chrisvoncsefalvay/vaers-outcomes huggingface dataset:
taken to hospital, stayed 7 days, diagnosed with heart               removed significant water, released and feeling well at home. i nearly passed out at doctor's office when it was decided to have an ambulance take me to nearby  Medical Center where i was admitted and treated for 7 days. the diagnosis was  a heart condition with water in my lungs. i never lost consciousness. was treated at night with a CPAC device and was told by the heart,lung and kidney doctor that i made significant progress each day. However, no one could explain after 70 years of no serious (flu) sickness that something suddenly caused my system to fail. At first i thought it might be a function of the COVID shot #2, and it may be.
mild muscle contractions in one leg (left); pain in the site of injection; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 01Apr2021 10:30 (Lot number: ER8134) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "hypothyrodism" (unspecified if ongoing); "Ostopenia" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; ATORVASTATIN; CALCIUM; MAGNESIUM. The following information was reported: MUSCLE CONTRACTIONS INVOLUNTARY (non-serious), outcome "recovered", described as "mild muscle contractions in one leg (left)"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain in the site of injection". The event "mild muscle contractions in one leg (left)" was evaluated at the physician office visit. Additional information: The patient received dose 2 of BNT162B2 (Lot number: EW0172) on 22Apr2021 administered on right arm. The patient had no other vaccine in four weeks. Patient had no COVID prior vaccination and was not COVID tested post vaccination.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021476965 same patient/reporter/event, different vaccine dose
Delta breakthrough infection; Delta breakthrough infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 72 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Undifferentiated connective tissue disease tending", start date: Mar2017 (ongoing), notes: Illness/AE: Undifferentiated connective tissue disease tending towards for me frusta CREST syndrome, Onset Date: Approx. Mar2017, Stop Date (check box if ongoing): Ongoing, Pertinent Details (Include surgical procedures and dates): Mild persistent symptoms including Raynaud's and abnormal esophageal motility; "Toured for me Frusta CREST syndrome", start date: Mar2017 (ongoing), notes: Illness/AE: Undifferentiated connective tissue disease tending towards for me frusta CREST syndrome, Onset Date: Approx. Mar2017, Stop Date (check box if ongoing): Ongoing, Pertinent Details (Include surgical procedures and dates): Mild persistent symptoms including Raynaud's and abnormal esophageal motility; "Raynaud's and abnormal esophageal motility", start date: Mar2017 (ongoing), notes: Illness/AE: Undifferentiated connective tissue disease tending towards for me frusta CREST syndrome, Onset Date: Approx. Mar2017, Stop Date (check box if ongoing): Ongoing, Pertinent Details (Include surgical procedures and dates): Mild persistent symptoms including Raynaud's and abnormal esophageal motility; "Mild persistent symptoms including Raynaud's and abnormal esophageal motility", start date: Mar2017 (ongoing), notes: Illness/AE: Undifferentiated connective tissue disease tending towards for me frusta CREST syndrome, Onset Date: Approx. Mar2017, Stop Date (check box if ongoing): Ongoing, Pertinent Details (Include surgical procedures and dates): Mild persistent symptoms including Raynaud's and abnormal esophageal motility. Concomitant medication(s) included: OMEPRAZOLE taken for gastrooesophageal reflux disease (ongoing); ATIVAN taken for sleep disorder (ongoing); TEMAZEPAM taken for sleep disorder (ongoing). The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 28Jul2021, outcome "recovered" (2021) and all described as "Delta breakthrough infection".  Clinical information:The patient had a Delta breakthrough infection on 28Jul2021. Had mild flu-ish symptoms lasting about 8 days. The patient did not need a doctor hospitalization and seemed to recover without sequelae.Illness/AE: Undifferentiated connective tissue disease tending towards for the patient frusta CREST syndrome Onset Date: Approx. Mar2017. Stop Date (check box if ongoing): Ongoing. Pertinent Details (Include surgical procedures and dates): Mild persistent symptoms including Raynaud's and abnormal esophageal motility.   The lot number for bnt162b2 was not provided and will be requested during follow up.
