chrisvoncsefalvay/vaers-outcomes huggingface dataset:
First dose Vivotif taken 7/14/14 AM, awoke during night of 7/14/14 with nausea, headache. Second dose Vivotif taken 7/16/14 AM, rash to shoulders began 7/17/14. Third dose Vivotif taken 7/18/14, progressed to full body rash with itching, hot to touch. No swelling to tongue, throat or difficulty breathing. On morning of 7/19/14, pt awoke to disseminated joint swelling, skin rash diminished. Fourth dose Vivotif taken 7/20/14 - Rash disappeared, joint swelling persisted. On 7/21/14, Pt took 40 mg Prednisone PO. Symptoms improved. On 7/22/14, Pt saw primary care physician for evaluation; Joint swelling much improved.
costochondral soreness and pain, midsternal; left shoulder joint achiness; This is a spontaneous report from a contactable nurse (patient). A female patient of unspecified age received BNT162B2 on 19Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient was having an unusual symptom. She cannot find this symptom in the clinical trials and would like to know if it occurred in the trials. She started having spontaneous costochondral soreness and pain, midsternal, on 27Dec2020, following left shoulder joint achiness on the 24Dec2020 through 26Dec2020. The outcome of the events was unknown.  Information on Lot/batch has been requested.
Severe headache; Feeling unwell; Joint pains; Muscle pains; Difficulty breathing; Chest pain; Tiredness; She felt a "little bit of nausea, very slight"; This is a spontaneous report from a contactable consumer (patient).  A 78-year-old female patient received the first dose of bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot EL3302), via an unspecified route of administration in the left arm on 23Jan2021 11:00 at single dose for Covid-19 immunisation. Medical history included blood pressure abnormal, thyroid disorder and high cholesterol. Concomitant medications included levothyroxine, lisinopril and rosuvastatin. The patient experienced severe headache, feeling unwell, joint pains, muscle pains, difficulty breathing, chest pain, tiredness on 24Jan2021 and little bit of nausea, very slight on unspecified date in Jan2021. The outcome of headache was recovered on 24Jan2021; for difficulty breathing was recovered; for chest pain and fatigue was recovering; for other events was unknown.
Patient had Moderna vaccination on 12/30/2020 at 1010.  Approximately 4 hours after injection reaction were flush face, slight fever, tachycardia (base line 50 reaction rate 97), skin rash on both forearms.  Symptoms lasted about 1 hour. Approximately 4 hours later symptoms of flush face, and fatigue returned. Fatigue and arm pain of 4/10 lasted through 12/31. 1/1/2021 only arm pain remained at 2/10 and lasted an additional 2 days.
pt recvd vax; devel redness,swelling, tenderness at inject site, lasted 2 days
Tenderness at the site of injection, fever, chills, and headache.  All signs and symptoms started about 6 hours after receiving vaccine and lasted about 18 hours.  Felt back to baseline after 36 hours.  Took ibuprophen 400 mg  (morning of the 2/3 and evening of 2/3) for headache with relief and took Nyquil (night of 2/2) for chills and to help sleep with minimal relief.  Symptoms were sever enough that I donot feel like I would have been able to go to work that day.
stiff neck ,cannot turn head side to side, pain at base of skull in back above neck, could not lay down felt like my head was going to explode.
Pt. came in 2/+ pain in L elbow on 8-4-09. Pt relates she had pain and swelling at injection site on 7-21-09 and now the pain and swelling at injection site on 7-21-09 and now the pain is in her elbow.
minor hives on their neck; This spontaneous case was reported by a pharmacist and describes the occurrence of URTICARIA (minor hives on their neck) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included POTASSIUM CITRATE, METRONIDAZOLE and VITAMIN D NOS for an unknown indication.On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 19-Nov-2021 at 12:30 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced URTICARIA (minor hives on their neck). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 25 mg and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at a dose of 10 mg. On 20-Nov-2021, URTICARIA (minor hives on their neck) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.Concomitant drug included calcium supplement (citrate, chloride).
