chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Night sweats, intense muscle soreness in upper back-- not just arm, but mostly neck. Also tiredness
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 19-MAY-2014, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 05-APR-2016, the patient was treated by a physician for a blistering vesicular outbreak and decreased immune symptoms, which was then diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient 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. The outcome of the events is unknown. Additional information has been requested.
Patient came back to the pharmacy on 05/08/2018 showing the pharmacist her rash at the site of the injection. The rash was about 1.5 inch wide and 4 inches long down toward the elbow. It was firm and warm to touch. Patient stated that she started notice that the same night she got the shot. She tried to put some ice on but it didn't help. Other than that, patient didn't report any other problem.
the second shot is due that he received his 1st shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (the second shot is due that he received his 1st shot) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Apr-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 (the second shot is due that he received his 1st shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (the second shot is due that he received his 1st shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   Treatment information was not provided
Case number PHEH2014US024270, is an initial spontaneous report received from a nurse on 02 Dec 2014, with a follow up received from nurse on 21 Jan 2015. This report refers to a 58 years old female patient. Her medical history was not reported. Concomitant medications were none. She was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) intramuscularly into the left deltoid at a dose of 0.5 ml on 05 Nov 2014. Nurse reported that PFS of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. The patient did not experience any adverse reaction due to the maladministration (incorrect storage of drug). No further information was provided. Follow up received from nurse on 21 Jan 2015: updated site of vaccination and reporter comment.
Information has been received regarding a case in litigation concerning a male child who was injected with vaccinations containing the mercury-based preservative thimerosal during the period from September 1997 through January 1999. The alleged result of these vaccinations is that the pt suffers from and in the future will continue to suffer toxic neurological effects of mercury poisoning. Vaccination history: a first, second, and third dose of hep B virus vaccine were given on 9/15/97, 11/17/97 and on 4/27/98. First, second, third and fourth doses of Haemophilus B conjugate vaccine was given on 9/15/97, 11/17/97, 1/20/98 and 10/26/98. First, second, third and fourth doses of diphtheria toxoid (+) tetanus toxoid vaccine was given on 9/15/97, 11/17/97, 1/20/98 and 1/25/99. First, second and third doses of poliovirus vaccine was given on 9/15/97, 11/17/97 and 1/25/99. A first dose of MMR II was given on 10/26/98 and a first dose of varicella virus vaccine was given on 7/20/98. Upon internal review, mercury poisoning and neurological disorder were considered to be other important medical event (OMIC). Upon request complete medical records are available. No further info is available.
10.10 Received H1N1 developed rhinorrhea/congestion body aches fever 10.17 - develops headaches 10.19 - Given TAMIFLU 10.20 - Visits hospital ED10.21 Dx with encephalitis.
no additional adverse event; Office manager reports that MMR II was administered to three patients after the product's expiration date. Office manager confirms the product was stored appropriately prior to administration and had no temperature excursions. HCP came onto the line; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 27-OCT-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rHA) (M-M-R II)  (expired product administered) 0.5 milliliter, lot #T029549, expiration date reported as 01-SEP-2022, but upon internal validation was established as 10-SEP-2022 (strength, dosage regimen, anatomical location, and route of administration were not provided) as prophylaxis. The reporter stated that the product was stored appropriately and had no temperature excursion prior administration. No adverse event was reported.  This is one of three cases reported by the same reporter.; Sender's Comments:  US-009507513-2210USA010243:AE report #: 02276158 US-009507513-2210USA010287:
This spontaneous report as received from a medical assistant via a company representative and refers to a currently 8 year 9 month old patient of unspecified gender. Vaccination history included: On 30-DEC-2005 (dose 1), 05-MAR-2006 (dose 2), 09-MAY-2006 (dose 3)0, 30-OCT-2006 (dose 4), 29-MAR-2010 (dose 5): DTP/DTaP/DT (manufacturer unknown). On 30-DEC-2005 (dose 1), 05-MAR-2006 (dose 2), 09-MAY-2006 (dose 3), 09-MAY-2007 (dose 4); (unspecified carrier) HIB (manufacturer unknown). On 30-DEC-2005 (dose 1), 05-MAR-2006 (dose 2), 09-MAY-2006 (dose 3), 29-MAR-2010 (dose 4) poliovirus vaccine (unspecified) POLIO (manufacturer unknown). On 30-OCT-2006 (dose 1) and 29-MAR-2010 (dose 2) MMR (manufacturer unknown). On 29-OCT-2005 (dose 1), 30-DEC-2005 (dose 2), 06-MAR-2006 (dose 3) and 09-MAY-2006 (dose 4) hepatitis B virus vaccine (unspecified) HEP-B (manufacturer unknown)0. On 30-DEC-2005 (dose 1), 05-MAR-2006 (dose 2), 09-MAY-2006 (dose 3), 04-MAY-2007 (dose 4) and 16-SEP-2010 (dose 5) (unspecified) PNEUMO PCV (manufacturer unknown). On 30-OCT-2006 (dose 1) and 04-MAY-2007 (dose 2) (unspecified) HEP-A (manufacturer unknown). On 08-NOV-2010 (unspecified) (reported as FLU). On 30-OCT-2006 (dose 1) and on 29-MAR-2010 (dose 2) the patient was vaccinated with (Oka/Merck) VARIVAX (reported as CHICKENPOX) (dose, units, route of administration, anatomical location, lot number were not reported). On an unknown date the patient experienced chickenpox/chickenpox describes as spots and fever. The outcome of event was reported as not recovered/not resolved. The relatedness between event and (Oka/Merck) VARIVAX was not reported. This is one of several reports from the same reporter. Additional information is not expected because address was correctly entered but the correspondence was returned.
Pt was given shots on 9/5/19 and later that evening mom called and stated pt started to run a fever. Pt was taken to the ER and had a fever of 101-1'F. Pt was seen and Dr discussed with mom outcome of testing and what to watch for and when to bring back to Er.
Son was warm, Had bad dreams (snake on ceiling). Was cold & shaking. Mild fever, Felt like throwing up. Next morning was weak + Pale. heart racing. Couldn't walk
Patient received a Pfizer COVID vaccine for her second dose of the series, first dose given was Moderna on 6/18/2021. Patient is aware of mistake, reporting no symptoms currently.
presented with SOB; admit with Covid PNA;tx with maxipime, remdesivir, steroid, singulair, zinc, supplemental O2;
Fever, shaking, muscle spasms, inability to control my body. Stomach aches
This spontaneous report was received from a healthcare worker refers to a patient of unknown demographics. There were no pertinent medical history, current conditions reported. It was unknown the patient was vaccinated with PNEUMOVAX 23, (dose, frequency, lot#, route not reported). No concomitant medications reported. On an unknown date medication error was reported were doses of PNEUMOVAX 23 were exposed to highest temperature of 53F for 21 hours. The healthcare worker does not know whether or not any of these improperly stored doses were administered to any patients since these excursions occurred. This case is linked to 1403USA012856, 1403USA012857, 1403USA012858, 1403USA005464, 1403USA012860 (same reporter link). Additional information has been requested.
Generalized itching. Employee given dose of 25mg of diphenhydramine after no response after 30 min, another dose of 25mg of diphenhydramine was given. Employee stopped itching and remained asymptomatic.
lack of appetite; body shaking; I could not go back to sleep; just really debilitating; Fever at 100.5; chills; Pretty bad nausea; Teeth chattering; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (lack of appetite), TREMOR (body shaking), INSOMNIA (I could not go back to sleep), ASTHENIA (just really debilitating) and PYREXIA (Fever at 100.5) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history provided.).    On 23-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced DECREASED APPETITE (lack of appetite), TREMOR (body shaking), INSOMNIA (I could not go back to sleep), ASTHENIA (just really debilitating), PYREXIA (Fever at 100.5), CHILLS (chills), NAUSEA (Pretty bad nausea) and CHILLS (Teeth chattering). At the time of the report, DECREASED APPETITE (lack of appetite), TREMOR (body shaking), INSOMNIA (I could not go back to sleep), ASTHENIA (just really debilitating), PYREXIA (Fever at 100.5), CHILLS (chills), NAUSEA (Pretty bad nausea) and CHILLS (Teeth chattering) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  Treatment information included Tylenol all day throughout the day on 23 Feb 2021.   Reporter did not allow further contact
Breaking out of red rashes and welts, all over body in various places, coming and going every 30-60 minutes,  day and night until passed out from exhaustion. Burning and itching sensations are signs of a new outbreak.  Treatments, penetrex and aloe gel for really burning sensations.  After 7 days prescribed prednisone, 60mg day1, tapering down 10mg per day, currently on day 2.  currently just finished amoxicillin and sinus infection gone. trying to stay off antihistamines.  Currently day 8 since shot, with prednisone feeling less burning / very little welting. Still a nuisance and a distraction but less so.