This patient received the .05 ml invalid Fluzone Quadrivalent, no AE; Fluzone Quad were administered after being exposed to 30 Farenheit, no AE; Initial information received on 11-Aug-2020 regarding an unsolicited valid non-serious case from a other health professional  This case involves a 21 years old female patient who received the .05 ml invalid INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]( lot number not reported and expiration date: Aug-2020), after being exposed to 30 Fahrenheit via unknown route in the left deltoid as prophylactic vaccination on 08-Aug-2020.  Medical history, medical treatment(s), and family history were not provided.  No other medication or vaccinations were received on this visit.   It was an actual medication error case due to product storage error temperature too low.  It was also a case of vaccine underdose.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.
Severe headache, eye pain, noise like raindrops on tin roof, sore joints, trouble breathing, couldn't get full breath, sore throat, flashing white light when moving eyes side to side, 5 days. I thought I was getting a cold or flu but the reactions came on so fast and colds and headaches are something I don't usually get.
Pt recvd vax 18JAN93 & 27JAN93 pt noticed induration, redness, swelling, warmth @ inject site; also devel a low grade fever; sx worsened over the weekend of 30-31JAN93;
pt recv vax 29JAN97 & 30JAN97 pt had a problem w/all parts of body hurting & that pt had excruciating pain when tried to raise both arms;denied any fever or other sx;advised to call MD;
about 6 days p/vax noted red, warm rash on both shoulders @ site of inj;does not hurt or itchy so it could have started 1-2 days prior;no fevers;no rashes elsewhere on body;does not look infected;
The Patient developed Optic Neuritis (headache, loss of vision and color vision in both eyes).  He was ultimately diagnosed with Myelin Oligodendrocyte Glycoprotein Antibody Disease and will be treated either with IV IgG or Rituximab.
No additional AE reported; Administered GARDASIL 9 following a non-supported temperature excursion; This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant therapies, drug reactions and allergies were not provided.  On 03-NOV-2021, the patient was vaccinated with a non-supported temperature excursion (improperly stored dose) (product storage error) of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter, lot number U007652, and expiration date 14-APR-2023 (route of administration was not provided) for prophylaxis. There was no additional adverse event reported. Administered doses of vaccine experienced the temperature excursion of -0.45 degrees Celsius (°C) for 1 hour. There was previous excursions reported of 0 °C for 3 hours.   This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2111USA002695:
Accidentally got a Pfizer COVID-19 vaccine for my third dose; Had fever; Chills; I felt cold; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (I felt cold), EXTRA DOSE ADMINISTERED (Accidentally got a Pfizer COVID-19 vaccine for my third dose), PYREXIA (Had fever) and CHILLS (Chills) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No medical history provided by reporter.  Concomitant products included MIRTAZAPINE (REMERON), CLONAZEPAM, LEVOTHYROXINE, TAMSULOSIN, PANTOPRAZOLE, HYDROCODONE and ROSUVASTATIN for an unknown indication.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced FEELING COLD (I felt cold), PYREXIA (Had fever) and CHILLS (Chills). On 17-Aug-2021, the patient experienced EXTRA DOSE ADMINISTERED (Accidentally got a Pfizer COVID-19 vaccine for my third dose). On 24-Feb-2021, FEELING COLD (I felt cold), PYREXIA (Had fever) and CHILLS (Chills) had resolved. At the time of the report, EXTRA DOSE ADMINISTERED (Accidentally got a Pfizer COVID-19 vaccine for my third dose) outcome was unknown.            Treatment medication were not reported. It was reported that In trying to get a third dose on 17AUG2021, the patient accidentally received a dose of the Pfizer COVID-19 vaccine.   This case was linked to MOD-2021-289789 (Patient Link).
Swollen painful veins in RT leg calf.  Taking prescription of Eliquis.  Pain has gone away.  Swelling is as it was before Covid19 shot.  Will continue Eliquis for 3 months.
Muscle discomfort; Muscle discomfort was reported as worsened.; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 85-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), via an unspecified route of administration, administered in arm left on 05Feb2021 13:15 (at the age of 85 years) as dose number unknown, single for covid-19 immunization. Medical history included ongoing gout. There were no concomitant medications. Prior Vaccinations (within 4 weeks) Patient took pneumonia shot as his doctor recommend this product. On unspecified date of Feb2021 over the weekend the patient experienced muscle discomfort and in the last day or so it has gotten really severe. Patient had muscle discomfort before due to gout but nothing like this. The patient underwent lab tests and procedures which included laboratory test with unknown results on 09Feb2021. The outcome of the events was unknown.     No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
arm was red from her shoulder to her elbow; arm swollen; arm a little itchy; arm tender; This spontaneous case was reported by a nurse and describes the occurrence of ERYTHEMA (arm was red from her shoulder to her elbow), PERIPHERAL SWELLING (arm swollen), PRURITUS (arm a little itchy) and TENDERNESS (arm tender) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure inadequately controlled and Hyperlipidemia (cholesterol).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced ERYTHEMA (arm was red from her shoulder to her elbow), PERIPHERAL SWELLING (arm swollen), PRURITUS (arm a little itchy) and TENDERNESS (arm tender). On 13-Jan-2021, ERYTHEMA (arm was red from her shoulder to her elbow), PERIPHERAL SWELLING (arm swollen), PRURITUS (arm a little itchy) and TENDERNESS (arm tender) had resolved.        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.   Patient reported using medications for Blood pressure and cholesterol concomitantly. Patient took diphenhydramine and ibuprofen for treatment.
