chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme pain in both arms to a point I could not lift them. Low Grade fever of 2-3 degrees, headache, body ache, muscle weakness and cramps, dry mouth, nausea, constipation. Not able to perform any activity because of weakness and fatigue. The early reactions also caused sinus congestion, chest congestion, and asthma like symptoms. These passed after about 14 hours. I contacted the pharmacist after 24 hours and she told me I could take Aleeve. I did this, and within about 2 more hours, started feeling relief of symptoms. About 30 hours after the injection, all symptoms were gone except soreness at the injection site.
Narrative: Patient received two doses COVID 19 vaccine Mar/Apr 21. Patient tested positive for COVID 19 on 7 September 2021 and was hospitalized due to respiratory failure, fever, and COVID pneumonia. The patient received treatment and stable and was discharged on 15 September 2021. The EUA requires patients that received the vaccine and developed COVID 19  that result in hospitalization or death are reported.
This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 11-SEP-2014,t he patient was vaccinated with the second dose of ZOSTAVAX (dose, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. Medical assistant reported that patient received ZOSTAVAX on 24-JUL-2013. Patient inadvertently received a second ZOSTAVAX on 11-SEP-2014. No adverse effects were noted. Additional information has been requested.
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Systemic: Visual Changes/Disturbances-Mild
trigeminal herpes zoster; Information has been received from a lawyer and a female patient of unknown age regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider at a physician office for trigeminal herpes zoster. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Painful sores on two toes of the right foot.  Round raised bumps that are purple and painful.
common cold; tested positive for COVID-19; sore throat; lost her smell and taste; lost her smell and taste; Little bit of shortness of breath; stuffy; Slight headache; her sinuses were clogged; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 03Apr2021 09:25 (Lot Number: ER8733; Expiration Date: 31Jul2021) as SINGLE DOSE for COVID-19 immunisation. Medical history was reported as none. The patient recently tested positive for COVID-19 on 12Apr2021, a "few weeks" after getting the first dose of the COVID-19 vaccine. She asked when to get the second dose of the COVID-19 vaccine. The patient originally had a sore throat that has gone away. Then she became stuffy, then lost her smell and taste. She has a little bit of shortness of breath if she was up moving around and a slight headache here and there. The sore throat started on 08Apr2021 and lasted for a few days. Once that went away she started to have other symptoms that were more recent. She only had sore throat for 2 days. The stuffiness probably started around 10Apr2021, she isn't sure. She lost her smell and taste around 09Apr2021 or 10Apr2021, around the same time she had the stuffiness. She can kind of smell some things but only if it's right under her nose and it still isn't that strong. Her taste has been pretty much the same. She can only taste little bits of things. She noticed she can taste pickles but not much else. The shortness of breath started when she got the stuffiness and her sinuses were clogged and she couldn't breathe, so around 09Apr2021 or 10Apr2021. It is a little better but still around the same. It is not that much better than it was before. She doesn't know when the headache started, around the same time as the stuffiness. It happens when she is moving her eyes around. It is on and off. She had one yesterday and has a slight one today. She takes birth control but she doesn't think that is relevant. Prior to vaccination, the patient was not diagnosed with COVID-19. The events did not result in emergency room or physician office visit. The outcome of the event sore thorat was recovered on 10Apr2021. The outcome of the event lost smell and shortness of breath was recovering. The outcome of the event lost taste, stuffy and headache was not recovered. The outcome of the rest of the events was unknown.