Itchiness on arm of injection; rash on arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness on arm of injection) and RASH (rash on arm of injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced PRURITUS (Itchiness on arm of injection) and RASH (rash on arm of injection). At the time of the report, PRURITUS (Itchiness on arm of injection) and RASH (rash on arm of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medication were provided   Reporter did not allow further contact
Pfizer-BioNTech COVID- 19 Vaccine EUA: During the post-observation period, vaccine recipient reported that they were feeling funny. She stated that she was fine and didnt need to be checked. EMS wanted to be sure and took her to a private area to place her on an EKG monitor. She was experiencing supraventricular tachycardia with heart rates in 170s. EMS placed an IV and administered IV fluids, adenosine 6 mg, and diltiazem 20 mg. Her heart rate went to the 140s and was transported to the emergency department.
Local reaction. 50x50 mm swollen, painful, itchy area with 25x25mm redness. Using symptomatic tx: ADVIL, HC cream, ice.
After receiving vaccination on 5/14/18 the patient was diagnosed with cellulitis and received antibiotic treatment on 5/18/18.
1 of 4 pts vaxed during the last yr (different lots) who exp large hives @ inj site; hives described as red mound-not abscessed, quarter to 1/2 dollar size; This pt required ER visit for tx;
An administration variance was identified regarding his dose.   Initial vial puncture occurred on 02Sept2021 at 12:30 PM and dose was administered to the patient on 03Sept2021 at 8:40 AM.  The vial was continuously refrigerated and did not ever reach room temperature at any time prior to or after puncture.   The patient has not experienced any local or systemic event since administration of his dose.  It has been determined, after communication with Moderna Medical Information, that this variance is unlikely to affect the efficacy of vaccine response.  No additional doses are recommended at this time.
Redness, swollen of left arm around vaccine area - on a 48 hr course. Treatment: BENADRYL 5ml. QHS.
Throat/tongue and neck area swelling for about an hour.  Anxiety and some dizziness. Problem began about half hour after injection then  went away after an hour or so after it began - but my doctor recommended that I do not to get second shot because of this reaction.
got really tired'; chills; diarrhea; she threw up; had swollen lymph nodes; nausea; pain in her arm; This is a spontaneous report from a Pfizer-sponsored program. A 81-years-old contactable female consumer(patient) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number, Expiration date: unknown) via an unspecified route of administration on 28Jan2021 at single dose for COVID-19 Immunization. The patients medical history and concomitant medications were not reported. On 28jan2021, patient experienced some reactions like chills, nausea and diarrhea so was asking if she really needs to take the second dose.  Follow-up information was received on 12Feb2021 from a contactable consumer reported that patient experienced pain in her arm, got really tired', chills, diarrhea, vomiting, and swollen lymph nodes for a little bit. Caller stated that her husband only experienced a sore arm.   Information on the lot/batch number has been requested.
Achy; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy) and FATIGUE (Tiredness) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Achy) and FATIGUE (Tiredness). At the time of the report, PAIN (Achy) and FATIGUE (Tiredness) outcome was unknown.            No concomitant medications were reported.  No treatment information was reported.   This case was linked to MOD21-099585 (Patient Link).
One evening after eating I experienced a lot of pressure in my chest and stomach area. I went to the doctor in late October and got a sonogram of my abdomen and they saw that my gall bladder was inflamed. I had my gall bladder removed on Nov 1st. After my booster, in Dec I experienced pressure in my chest again and I went to ER. I received medication to settle my stomach and morphine. They ran test and saw that my pancreas was inflamed.
pt recv vax & devel an inj site rxn characterized by a 4-inch area of redness, warmth, induration, itching & pain;pt was seen by MD who prescribed keflex & topical hyrocortisone;pt recovered;
Allergic reaction.  Throat tightness and swelling of lips and tongue.    Headache and pressure.
patient was one of several waiting for vaccine. nurse who went to get next patient asked for patient to come to vaccine area. teenager stood up and came to nurse. teenager was not who the nurse called but another pt (Pt 2). Pt 2 was given the original pt's Moderna vaccine. Pharmacist noticed the original pt was still waiting for vaccine. Asked Nurse why the original pt was waiting- and nurse said no that is pt 2 there- and I told nurse no that is pt 1. So pt 2 got MOderna not pfizer. we will follow up with pt in few days. SHe received 0.25 ml of moderna
Hives and itching on left arm from hand up (injection arm). Itching on face, L side. BENADRYL 50 mg PO with relief.