Cellulitis at injection site. Around 9pm 1/25/21 noticed redness at site, warm to touch, slight swelling.  Drew outline around it. Next morning  1/26/21 7:10 redness expanded beyond outline. Went to ER.
Mom states had to take pt to ER that evening, because was running fever of 102; was cranky & rt leg swelled a little bit; pt would not take fluids, fluids were given in ER;
Soreness at the site for the first 24 hours; Swelling underneath my right arm; Inflammatory response or immune response from the vaccine; Right breast had swollen areas in it almost being at lymph nodes; Right breast had swollen areas in it almost being at lymph nodes; Around nipple was very swollen and had about three knots; This is a spontaneous report from a contactable Nurse (patient). A 34-year-old female patient received first dose of BNT162B2 (lot number not provided), via an unspecified route of administration on an unspecified date at single dose for COVID -19 immunization. Medical history and concomitant medication were reported as none. The nurse stated she had received the first dose of the Pfizer Covid Vaccine on Thursday. It didn't really had anything other than some soreness at the site for the first 24 hours but on the Saturday, she started noticing a bit of swelling like underneath her right arm. She didn't think anything of like that was probably just the inflammatory response or immune response from the vaccine. So, she thought it was all a normal side effect. The next morning, next Sunday morning, she woke up and her right breast had swollen areas in it almost being at lymph nodes and that's kind of where she just thought - Okay the breasts have lymph drainage and vessels and all these things. And she could palpate it like from her arm pits, she could palpate and can find out another one that was the area but it was around her nipple that was the concern because it was very swollen and had about three knots and again she was like probably it's just the lymph nodes. She reported "But they wanted us to report anything. You are at Hospital, like little health area and I was told that you need to call Pfizer too. I am saying that is something out of the ordinary because I am like they are not ordinary, they are in the breast area.  don't want to call it as nothing, it might be something else as it is kind of hard to tell if it related to the vaccine or is it not or something I need to talk to my OB-GYN about. I didn't know if that was something else did anybody else is experiencing". The event onset date was unspecified. The treatment of the events included Motrin. The outcome of the events was unknown.  Information on the Batch/Lot number has been requested.
After receiving vaxs, child started to complain of discomfort. On 1/12, child's temp was elevated. Child also complained of sore throat & knot on arm. Pt was seen and dxed w/ flu.
Pt exp malaise & joint pain following vax w/Hep B vax; no further details were provided;
Patient given Moderna vaccine 12 hours after vial was opened 5/14/2021 @ 10:06 AM. Followed up with patient on 5/17/2021 @ 2:45 pm via telephone. Patient stated she has not had any adverse reactions or allergic reactions to vaccine. Patient states she is feeling fine.
localized swelling; localized swelling and redness; This non-serious case was reported by a nurse via sales rep and described the occurrence of local swelling in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced local swelling (Verbatim: localized swelling) and localized erythema (Verbatim: localized swelling and redness). The outcome of the local swelling and localized erythema were not reported.   It was unknown if the reporter considered the local swelling and localized erythema to be related to Shingrix.     It was unknown if the company considered the local swelling and localized erythema to be related to Shingrix.   Additional Information: GSK receipt date: 6-JUN-2023 The reporter was a field staff employee. The nurse reported that the patient had dose of Shingrix, did not receive 2nd dose. The patient had localized reaction to first dose of Shingrix immunization that was localized swelling and redness. The reporter consented to follow up.
Onset of dyspnea, leading to lightheadedness and fall resulting in low back contusions. Also chest pain with the dyspnea.