Sore Throat  immediately tasted alcohol and immediately started with a dry cough and sour throat, before the shot she had no sore throat or Cough
Information has been received from a consumer concerning her son, a 5 year old male who allergic to amoxicillin who was vaccinated with one dose of MMR II, oral. Subsequently the patient experienced developmental delays and asthma and was hospitalized "overnight". The patient did not perform lab diagnostics study. At time of the report the patient's developmental delays and asthma were not recovered. The patient's brother also had an adverse event after vaccination with MMR II (WAES # 0902USA01776). No further information is available.
No additional AE's reported; HBP reporting AE for improperly stored administered vaccine.; This spontaneous report has been received from a office manager and refers to a 4-week-old patient of unknown gender.  The patient's pertinent medical history, previous drugs reactions or allergies, and concomitant medications were not reported.  On 16-MAY-2022, the patient was vaccinated with an improperly stored hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, administered for prophylaxis (lot number U032668, which was confirmed to be valid, and expiration date: 24-APR-2023) (dose, vaccination scheme frequency, anatomical location and route of administration were not provided). The administered dose of the vaccine experienced a temperature excursion of 28 degrees Fahrenheit for 96 hours (product storage error). No previous temperature excursion was reported. No additional adverse event was reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2205USA005673:case number 02168906 US-009507513-2205USA005621:case number 02168912
lymph nodes side effects from the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (lymph nodes side effects from the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (lymph nodes side effects from the vaccine). At the time of the report, LYMPHADENOPATHY (lymph nodes side effects from the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported.  Patient mentions how he has been doing research online and read about how women get false alarm due to lymph nodes side effects from the vaccine and how it affected mammograms.  The treatment information was not  provided.
30th stiff neck swollen glands and nodes high blood pressure fatigue. Ibuprofen shot . 3rd covid arm swollen burning dripping. Swollen colarbone and neck. 7th still swollen tramadol shot.
Pt given Tdap on 6-17-11. Next day arm was sore. Soreness continued couldn't lay on arm. By Monday pt had difficulty moving arm. On Tues 6/21 pt couldn't move arm. Pt saw MD on 6/22 Dr said to take ibuprofen (could not rotate arm without acute pain).
Pt recv vax on unspecified date; subsequently pt exp injection site rx of redness &swelling.
A spontaneous report was received from a physician on 18-Jan-2021 concerning a female patient of an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) while pregnant.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On an unknown date, during pregnancy patient received their first of two planned doses of mRNA-1273 (batch number not provided) via an unknown route for COVID-19 infection.   On an unknown date, the patient became pregnant. LMP and estimated delivery date was not reported.    Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event pregnant was unknown.  The reporter did not provide causality assessment for event pregnant with mRNA-1273 vaccine.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient of an unknown age. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. The causality of pregnancy was assessed as not applicable.
pt recv vax 14MAY96 & same day achiness;15MAY inc achiness & backache, inc back pain, sleeplessness d/t pain & discomfort;called ER-told to seek med tx;17MAY cramps & pain everywhere, multiple muscle contractions, weak,neck stiff & sore
Pt recv vax on 4/8/99; 1 min post vax pt exp wheal/ red at vax site; 3 min post vax pt exp cough, attempting to vomit; tx=Epinephrine, Benadryl, Prelone
Information has been received from a certified medical assistant referring to a 7 month old patient of unknown gender. On 19-MAY-2015, the patient received a dose of RECOMBIVAX HB, strength 2.5 mcg/0.5 ml, dose and lot number not provided) and a dose of PEDIARIX (dose and lot number not provided) (overdose). No adverse effects reported. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In September 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage, and route of administration not provided), at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2016, the patient was treated for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient 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.