This is a spontaneous report from a nurse referring to a 59 year old male who, on 5/27/1999, received his 1st Lymerix shot and several hours later, he experienced nausea for several hours. The symptoms resolved on the same day. The most recent information, received on 8/20/99, reports the condition of the pt as resolved.
sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 06Jun2022 at 10:00 as dose 4 (booster), single (Lot number: FK9893) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 1, Lot EM9810), administration date: 04Feb2021, for COVID-19 Immunization; BNT162b2 (Dose: 2, Lot EN6200), administration date: 24Feb2021, for COVID-19 Immunization; BNT162b2 (Dose: 3/1st booster, Lot FF2589), administration date: 08Oct2021, for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 07Jun2022, outcome "unknown", described as "sore arm".  Additional Information: Wife of patient reported for patient. It was reported that the agent relayed she had a caller on the line reporting her experience with second booster dose of the Pfizer COVID-19 vaccine and knew couples that had the same experience as she had. Agent relayed it was given on Monday and yesterday her husband had a sore arm, and she was in bed all day, she felt like she had the flu or something. Agent relayed the caller mentioned that that was not unusual as it happened with a couple of her friends. Agent relayed the callers husband weighed 210 pounds and the caller was 126 pounds. Agent stated the caller provided weights as she had a question about why the dose for the Pfizer COVID 19 vaccine was not adjusted for weight and that she addressed that. Agent relayed the caller mentioned that her symptoms were much worse outcome than her husband. Agent relayed the caller stated they are both 75-year-old and in relatively good health for 75. The Caller stated her husband did not even have any reaction other than the sore arm and she read online that a reaction means it was working and it was a good thing, and she was wondering did that mean he need another booster. Caller stated her and her husband both got the same injection, the guy pulled it up withheld and they did not report their weight. Caller stated when she said her husbands arm is sore, it was no worse than a flu shot and was not out of the ordinary. Caller stated they got their other doses at their doctor office, but they do not do them anymore. Caller declined to report for her husband or her friends. Caller asked if the dose for the Pfizer COVID-19 vaccine was adjusted for weight, and if not, why were not they "because other prescriptions and med tend to be somewhat adjusted for weight". Caller was concerned and "felt like she had much worse outcome than her husband is because caller is very much smaller than him". Caller also added that "her husband is twice her size" and it "doesn't make sense that they both received the same dosage". Caller complained on why there was no dosage adjusted based on age for the Pfizer COVID-19 vaccine. Caller stated that it did not make sense that "her husband who is twice her size would be given the same dose as her". Investigations were not provided.
I started experiencing severe inflammatory acne, sometimes cystic, following this time. It got much worse following my third dose on Dec 17, 2021. (Second dose was May 1, 2021). Still ongoing, though am receiving topical steroids and antibiotics for it.
ACTHIB product was reconstituted with 0.7ml of sterile water and administered with no AE; Initial information regarding an unsolicited valid non-serious case was received from other health care professional and physician via Agency (Reference number - 00898182) and transmitted to Sanofi on 14-Dec-2021.  This case is linked to case 2021SA421272 (same reporter).  This case involves 1 year old male patient administered HIB (PRP/T) VACCINE [ACT-HIB] product was reconstituted with 0.7ml of sterile water (product preparation error).  Relevant medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination.  On 14-Dec-2021, the patient received fourth 0.5ml total dose of suspect HIB (PRP/T) VACCINE (lot: UJ636AAA and expiry date: 26-Feb-2023) (Frequency = once) (Strength = standard) (Dosage form : Single dose Vials) via unknown route in the left thigh for prophylactic vaccination and product was reconstituted with 0.7ml of sterile water (product preparation error).  It was reported "Caller would like to know if the dose is valid? Caller would also like to know how soon should they repeat the dose? No further information provided by the reporter".  This case was an actual medication error due to wrong solution used in drug reconstitution (latency: same day).  At the time of reporting, no adverse event.  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 the 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.
This spontaneous report as received from a healthcare professional refers to a 9 month old patient of an unknown gender. On 03-DEC-2014 the patient was vaccinated with a dose of VAQTA, dose of 0.5 ml (route, lot number and expiration date not reported). No adverse effects were reported. Additional information has been requested.
2 weeks after the second shot my hearing got super sensitive and that became headaches that persist. I have also have a hard time keeping an erection that is completely new to me.
Patient reported the localized area was swollen, red, hot to the touch and was itching.  No problems with movement and no fever.  Advised cool compress and Benadryl as needed.