Cannot use her right arm (worsening arm pain); A spontaneous report was received from a consumer concerning a 58-year-old, female patient, who received Moderna's COVID-19 Vaccine and experienced can't use right arm, arm begin to sore and was getting worse.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, Wednesday at 8 AM, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (Batch number: 025L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 30 Dec 2020, Wednesday the patient experienced can't use right arm, arm begin to sore and was getting worse.  Treatment for event can't use right arm, arm begin to sore and was getting worse included muscle relaxant, heat-ice pack, pain medication and acetylsalicylic acid.  Action taken with mRNA-1273 in response to the event can't use right arm, arm begin to sore and was getting worse was not reported.  The outcome of the event can't use right arm, arm begin to sore and was getting worse was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
No patients experienced any adverse effects; Improperly stored dose of ROTATEQ; This spontaneous report was received from a physician concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, or drug reactions/allergies.     On 28-APR-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) vial (product storage error), by oral route (lot # 1660693, has been verified to be a valid lot number; expiration date 19-MAR-2021) as prophylaxis (dosage schedule and strength were not reported).   The administered dose of the vaccine experienced a multiple temperature excursions below highest temperature above 47 Fahrenheit degrees  to 66.6 Fahrenheit degrees for 2 hours and lowest temperature below 36 Fahrenheit degrees to 33.6 Fahrenheit degrees  for 45 minutes as recorded by a data logger. There was no previous temperature excursion. There was no adverse effect reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA001703:
I experienced a lot of fatigue and soreness & irritation in my arm for 3 to 5 days. Pockets of blood developed on my right forearm called Purpura. I had these bright red blotches type of rash under the skin of my right arm. Recently, I've been dealing with a fever, congestion, cough, sore throat, and headache. I was diagnosed with strep C. I tested negative for COVID-19 multiple times.
Have a small pus filler blister at injection site . Around blister is red swelling and mark.
Fever chills myalgias rendess and swelling left deltoid - unable to move left shoulder due to pain.
Brain feels foggy or groggy, as if I am depressed, or really tired, no matter if I get enough sleep or not. Have not been able to attain or maintain an erection in two weeks, my sex drive is 100% dead. I used to have an extremely strong sex drive until 2 weeks ago. Something is very, very wrong with me.
Initial report was received from a consumer on 11 December 2012. About ten unidentified patients had received an injection of FLUZONE Vaccine, Sanofi Pasteur (lot number, route, site and date of administration not reported) and about three to four weeks following vaccination had "the flu". Each patient tested positive for either type A or B flu strain. No additional information was provided. Outcome was not reported. Documents held by sender: None.
Systemic: Seizure-Mild, Additional Details: Patient Experienced seizure immediately after receiving vaccine. Last only a few seconds. patient had no loss of memory or any other problems
This spontaneous case reported by a consumer, describes the occurrence of hypoesthesia (face went numb) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 040C21A) for COVID-19 immunization. No medical history reported. On Aug 7, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Aug 7, 2021, patient experienced hypoesthesia (face went numb). On Aug 10, 2021, hypoesthesia (face went numb): resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided.
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 22-JAN-2010, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended by her physician for the long-term prevention of shingles and as a preventative measure prior to having surgery. The ZOSTAVAX did not prevent shingles as intended. Instead, the patient contracted a persistent strain of shingles, or herpes zoster. On approximately 19-MAY-2011, the patient was treated by a physician for the onset of herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the defective ZOSTAVAX, 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, pain and suffering, and other damages. Additional information has been requested.
Allergic reaction of hives for over 7 days after second vaccine on legs arms and face swelling
On 2/3/21 I received my 1st dose of the Moderna vaccine to my left arm, and after a few days I didn't feel much soreness, but after receiving the 2nd dose which was received on 3/5/21 to my right arm, I am experiencing soreness in BOTH arms.
Red area 5cmx3.5cm, slightly raised and hot over deltoid muscle. Started 48 hrs. after vax. Pain more over inject. site, but radiates down rt arm & up into neck. Tx:Ice pk. today. Ice & heat after today. Ibuprofen 200mg, 2-3 tab. every 6 hr
fever, lethargy; shallow breathing pt would not walk started w/in 24 hr of vax; leukocytosis of 20,000 & neck stiffness; pt recv ATB
Administered vacs; 2 days later erythema rapidly spreading, raised, non itchy, extrem. and trunk. Noted 10cm purple ring at site of Prevnar injection with erythematous borders.