chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in an unspecified number of adult patients who received Shingrix for prophylaxis. On an unknown date, the patients received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patients experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to Shingrix. Additional information received as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. The 5 to 6 patients experienced sore arm. The reporter agreed to follow up from GlaxoSmithKline. This was 1 of the 4 linked cases reported by the same reporter.
Low grade fever, vomiting and diarrhea multiple times over course of 3 days. Received 3 liters of IV fluids in ER and blood work was done.
Narrative: COVID infection following COVID vaccine series 03/19, Pfizer, dose #1 04/08, Pfizer, dose #2 08/12 pt cc: myalgias, rhinorrhea, congestion, dyspnea, sore throat exposure: unknown 08/17 COVID swab, result: detected 08/17 SARS-COV-2 Variant Sequencing result: pending 08/22 clinically resolved 09/10 pt admit to ED cc: stomach pain dx: LUQ abdominal pain LOS: 1 day
I did not feel well for 24 hours; Covid-arm; throbbing headache; tiredness; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (I did not feel well for 24 hours), VACCINATION SITE REACTION (Covid-arm), HEADACHE (throbbing headache) and FATIGUE (tiredness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20a and 030m20a) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Sulfa). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for High cholesterol, VITAMIN D NOS for Vitamin D decreased.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (I did not feel well for 24 hours), VACCINATION SITE REACTION (Covid-arm), HEADACHE (throbbing headache) and FATIGUE (tiredness). At the time of the report, MALAISE (I did not feel well for 24 hours), VACCINATION SITE REACTION (Covid-arm), HEADACHE (throbbing headache) and FATIGUE (tiredness) outcome was unknown.            Treatment included icepack and antihistamine. EpiPen was ordered in case of emergency.  .Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-018146 (Patient Link).
Starting at 6:30 I could feel my body getting tired. Rapidly got chills and an extreme headache. Body aches the entire next day in addition to being extra tired and constant diarrhea.  Had to stay home from work. I haven't felt 100% since, even though it has been over 2 weeks. After my wife got her second shot, our entire household got a suspicious flu like cold, then it happened again right after my second dose. That lasted almost a week each time and just seems unlikely to be a complete coincidence.
red swelling at injection site; red swelling at injection site; tenderness; glands swollen and enlarged/swelling under arm; glands painful; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Oct2021 16:00 (Lot number: FE3590) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII, administration date 08Oct2021. Past drug history included: Yes, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8735, Location of injection: Arm Left, Vaccine Administration Time: 05:00 PM), administration date: 30Apr2021, when the patient was 47 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0172, Location of injection: Arm Left, Vaccine Administration Time: 05:00 PM), administration date: 21May2021, when the patient was 47 years old, for COVID-19 Immunization. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 12Oct2021, outcome "unknown" and all described as "red swelling at injection site"; TENDERNESS (non-serious) with onset 12Oct2021, outcome "unknown", described as "tenderness"; LYMPHADENOPATHY (non-serious) with onset 12Oct2021, outcome "unknown", described as "glands swollen and enlarged/swelling under arm"; LYMPH NODE PAIN (non-serious) with onset 12Oct2021, outcome "unknown", described as "glands painful". The events "red swelling at injection site", "red swelling at injection site", "tenderness", "glands swollen and enlarged/swelling under arm" and "glands painful" were evaluated at the physician office visit.  Additional information: It was reported prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Extreme pain when she lifted a small pharmacy bag; Hurts when she moves her arm / to reach for things, holding the phone or when she sleeps on her left side; Hurts to touch at the indentation of the left clavicle; hurts to touch at left shoulder joint; This case was reported by a consumer via call center representative and described the occurrence of pain in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 22S3B, expiry date 25th March 2022) for prophylaxis.   On 13th January 2020, the patient received the 1st dose of Shingrix (intramuscular). On 13th January 2020, immediately after receiving Shingrix, the patient experienced pain, pain in arm, bone pain and pain in joint involving shoulder region. On an unknown date, the outcome of the pain, pain in arm, bone pain and pain in joint involving shoulder region were recovering/resolving.   It was unknown if the reporter considered the pain, pain in arm, bone pain and pain in joint involving shoulder region to be related to Shingrix.  Additional details were reported as follows: The patient received her first Shingrix vaccine on in her left arm. Immediately after receiving the injection she experienced extreme pain when she lifted a small pharmacy bag. Since the injection she was experiencing extreme pain all the time, it hurts when she moves her arm to reach for things, holding the phone or when she sleeps on her left side. The patient also reported that it hurts to touch at the indentation of the left clavicle and left shoulder joint. The reporter did not consent to follow up.
