chrisvoncsefalvay/vaers-outcomes huggingface dataset:
left hand got like rigor mortis in the morning; swollen like he has gout in his left hand; his index finger is hooked; Achy in joints; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE RIGIDITY (left hand got like rigor mortis in the morning), PERIPHERAL SWELLING (swollen like he has gout in his left hand), FINGER DEFORMITY (his index finger is hooked), ARTHRALGIA (Achy in joints) and CHILLS (chills) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced ARTHRALGIA (Achy in joints), CHILLS (chills) and PYREXIA (fever). On 08-Apr-2021, the patient experienced MUSCLE RIGIDITY (left hand got like rigor mortis in the morning), PERIPHERAL SWELLING (swollen like he has gout in his left hand) and FINGER DEFORMITY (his index finger is hooked). On 08-Apr-2021, ARTHRALGIA (Achy in joints), CHILLS (chills) and PYREXIA (fever) had resolved. At the time of the report, MUSCLE RIGIDITY (left hand got like rigor mortis in the morning), PERIPHERAL SWELLING (swollen like he has gout in his left hand) and FINGER DEFORMITY (his index finger is hooked) had resolved.            Patient had chills, achy in the joints, and fever for two days. A day or two after the second dose, his left hand got like rigor mortis in the morning, like arthritis, swollen like he has gout in his left hand and his index finger is hooked. This occurs only in the morning and resolves itself after 10-15 minutes.  Action taken with mRNA-1273 in response to the events was not applicable.  Concomitant and treatment information were not provided.   This case was linked to MOD-2021-101879 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow up information reported PT term of events muscle rigidity (left hand got like rigor mortis in the morning), peripheral swelling (swollen like he has gout in his left hand), finger deformity (his index finger is hooked)..
This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 67-year-old female patient who received SHINGRIX. On 29th May 2018, the patient received the 2nd dose of SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced pain, feeling hot, fever, injection site erythema and injection site swelling. On an unknown date, the outcome of the pain, feeling hot, fever, injection site erythema and injection site swelling were unknown. It was unknown if the reporter considered the pain, feeling hot, fever, injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the left deltoid. The patient complained redness and swelling at the injection site, fever and body temperature was recorded as 100 F, soreness, hot to touch and pain.
second dose of Moderna was given on day 21 and not day 28. Given 7 days early. Spoke to patient and he had no adverse reactions to report.
Patient's mother diagnosed (2-3 weeks ago) & patient broke out with scattered erythema- four vesicular lesions face, arms, chest - but only a few. No other  S&S. Lesions are drying.
fatigue; vaccination site pain; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (vaccination site pain) and FATIGUE (fatigue) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    The patient's past medical history included No adverse reaction (no medical History Reported ).   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient received dose of ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PAIN (vaccination site pain) and FATIGUE (fatigue). At the time of the report, VACCINATION SITE PAIN (vaccination site pain) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Connective tissue discomfort starting approx 3 weeks after COVID vaccine. Pain remains ongoing since 11/2021. Pt referred to rheumatologist and for head CT but refuses.
Initial unsolicited report received from a Nurse (LPN) on 05-Jun-2018. This case involves a patient (age and gender was not reported), who was vaccinated with a dose of PENTACEL (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. It was a case of actual medication error due to expired vaccine used one patient, received dose that had expired. No adverse event was reported. 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. Documents held by sender: none.
This spontaneous report was received from a pharmacist refers to one of the two patients of unkonwn age and gender. Patient medical history and historical conditions were not reported. On 12-SEP-2014, the patient inadvertently administered ZOSTAVAX single dose, subcutaneous (dose was not reported) (lot # J004599 and expiration date was 18-JUL-2014), that had expired in 18-JUL-2014. Concomitant therapy was not reported. No adverse effects reported. No PQC was involved. The outcome of inadvertently administered ZOSTAVAX that had expired in 18-JUL-2014 was unknown. The reporter considered inadvertently administered ZOSTAVAX that had expired in 18-JUL-2014 to be not related to ZOSTAVAX. This case was linked to MARRS# 1409USA007128 (same patient link). Additional information has been requested.
Severe pain, decreased ROM, bone damage because shot was placed in shoulder. Received physical therapy and arthroscopic surgery on 10/16/2007. Continues to have pain in shoulder and numbness to hand to the present time.
Bad Ache; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. No patient demographics available at the time of the call. The pharmacist stated that the patient who complained that the solution going in upon Shingrix administration and had really bad ache. The reporter has been given the consent for the follow up. This case is 1 of 2 cases, reported by the same reporter.
About 28 hr after receiving Tdap, patient broke out in hive-type rash on abdomen with itching (3-28-07) night of 3-28, felt light-headed and dizzy. Fell am of 3-29, rash over abdomen, back, arms and legs. Benadryl gave partial relief. Am of 3/30, rash still present with swelling of fingers. Saw Dr on 3-29 and 3/30. RX for predisone PO on 3-30.