Presnted to ED with SOB due to COVID PNA. Admitted to ICU where she was started on steroids and lasix to remove fluid around her lungs. Transfered to floor later that evening after nicardipine gtt finished. Patient remained on floor for a few more days until recovered enough to return home.  Patient had first dose of COVID vaccine followed by a positive COVID test at the hospital 22 days later.
pt recvd vax 3JUL92 & exp immed myalgia & arthralgia; seen by MD who felt that pt should discontinue the vax series; MAR93 it was reported that pt sx persisted; No further details were provided;
Information has been received from a physician concerning an approximately 17 year old female who on 04-JUN-2007 was vaccinated with a 0.5 ml second dose of Gardasil (lot# 655205/1426F). Concomitant therapy included Cymbalta, Lamicatal, Synthroid, Ortho-Novum, Claritin and "500 fiber therapy". On 19-JUN-2007 the patient went into the office with redness, swelling and itching "beyond normal" around the injection site. The physician did not administer the first dose and was not aware of a previous similar reaction. At the time of the report the patient was recovering from redness, swelling and itching around the injection site. There were no diagnostic or laboratory test performed. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/16/2007.  Initial and follow-up information has been received from a physician concerning a 17 year old female, with a history of depression (2001), irritable bowel syndrome, abdominal pain, hypothyroidism (June 2006), ankle instability, fungal dermatitis, Hashimoto's thyroiditis, allergy to GARDASIL, who on 04-JUN-2007 at 4:51 pm, was vaccinated IM in the left deltoid with a 0.5 ml second dose of GARDASIL (lot # 655205/1426F).  Concomitant therapy included CYMBALTA, LAMICTAL, SYNTHROID, (ORTHO-NOVUM 7/7/7), CLARITIN and "500 fiber therapy".  On 06-JUN-2007 (previously reported as 19-JUN-2007) the patient went into the office with redness, pain, swelling and vesicular itching "beyond normal" around the injection site.  On 18-JUN-2007 the patient had recovered.  The physician did not administer the first dose, and was not aware of a previous similar reaction.  There were no diagnostic or laboratory tests performed.  Additional information is not expected.
On 2/28/21 a used vial of vaccine was reconstituted again with sodium chloride, they were reconstituted in error and patient received diluent only immunization. The immunization administered that day was not effective in providing protection against COVID.   Patient did not have any adverse reaction to the sodium chloride and returned on 3/6/21 to receive the correct dosage of vaccine.
Information has been received from a medical assistant referring to an unspecified patients of unknown age and gender. On unknown dates, since 01-OCT-2015, the patients were vaccinated with doses of ROTATEQ (lot # K024700, expiration date 30-JUL-2016, dose unknown) that were exposed to temperatures outside of the recommended range. No adverse experience was reported. This is one of two reports received from the same source. Additional information has been requested.
This report is in relation to acute sudden onset tinnitus in left year one day following first shot of COVID vaccination. Received first COVID vaccine shot in my left arm. I felt a bit tired and foggy but nothing too bad or out of the ordinary. Exactly 31 hours later, I was talking with my daughter when a very loud ringing noise entered my ears. It subsided slightly but then a persistent ringing -- tinnitus -- remains in my left ear. I saw an audiologist who indicated a slight dip in hearing acuity in the left ear at a higher pitch. I am currently on prednisone (20mg 1x per day) and doxycycline but it has been 4 days with no dissipation or relief. I have not suffered from tinnitus before.
About 8 1/2 hours post-vax, the patient developed a fever of 104F along with nausea, vomiting, diarrhea, and loss of appetite. Mother states symptoms would decrease somewhat with Tylenol, but would not completely go away for 4 days.
Several hours after getting the high dose flu vaccine patient developed fever, rash, severe arthralgias/myalgias, progressive malaise. Patient was admitted x 4 days, Tx'd with ABX & steroids.
I am still weak extremely weak. My headaches are better but I still have them. Soreness where shot and spine extremely sore. Ache all over dizzy, lightheaded, bedridden. Fall if walk. Too dizzy. My spine is hurting.
Large red rash/circle (about 1 inch in diameter) on and around the injection site. Pt was started on BENADRYL that night and had an appt with the pediatrician in 2 days. Pt was started on BENADRYL and ZYRTEC at that point by the physician.
Shot was given around 12:15 pm. Around 2:00 pm I began to feel dizzy and flushed. (I had patients tell me that I was white)