the refrigerator door was not closed all the way resulting in a temperature excursion at 54.6 degrees F for 10 hours involving medication Lantus, Lantus Solostar, Admelog, Toujeo and Polio vaccine; Initial information received on 31-Jul-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age male patient.  This case involves a refrigerator door was not closed all the way resulting in a temperature excursion at 54.6 degrees f for 10 hours involving medication IPV (VERO) [IPOL] lot N1K931M and expiry date: 19-Nov-2019, INSULIN GLARGINE [LANTUS] (lot - 8F036B, expiry date: 30-Jun-2021), INSULIN GLARGINE [LANTUS SOLOSTAR] (lot - 9F6180A, expiry date: 30-Nov-2021), INSULIN LISPRO [ADMELOG] (lot - 9F105A, expiry date: 28-Feb-2021) and INSULIN GLARGINE [TOUJEO SOLOSTAR] (lot - 9f217A, expiry date: 31-Jan-2021) and with the use of medical devices SOLOSTAR U30 and SOLOSTAR.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a potential medication error due to incorrect product storage.  It was unknown whether the products was administered to the patient or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  List of documents held by sender: none.
When I took the 1st Vaccine I did have arm tenderness on day of injection.; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: not reported) via an unspecified route of administration in arm left on 22Jan2021 at 09:30 (age at the time of the vaccination 61-year-old) as dose 1, single for COVID-19 immunization at Military Base. Medical history included ITP (idiopathic thrombocytopenic purpura), fibromyalgia, PBC (primary biliary cholangitis), parathyroid and GERD (gastrooesophageal reflux disease). Concomitant medications included ursodiol and colecalciferol (VITAMIN D [COLECAL-CIFEROL]) for unspecified indication, start and stop dates were not reported. The patient previously took Zircon and Wellbutrin and experienced allergies. No other vaccine was received in four weeks. The patient had no COVID prior vaccination and not tested for COVID post vaccination. It was reported that, the patient had great body pain all day long. Patient said, on 23Jan2021 at 12: 00, when I took the 1st vaccine, I did have arm tenderness on day of injection. To her surprise she was completely pain free for about a week, she hadn't felt that great in years. Gradually all the pain returned. No treatment was received for the event. On an unspecified date in 2021, the outcome of the event was resolved.  Information on lot number/batch number has been requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Blood clots in lung; Blood clots in leg; clostridioides difficile infection; MARKETING PROGRAM NAME NOT AVAILIBLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4323739-00.  A 73 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Dec2021 (Batch/Lot number: unknown) at the age of 73 years as dose 3 (booster), single, intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (citrate free) for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PULMONARY THROMBOSIS (caused and prolonged hospitalization, medically significant), outcome "not recovered", described as "Blood clots in lung"; THROMBOSIS (caused and prolonged hospitalization, medically significant), outcome "not recovered", described as "Blood clots in leg"; CLOSTRIDIUM DIFFICILE INFECTION (caused and prolonged hospitalization, medically significant) with onset Oct2021, outcome "not recovered", described as "clostridioides difficile infection". The action taken for adalimumab was temporarily withdrawn.  The reporter's assessment of the causal relationship of the (Blood clots in lung, Blood clots in leg, clostridioides difficile infection) with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The reporter's causality for the event(s) of Blood clots in lung and Blood clots in leg with Humira (Adalimumab) was no reasonable possibility.The reporter's causality for the event(s) of Clostridioides difficile infection was not provided. Agency opinion is that the events of Blood clots in lung and Blood clots in leg are not assessable. Agency opinion is that there is no reasonable possibility that the event of Clostridioides difficile infection is related to Humira (Adalimumab).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Considering the temporal association, a causal role of the suspect drug cannot be completely denied for the reported events of thrombosis and pulmonary thrombosis.  Reported event of clostridium difficile infection could be due to an intercurrent medical condition, unrelated to the suspect drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Fever (102.3 at highest), chills, nauseous (threw up twice), sore arm, fatigue
Complained of foreign body sensation in left eye. Seen by ophtho and diagnosed with a corneal ulcer, possibly viral.