Chills; Exhaustion; Bad headache; This is a spontaneous report from a contactable consumer, the parent. A 23-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration on 07Apr2021 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021, the patient experienced chills, exhaustion and bad headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events chills, exhaustion and bad headache were not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Loss of muscle tone/strength from the waist down, symptoms went away on it's own by 9/10/16.
MMR-V Proquad is given on 10/4/06 with Hib. After one month, he developed thromboycytopenia treated for idiopathic thrombocytopenia purpura. Due to persisted thrombocytopenia most likely reason is vaccine associated thrombocytopenia.  02/06/2007: MR received from 2 hospital admissions for easy bruising related to low platelets which had been occuring for approximately 2 weeks.  No epistaxis or other bleeding noted. Sent to ER from Pediatrician's office where platelet count was found to be 7000.  He was admitted and treated with Rhogam.  Two weeks later he was re-admitted for increased bruising again and treated with IgG.  PE: WNL except multiple areas of ecchymosis of lower extremities, chest, forearms, and face on both admissions. Petechia noted on face, arms, legs, and buttocks on 11/16/06. Discharge DX on 11/18/2006: Idiopathic thrombocytopenic purpura. Discharge DX on 11/29/2006: 1) Thrombocytopenia IgG  2) Anemia.  02/19/2007: MR received from PCP.  Infant in for 1 yr. check-up on 10/04/2006 with c/o sores in mouth and recurrent rash x several days.  Fever for 2 days noted, now doing well. Child with DX: of Herpangina given Proquad and Pedvax. Seen again 10/25/2006 for cold sx. and conjunctivitis. Several hospital F/Us for ITP with repeated labs. DX: ITP.
The arm hurt a little bit after 1st shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (The arm hurt a little bit after 1st shot) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Combigan (once a day). Concomitant products included OMEPRAZOLE, LEVOTHYROXINE, HYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMIL (OLMESARTAN HCTZ), DILTIAZEM, PREDNISOLONE ACETATE and OFLOXACIN from an unknown date to 13-Sep-2021 for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (The arm hurt a little bit after 1st shot). At the time of the report, PAIN IN EXTREMITY (The arm hurt a little bit after 1st shot) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was reported.   This case was linked to MOD-2021-320953, MOD-2021-320932 (Patient Link).
Pt recvd vax 29APR92 & approx 30 mins later devel hives & that evening exp abdo cramps & nausea; the following day still exp abdo discomfort & felt lousy;
head congestion and cough  Acute bronchitis, unspecified organism  Office Visit 6/18/2021 WellSpan Internal Medicine - Dover  Internal Medicine Pneumonia due to COVID-19 virus Dx URI Reason for Visit Progress Notes (Physician) ? ? Internal Medicine ? ? Encounter Date: 6/18/2021 ? ? Signed Expand AllCollapse All      Assessment/Plan      Diagnoses and all orders for this visit:   Pneumonia due to COVID-19 virus   Other orders -     predniSONE (DELTASONE) 10 mg tablet; 10 mg tablets 6 tablets on the first day followed by reducing the dose by 1 tablet each day for 5 more days.6,5,4,3,2,1 -     fluticasone propionate (FLONASE) 50 mcg/actuation nasal spray; Administer 2 sprays into each nostril daily     He continues to experience fatigue, cough, generalized weakness.   Start him on prednisone taper again   His insulin need to be adjusted because prednisone can raise his blood sugars.   I recommend he contact his endocrinologist regarding this.   Advised him not to take hydrocortisone while he is on prednisone.   Advised him to monitor his oxygen level at home.   I recommend he stay home to rest.  No need for quarantine anymore. Stay home to rest until June 27.   He can return back to work on June 28 without restrictions.
Initial report received on 01 March 2007 from an other manufacturer (no report number), who received the report through their National Service Center from a nurse in the United States. The other manufacturer forwarded the report to mfr, who forwarded the report to mfr. A female patient, with a history of allergy to lactose, had received an INFLUENZA vaccine as a child. The date of vaccination, trade name, manufacturer name, route and site of administration were not reported. Reportedly, at an unspecified amount of time later, the patient "was paralysis" for about three days. The patient subsequently sought medical attention and intervention to prevent serious criteria. Reportedly, the patient recovered.
Tested positive for covid 3/11/2021.  Symptoms include runny nose and feeling "depressed"
headache; fatigue; feels achy; This case was reported by a consumer and described the occurrence of headache in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In September 2021, less than a week after receiving Shingrix, the patient experienced headache, fatigue and pain. On an unknown date, the outcome of the headache, fatigue and pain were not recovered/not resolved.   It was unknown if the reporter considered the headache, fatigue and pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The patient received Shingrix and experienced headache, fatigue and felt achy. The reporter did not consent to follow up.