4 weeks after vaccine have developed intense fatigue -- more than normal tiredness. All day but worst in afternoon. I have now heard of 3 other people with similar experiences (all females) so am wondering if this has been documented.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On 01-MAY-2012, a healthcare provider at a medical group administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). On 22-DEC-2014, the patient was treated by a healthcare provider at the same medical group for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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 including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages.  The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
The vaccine given expired past the 30-day recommendations. There have been no s/s of any adverse events at this time
Headache, Sedation, Fever, Chills Narrative:  On the morning of 1/21/21 had onset of fever, chills, extreme fatigue and headache. Symptoms lasted until 1/22/21. Pt was out of work x 1 day. No known prior COVID infection  Other Relevant History:
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown demographics. The patients' concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M036059 with expiry date 03-JUN-2019 (dose and route of administration were not reported) for prophylaxis. The doses were exposed to 51 Fahrenheit (F) for 14 hours 23 minutes. Digital data logger was involved. There was no previous temperature excursion. No adverse effect was reported. Product quality complaint (PQC) was not involved. This is one of 4 reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA014600:US-009507513-1612USA014601: US-009507513-1612USA014599:
Area around inj site sore to touch & red day following injection. Area on (L) lower leg appeared red and itchy at 6 am. Persistent headache.
was administered an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number XH2DF, expiry date 7th May 2022) for prophylaxis.   On 6th June 2022, the patient received the 2nd dose of Shingrix. On 6th June 2022, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK receipt date: 6-June-2022 Reporter's comment: Nurse reported that the patient was administered an expired dose of the Shingrix vaccine. The reporter consented to follow up. Additional Supportive Information: The patient was administered an expired dose of the Shingrix which led to expired vaccine used.
Error resulting in administration of expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Error resulting in administration of expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Error resulting in administration of expired vaccine). On 03-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Error resulting in administration of expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter. No treatment medication reported by reporter.
Patient noticed soreness that began a few hours after receiving the vaccine. The pain went away over night, but she developed a large red area on her upper right arm the following day. Two days after vaccination, patient presented to Urgent Care with extreme redness (4" area) on upper right arm for 2 days after receiving SHINGRIX and was diagnosed with cellulitis. Pus pockets did not appear to be present. She was treated with 7 day course of cephalexin.
Polyps; This is a solicited report based on the information received by Pfizer . (Mfr control no. # 21k-163-3844210-00). A non-contactable consumer (patient) reported a 82-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular on 20Feb2021 at the age of 82-years-old (lot number ddm88) as single dose for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from 2011 (Batch/Lot number was not reported) and ongoing, at 40 mg (40 mg,1 in 2 week) 40mg/0.4ml (40 milligram, solution for injection in pre-filled pen) for crohn's disease. Medical history included abstain from alcohol, prostate cancer (family history father), non-tobacco user, allergies of pollen during springtime manifested by recurrent sinus infection, runny nose. Concomitant medications included carvedilol taken for pacemaker syndrome; memantine taken for pacemaker syndrome. The historical vaccine included 1st dose BNT162B2 (lot number ddm88) on 25Jan2021 at the age of 82-years-old for covid-19 immunization via intramuscular. On 22Mar2021, the patient experienced polyps. In Mar2021, the polyps resolved. Covid-19 vaccine was also considered suspect. On 22Mar2021, he colonoscopy was done colonoscopy where one polyp was found and removed. He had rough time. After a week, in Mar2021 biopsy results came out, polyp removed came back benign.  On an unknown date, an unspecified blood works was no significant findings.  The action taken in response to the event for adalimumab was unknown.  The event outcome was recovered on an specified date in Mar2021.  The reporter's causality for the event of polyps with humira 40mg/0.4ml(adalimumab) was no reasonable possibility.  Abbvie's opinion is that there is no reasonable possibility that the event of polyps to humira 40mg/0.4ml(adalimumab).  The reporter's causality for the event of polyps with covid-19 vaccine was not related.; Sender's Comments: Based on the information currently available,Vaccine BNT162B2  or comirnarity is unrelated to the event polyp.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.