Patient states that after receiving the 2nd dose of Pfizer 11/15/2021, started experiencing symptoms 11/16/2021 early morning of sharp back pain, soreness in the shoulder blade (Both), arm movement causing muscle spasms (Spasms subsided in the evening). Soreness remained (Trauma caused description). 11/17/2021 Back pain moved through to the lower back and sides, 11/18/2021 Electric pulses (Left side) Upper leg to the hip side (15 mins intervals). 11/19/2021 Right toe (Top portion) numbness with Electric pulses continued until evening. 11/21/2021 Symptoms slowly subsided, 11/22/2021 Subtle Right eye Blurriness (Haze). Tingling sensation in the right side of the head, Brain Fog. 11/24/2021 Right Eye pressure with Blurriness continue. (Optometrist visit, examine = Normal) Self-Check Blood Pressure = Normal (Primary visit, Blood Work = Normal) 11/26/2021 Ear ringing started in the evening/night. 11/27/2021-12/06 Ear ringing happening 2-3 times a day.  12/16/2021 Shoulder and back pain returned without the Muscle Spasms, 12/17/2021 Symptoms have subsided.
Itching of throat. Treated immediately with Benadryl. Patient has significant history of drug allergies.
Tremor (L) and (R) hand, arm; fever, chills; Pain at injection site; Headache; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Tremor (L) and (R) hand, arm), VACCINATION SITE PAIN (Pain at injection site), HEADACHE (Headache), ARTHRALGIA (joint pain) and PYREXIA (fever, chills) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site), HEADACHE (Headache) and ARTHRALGIA (joint pain). On 16-Jan-2021, the patient experienced PYREXIA (fever, chills). On 20-Jan-2021, the patient experienced TREMOR (Tremor (L) and (R) hand, arm). The patient was treated with IBUPROFEN at a dose of 1 dosage form; ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 16-Jan-2021, PYREXIA (fever, chills) had resolved. On 19-Jan-2021, VACCINATION SITE PAIN (Pain at injection site), HEADACHE (Headache) and ARTHRALGIA (joint pain) had resolved. At the time of the report, TREMOR (Tremor (L) and (R) hand, arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by reporter.  The patient was under a doctor care for past 6 months for tremors.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Additional information included outcome of the event tremor.
patient got anxious after getting the vaccine. she sat for 5 minutes in the waiting area before acknowledging a team member she is about to faints. she felt dizzy and hit her face/head against the wall.  patient chopped her front teeth. ambulance was called in and she was taken to the hospital to be seen
On approximately 09/12/2000, the patient developed 2 lesions at the injection site and one on her back. Unspecified medical attention was sought. Additional information has been requested.
Right deltoid redness, pain 24 hours after vaccine administration. Prescribed acetaminophen and oral ciprofloxacin 72 hours post injection.
Nausea, headaches, leg pain (04/08 - 04/10) Nonstop headaches, pain in lower right calf (04/08 - Currently)
pt devel nonstop crying for 12 hrs p/1st shots; very irritable; no treatment necessary; no sequelae;
Blood clots developed in lungs. Felt restricted breathing beginning approx. 2 1/2 weeks after 2nd shot. She had an online dr visit and was diagnosed with pneumonia, which appeared to be an error. She took a ZPac for 5 days, but the pain persisted.  She then went to the ER April 9th to learn of blood clots and then found cancer.  It is uncertain if the vaccine played a role, but we are reporting due to the timing.
Case number PHEH2012US009545 is an initial spontaneous report received from a pharmacist on 03 May 2012: This report refers to a patient of unknown age group and gender. This patient was vaccinated with an expired dose of MENVEO (batch number: unknown and expiry date: 30 Apr 2012) intramuscularly on 02 May 2012. No adverse event was reported following this administration error.
2 hours after getting shot, I had rapid heart beating along with fever and fatigue. Then around 8pm I began having a hard time breathing, I could not take full inhalation?s and my throat was swollen.