Woke up the day after getting my COVID booster shot with the symptoms of: fatigue, muscle aches, headache, congestion. Symptoms lasted between 12-24 hours.
hives; it's itching; like a rash in the arm; red, 3 or 2 inches, large area of red spots, its around the area of the vaccine shot and goes down the direction of the shoulder; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), PRURITUS (it's itching), RASH (like a rash in the arm) and VACCINATION SITE ERYTHEMA (red, 3 or 2 inches, large area of red spots, its around the area of the vaccine shot and goes down the direction of the shoulder) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jul-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 URTICARIA (hives), PRURITUS (it's itching), RASH (like a rash in the arm) and VACCINATION SITE ERYTHEMA (red, 3 or 2 inches, large area of red spots, its around the area of the vaccine shot and goes down the direction of the shoulder). At the time of the report, URTICARIA (hives), PRURITUS (it's itching), RASH (like a rash in the arm) and VACCINATION SITE ERYTHEMA (red, 3 or 2 inches, large area of red spots, its around the area of the vaccine shot and goes down the direction of the shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment information was provided.   Reporter did not allow further contact
Patient presented to the ED, intoxicated, reporting suicidal ideation. Patient was admitted to Behavioral Health unit for safety and stabilization. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
Headache started on 3/24/21.  Two days later, patient experienced facial droop.  Told to go to ER.  Of note, patient reports childhood history of polio.
Information has been received from the authors of the published literature abstract, regarding to a patient of unknown age and gender who on an unknown date, was vaccinated with a dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (manufacturer unknown) (lot # and expiry date were not reported). On an unknown date, the patient was confirmed to have small fiber neuropathy (SFN) by history, clinical exam and low intra-epidermal nerve fiber density (INFD). No involvement of the large fiber was confirmed by clinical exam and electrophysiological tests. Possible triggering factors were identified to be Human Papilloma Virus (HPV) vaccination in one patient. At the time of reporting the outcome of small fiber neuropathy was unknown. The reporter considered small fiber neuropathy to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (manufacturer unknown). Additional information has been requested.
While receiving the flu shot I felt my muscle shaking. Almost immediately my muscle started to hurt. I know that this is pretty common and would go away after a few days. I am now over 3 weeks from having the shot and my arm is still so sore its painful to lift it. I am so afraid some damage was done. I don't know what to do to alleviate the pain and what to do to fix it.
Hardness of skin. Itching. Growing redness. Pain. Swelling. Started within a few hours of time of injection in Monday. Symptoms are worse today on Friday.
Ramsey Hunt Syndrome; Bell's palsy; Shingles in ear; Trigeminal neuralgi; Information has been received from a lawyer regarding a case in litigation, concerning a female patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not reported.   On 22-SEP-2009, the pt was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose of prevention of shingles (herpes zoster) (dose, route of administration, anatomical location, lot number and expiration date were not reported).   On an unspecified date and as a result of vaccination, the pt suffered shingles in her ear, Ramsey Hunt syndrome, Bell's palsy and trigeminal neuralgia, which resulted in severe injuries including pain, hearing and balance problems, facial paralysis which caused one eye to close, and problems with eating and drinking and other ordinary functions. The pt's symptoms have resulted in physical limitations not present prior to using the vaccine; she also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. The pt sustained severe and permanent personal and emotional injuries and loss of consortium. Further, she suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a result of the pt's injuries, her husband has suffered loss of services and society and asserts a loss of consortium claim.   The reporter stated that these injuries were caused by zoster vaccine live (ZOSTAVAX) and were continued by the time of this report.   Upon internal review, Ramsey Hunt syndrome and Bell's palsy were considered to be medically significant event. Moreover, all the reported events were considered to be disabling,
Injection given IM in patient's  L  deltoid. EUA distributed to patient per CDC regulations.  Lot # 011J20A Manufactured by Moderna  Patient filled out COVID 19 Immunization Screening and Consent Form.                   Pt presented to clinic 1/9/2021 for first dose of Moderna COVID-19 vaccine. 10-12 mins post vaccine pt began to feel warm/dizzy. Pt experienced a brief episode of syncope, shortly after pt regained consciousness , and then experienced 1 episode of emesis Pt was alert, reported hx of vasovagal type sx's, She was given juice, took Midodrine, and given IV Sodium Chloride 0.9% VSS Pt then reported feeling fast heart rate, EKG done w/ NSR Pt began to experience body tremors, HR 109, BP WNL EpiPen administered at 10:58 a.m.  per provider's order Pt reports subjective tongue swelling , Second dose of Epi given 11:08a.m. Pt transported to Hospital via ambulance
arm pain/lasted 3-4 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain/lasted 3-4 days) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm pain/lasted 3-4 days). At the time of the report, PAIN IN EXTREMITY (arm pain/lasted 3-4 days) 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.   Concomitant medications were not provided.  Treatment information was not provided.
