therapeutic effect is believed to have resulted from this event.
This spontaneous report was received from a medical assistant concerning a 15-year-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 29-MAR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot number: L026602, expiration date: 29-MAR-2016, dose, dose number, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
The night of the vaccine I had a lot of body pain and head pain. I took Tylenol for pain but my respiratory system collapsed I had trouble breathing. I use my Asthma medicine days after I went to the doctor with intense body pain I fractured my toes. The doctor sent me to Therapy for the next week, I was in bed for 6 days I almost died from intense symptoms from the vaccine.
Pt recvd 1st dose of Engerix-B & exp a migratory allergic reaction; 12NOV92 noticed red nodule on finger; 13NOV92 hand swollen to elbow & adm to hsop; dx was acute cellulitis secondary to allergic reaction; 16NOV92 devel swelling & soreness
Vaccine that administered beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     It was unknown if the patient had ever been diagnosed or tested positive for COVID-19. It was reported, acute illness at the time of vaccination and up to one month before and chronic or long-standing health conditions were unknown.  On 26-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 26-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) outcome was unknown.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient age was reported as 28 years 9 months.  No concomitant medication was reported by reporter  No adverse reactions were reported by the patient after the administration of vaccine. Vaccine code was reported as 80777-0273-99. No treatment medication was reported by reporter
t104, convuls, glands swollen, no rash; Given APAP 1/2 hrs a/convuls; P fast, very lethargic, sponge bath & inc APAP, Amoxicillin;
Pt vaccinated with DTP/OPV had loss of head control, screaming & vomiting, sleep loss; limbs tense also developed seizures. Hospitalized multiple times between 9-12/89. Received DT, condiiton worsened; died 18ARP90.
Covid break through case. Had lunch with a coworker on May 10 contact tested positive. I took extra precautions n95 mask and distanced myself from everybody friends co-works and family. Saturday afternoon allergy like symptoms itchy throat and that evening I also had major muscle aches. I went to bed early and had a restless night. Sunday was a bad day I tested positive on a Antigen At home test. Throughout Sunday they got worse muscles ache, headache, congestion was worse as well and fever was new. I took Tylenol and Advil at home on Sunday and it helped some but didn't fix everything.
Expired Havrix adminsitered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 34-year-old male patient who received HAV (Havrix) (batch number H4H53, expiry date 30-JAN-2023) for prophylaxis.   On 20-MAR-2023, the patient received Havrix. On 20-MAR-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired Havrix adminsitered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 24-MAR-2023 The reporter was a retired nurse. The reporter did consent to follow up. The patient received a Havrix vccine which was already expired, which led to expired vaccine used.
Patient presented to ED with left sided abdominal pain/fever x 1 day.  Differential diagnosis renal infarct versus pyelonephritis.
Moderna COVID-19 Vaccine EUA  Left arm pain started 15 min post vaccination and has not subsided.  General fatigue started 2 hours post vaccination and has not subsided.  Nausea started 5 hours post vaccination and subsided by 4:45AM the following day.  Tinnitus usually sits at 2 on a scale of 1 to 10 with 10 being obnoxiously loud and distracting causing lack of concentration.  Tinnitus started to increase 2 hours post vaccination and topped out at about 8 at around 6 hours post vaccination.    Could not sleep well and maybe got 2 hours of sleep due to tinnitus and increasing left arm pain.