tested positive for Covid; tested positive for Covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EL3247), on 17Mar2021 as dose 2, single (Lot number: EN6203), on 15Dec2021 as dose 3 (booster), single (Lot number: FF8839) and on 14Jun2022 as dose 4 (booster), single (Lot number: FL3197) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATENOLOL; HYDROCHLOROTHIAZIDE; ATORVASTATIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Aug2022, outcome "unknown" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Patient experienced congestion, cough, headaches, sore throat, and overall achiness on 06Aug2022 then tested positive for COVID on 09Aug2022. No other vaccine in 4 weeks. No COVID prior vaccination.   No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning a 16 year old female patient who on 27-DEC-2007 was vaccinated with a first dose 0.5 ml of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # unknown).  The physician reported that patient, on 29-DEC-2007, two days after being vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) experienced a seizure and was subsequently hospitalized.  It was reported that at the time of this report patient just had headaches.  No further information was provided.  Additional information has been requested.  3/26/09 ER record received for DOS 12/29/07 with  DX:  Seizure-new onset. Pt presented to ER after an episode of loss of consciousness, falling and shaking of extremities, eyes rolling up and foaming at the mouth.  Post ictal during EMS ride to ER with confusion.   WNL upon arrival at ED. D/C for outpt f/u. No further records available from PCP due to fire in office.  Unknown if pt has had further sx or if under a neurologist's care. 5/19/09 neuro consult received dated 2/5/08 with f/u 3/27/08 with dx: Episode of seizure etiology unclear.  Pt had just received HPV vax and there is a suspicion that it may be the triggering cause.  PE WNL. No further episodes per parent TC on 5/18/09
Approximately 20 minutes after receiving a Moderna booster dose, patient complained of feeling "hot and flushed". V/S obtained: B/P132/76 P89 R16 o296. Patient waited and monitored by nursing staff in 15 minute monitoring zone for 30 minutes.  Before leaving patient was offered further medical attention via EMS, patient declined and departed the premises.
Rash, itching of arms and legs. Pt was prescribed hydrocortisone cream - should be able to receive 3rd dose (Dr visit 5/8/03).
Febrile 102.9-101. x 24 hrs post vaccine good affect with Tylenol and Benadryl. N/V x 24 hours post vaccine, fatigue, body aches
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 04-MAR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23  0.5ml (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice.  The total cumulative excursion time of the first time was 24 hours with the lowest recorded temperature of -1 Fahrenheit degree. The total cumulative excursion time of the second time was 48 hours with the lowest recorded temperature of 0 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
diarrhea; couldn't eat or drink; blood pressure became elevated; chills; muscle ache; A bad night with his stomach; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (A bad night with his stomach), DIARRHOEA (diarrhea), CHILLS (chills), MYALGIA (muscle ache) and DECREASED APPETITE (couldn't eat or drink) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient had no known allergies.  The patient's past medical history included Heart attack (2 years prior to report) and Shoulder replacement on 15-Dec-2020. Previously administered products included for an unreported indication: FLU (receives flu short yearly). Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (A bad night with his stomach). On 21-Feb-2021, the patient experienced DIARRHOEA (diarrhea), CHILLS (chills), MYALGIA (muscle ache), DECREASED APPETITE (couldn't eat or drink) and HYPERTENSION (blood pressure became elevated). On 21-Feb-2021, HYPERTENSION (blood pressure became elevated) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (A bad night with his stomach), DIARRHOEA (diarrhea), CHILLS (chills), MYALGIA (muscle ache) and DECREASED APPETITE (couldn't eat or drink) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Feb-2021, Blood pressure measurement: elevated (High) elevated; resolved that same day. On 21-Feb-2021, Heart rate: elevated (High) elevated; resolved that same day.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient takes 9 concomitant medications; two are reported. The patient did not take any treatment medications.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: TCR
I had a breakthrough case, I tested positive for COVID 6 months after I got my 3rd dose.
10/29/21: vaccinated at 1pm.  Onset of muscle/joint pain started approx 5pm in left elbow then systematically  each joint one by one until all encompassing.  Fever spiked to 102 with typical chills etc.  10/30/21:  fever aches pains and extreme fatigue for the duration of day.  10/31/21:  intractable nausea/vomiting started with severe stomach pains.  Unable to eat or drink anything x 6 days total. 11/3/21: went to ER for treatment requiring fluids, magnesium, potassium etc.  discharged home after approx 5 hrs.  11/4/21:  no change, continued intractable nausea/vomiting, unable to tolerate food/fluid.  11/5/21:  same pain, chills, nausea vomiting.  11/6/21: starting to sip on soup, pain /nausea/vomiting resolved so far.
This spontaneous report as received from a physician refers to unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored doses of VAQTA (lot # L015460, expiration date 20-JUL-2017; dose and route were not reported). No adverse effects were reported. The vaccines were stored in 33 F for 60 days. The call was made because of the data logger. No previous temperature excursion was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Received vaccine 8/02/05-8/3/05 1 1/2" in diameter hard, red, swollen. Seen 8/4/05 in our office 4" in diameter where Dtap #5 given. Diagnosed as cellulitis treated with antibiotic.
9/2: Same day as administered, within 30 minutes started to have throbbing pain in left arm. Felt achy for 8 days. Couldn't sleep for 5 days, is taking Celebrex 2x day. Helps to be comfortable to sleep at night.