Product given incorrectly.  ADACEL - Tdap was given to a 10 year old.
Caller c/o symptoms starting 3/7/2021 to include fever, nausea, fatigue, & cough. Uses albuterol & ibuprofen as needed. No c/o shortness of breath or chest pain. Keep taking albuterol & ibuprofen, advised to f/u with PCP tomorrow if not feeling any better.
Extreme pain deep in muscular spread to shoulder and NEVER COMPLETELY RESOLVED.  Could not lay on arm.  Was prescribed physical therapy a year later because doctor felt it was rotator cuff issue.  Still feeling discomfort and experiencing limited movement.  D
Rt. leg, Rt. arm weakness. Hemiparesis. Radiating pain down Rt. side. Presented to ER 9/26/10 1 week s/p flu vac. Transferred to another facility for neurology consult.
Intermittent chills and continual fatigue began at 10 PM the evening of the second vaccine dose.  Chills continued intermittently for about 24 hours and fatigue gradually lessened over 80 hours.  Treatment was rest and the occasional acetaminophen tablet.
Hard, red, tender, circular raised welt. Warm to the touch, approx size of a quarter, located at the site of the COVID vaccine injection. Overnight it expanded toward elbow to about 2 inches in diameter with same symptoms/characteristics, plus itchiness. (At this point, the area encompasses both the flu and COVID injection sites.) Approx 48 hours after initial symptoms, the area looks about the same as 24 hours ago, but slightly expanded at the bottom and sides.   Note that 1st and 2nd vaccinations in series were Pfizer and 3rd was Moderna. Mild symptoms (primarily muscle aches & fatigue) following 1st booster / 3rd in series. Sore arm, but no other symptoms at site of injection.
Erythema and edema of (L) upper arm where 2 vaccines were administered. Also has itching.
Information has been received from a nurse concerning a female with diabetes who on 26-JAN-2007 was vaccinated with the second dose of Gardasil (yeast). On 28-JAN-2007 the patient experienced a big knot, redness and puffiness at the injection site. The patient sought medical attention. The patient is recovering from a big knot, redness and puffiness at the injection site. Additional information has been requested.
Hives on neck and swollen submandibular lymph nodes, swelling of left upper and lower eyelid- benadryl taken, swelling resolved within 24 hours
neuromyelitis optica; myelitis; Information has been received from a lawyer refering to a patient of unknown age and gender. On or about 04-OCT-2010, patient was inoculated with a dose of zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) pt suffered myelitis and neuromyelitis optica. As a result of these symptoms, pt was seen and treated by medical providers and is still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, pt's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Pt also experience mental and emotional distress due to resulting physical limitations and seriousness of pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), pt sustained severe and permanent personal injuries. Further, as a tragic consequence of company's wrongful conduct, pt 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 direct and proximate result of company's conduct, pt have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not reported. The events were considered to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, the events of myelitis and neuromyelitis optica were considered to be medically significant. The reporter considered the events to be disabling.
Pressure experienced in bridge of nose and head almost immediately after the vaccine was given. As of submission time patient still experiencing some pressure but having some improvement.  Also experiencing cheek numbness and tingling.  Counseled patient any sign of anaphylactic reaction should go into the ER and if she is experiencing any other reaction to let us know so that they can be reported by us and that she could use online reporting system to also self report
Pt legs (where vaccines given) turned red, arms & face turned red. No diff. breathing, Gave 85 mg Benadryl, Positive response