passing out, temporally loss of speech, shortness of breath, inability to open eyes, lack of oxygen,  Last about 30 to 45 minutes. Head and face vigorously showered with cold water, pain like chest pain
Patient presented to the pharmacy on 9/19/19.  She said that after she got the shingrix shot on 9/12/19 her arm was very sore, but 3-4 days after she developed a roughly 4 inch by 3 inch warm, "tight feeling",  red splotch on her left arm, about 4 inches below the injection site.  Upon looking at it on 9/19/19, it does not appear to be raised, or a rash, and patient reports it does not itch. She says it is still tender to the touch, but the arm pain has improved.  She reports no other symptoms, it appears to be local to that one red area.
Person had the first dose of Pfizer vaccine and now have Parkinson's; This is a spontaneous report from a non-contactable consumer reported that a patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the first dose of Pfizer vaccine and now have Parkinson's (unspecified date). The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
After about a half an hour (on the way home), I noticed my left arm was tingling from the elbow down. By day two, both my arms and legs in their entirety and the lower lower right side of my face were tingling. My ears were ringing a lot more than usual. My husband said I looked pale, I called my PCP on 3/15/21. His nurse relayed the message that this should go away in 2-3 days/ It didn't/ IT got much worse. By day 3 my entire arms and legs had gone numb. I have weird burning sensations in my insides that come and go. Now after 5 + weeks, I'm beginning to get occasional cramps in my legs. At times my hands and feet are very cold. I feel pain in my hands and feet. It doesn't feel like it's getting better. It feels like it is getting worse. It's worse at night with extra tingling and it's hard to get to sleep. I've had ongoing discussions about these reactions with various pharmacists at the pharmacy both via email and by phone.
I am a 74 year old male in good health with NO prior reactions to the annual flu, pneumonia, or shingles vaccinations.  Because of a scheduled prostate biopsy in early April 2021, I wanted to complete the vaccination for COVID-19 in advance of this procedure.   Within 5 mins of receiving the vaccination shot in my left arm, my left elbow and forearm began to swell into a large ball shape near the elbow joint.  At the same time, my left hand became noticeably swollen as well.  Fortunately, I did not experience trouble breathing or have any numbness in my fingers at that time.  The observation staff nurses took me to a separate room to check my blood pressure and heart rate which were both in the normal range.
Dermal reaction, redness , warmth, headache. Body Aches.   Has taken 2 Tylenol for headache.  Cannot take Benadryl due to work schedule. Recommend following up with a phone call to HCP.
headache; nauseous; tired; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), NAUSEA (nauseous) and FATIGUE (tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Migraine (migraines.).   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced HEADACHE (headache), NAUSEA (nauseous) and FATIGUE (tired). At the time of the report, HEADACHE (headache), NAUSEA (nauseous) and FATIGUE (tired) outcome was unknown. Not Provided          No concomitant medications were provided.  No treatment medications were provided.  Action taken with mRNA-1273 in response to the events was not Applicable.