Narrative: Admission Date: Oct 26,2021 Discharge Date: Nov 12,2021 Condition of patient at discharge: deceased Primary Diagnosis during Admission/Treatment: Acute hypoxemia Respiratory Failure (AHRF) secondary to COVID pneumonia 69 yo male with PMHx significant for ESRD (Dialysis on Tues, Thurs, Saturday), multiple strokes complicated by vascular dementia, IDDM, CAD s/p PCI x2 (2015), PDA s/p SFA angioplasty, HTN, and tobacco abuse presented to the Emergency Department on 10/26/2021 with dyspnea in setting of COVID 19 positive test 10/25/2021 at another healthcare facility. Patient stated he started to develop symptoms of cough, myalgias, and general malaise on 10/23/21 and subsequently tested positive at another healthcare facility 10/25. Decided to come to the ED today for progressive dyspnea following dialysis session. Denied any headache, chest pain, fevers, or sputum production. Patient received 2 doses of Pfizer COVID vaccine on April 1, 2021 and April 22, 2021. In the ER, patient was afebrile, BP 97/53, HR 81, tachypneic to 28, and hypoxic to 86% on room air. Placed on 4LNC and given 500cc IVFs in ED. Labs notable for WBC 4.86 with lymphopenia, BNP 3145, CRP 12.86, D-dimer 16.9, procal 1.11, lactic acid 1.7. CXR with bilateral lung opacities. He was admitted to the ICU with COVID pneumonia, remained on 4L NC overnight satting >90%. ABG 7.5/30.1/59. He was started on dexamethasone on admission (remdesivir contraindicated given renal function). D-dimer elevated, so started moderate heparin dosing at 7500 units SQ Q8H. Procal was 1.11 so started on Zosyn and azithromycin. He received tocilizumab 10/29/21 as described earlier. His oxygen requirements increased to 40L 60% HFNC and the team determined there was possible superimposed bacterial pneumonia as was treated accordingly. After days on HFNC patient began to show signs of respiratory improvement, requiring decreased high-flow settings. Shortly thereafter the patient exhibited symptoms of septic shock requiring two vasopressors and intubation. Patient was not able to be weaned off of mechanical ventilation. Patient's respiratory status was worsened by volume retention in the setting of his HFrEF and chronic ESRD requiring near daily dialysis during ICU stay. On 11/12/2021, A family meeting was held and the decision by the patient's healthcare decision-maker was to transition to comfort care. The patient peacefully passed away on 11/12/2021 AT 8:08PM.
Had cold/flu symptoms including headache, dizziness and dry and scratchy throat  for 7 days.  Took Covid home test 3 days later that was negative.
This spontaneous report as received from a nurse refers to a currently 4 years old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD (dose, frequency and route of administration were not provided) lot# N020011 and expiration date: 13-JAN-2019. The PROQUAD was reconstituted with properly stored dose of sterile diluent (STERILE DILUENT). Data logger was not involved. No adverse event was reported. The vaccine was stored in between 9 degrees Celsius (C) to 25 C for 3 hour and 45 minutes. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1712USA004451: US-009507513-1712USA012874: US-009507513-1712USA012875: US-009507513-1712USA012876: US-009507513-1712USA012877: US-009507513-1712USA012873:
Rash, redness and heat around the injection site 10 minutes after vaccine administered.  5 minutes later  redness and rash started near hairline on forehead and near ears.  Upper lip itchy.  25mg Benadryl given PO, 15 minutes after beginning of reaction.  1hour later another 25mg of Benadryl given when rash persisted and started having a raspy voice.  2 1/2 hrs later the rash was subsiding and hoarsness went away.  Pt. realeased.
Migraines; Swelling in legs, feet, and hands; Severe joint aches; Severe aches; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraines), PERIPHERAL SWELLING (Swelling in legs, feet, and hands), ARTHRALGIA (Severe joint aches), MYALGIA (Severe aches) and NAUSEA (Nausea) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 14-Apr-2021, the patient experienced MIGRAINE (Migraines), PERIPHERAL SWELLING (Swelling in legs, feet, and hands), ARTHRALGIA (Severe joint aches), MYALGIA (Severe aches) and NAUSEA (Nausea). At the time of the report, MIGRAINE (Migraines), PERIPHERAL SWELLING (Swelling in legs, feet, and hands), ARTHRALGIA (Severe joint aches), MYALGIA (Severe aches) and NAUSEA (Nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment medications were not reported.
Noticed soreness left arm after Tdap, awoke me out of sleep, hard to move left arm above head.  Ibuprofen 600 mg 6:30AM, iced after got to work.  9/16 warmth left deltoid to touch, tenderness mid left deltoid, T 97.6.