chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered pharmacist concerning a 77 year old female patient with no medical history or allergies who had 2 previous outbreaks of shingles. the patient was vaccinated with ZOSTAVAX vaccine (Merck) (lot # 6649091/0140Y) SC on 16-APR-2009. The patient developed shingles for the third time after receiving ZOSTAVAX vaccine (Merck) on 17-APR-2009. This shingles outbreak was on the left side of the patient's face, jaw and mouth. The patient reported to the registered pharmacist that this was a milder outbreak than she had had in the past. The patient had made a phone call fro medical attention. At the time of reporting the patient was recovering from the shingles on the left side of the patient's face, jaw and mouth. Additional information has been requested.
clavicular nodules; This is a spontaneous report received from non-contactable reporter(s) (Physician) from a sales representative.  An adult patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NODULE (non-serious), outcome "unknown", described as "clavicular nodules".  Additional information: dose received more than 3.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Adverse event: Right after shot - swelling of eyes, lips, throat - same symptoms as first three Pfizer COVID shots but not as severe as the current Moderna shot; 40 minutes after shot - severe swelling of throat, severe coughing spells, wheezing, chest compression, total loss of voice. Treatment: self-administered antihistamine hour before shot,  self-administered liquid benadryl at clinic after initial reaction to shot, albuterol in ambulance, pepcid at hospital, sodium chloride at hospital, Robitussin and more benadryl offered at hospital refused since symptoms were subsiding, prednisone for two days after discharge. Outcomes: symptoms of vaccine reaction subsided after treatment, no symptoms for COVID were noted before or after incident, referral to hospital outpatient COVID Treatment Center
Bad outbreak; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Bad outbreak) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Bad outbreak). The patient was treated with PREDNISONE for Vaccination site reaction, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (Bad outbreak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   This case was linked to MOD-2021-032203, MOD-2021-032000, MOD-2021-032203 (Patient Link).
Swelling of fingers; Few mildly itchy hives on the arms; Mild fever; Achiness; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling of fingers), URTICARIA (Few mildly itchy hives on the arms), PYREXIA (Mild fever), MYALGIA (Achiness) and FATIGUE (Fatigue) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M21A, 026D21A, 029120A and 039K20A) for COVID-19 vaccination.     Patient had not test or diagnosis with COVID-19.  Previously administered products included for Product used for unknown indication: SHINGRIX. Past adverse reactions to the above products included Allergic reaction with SHINGRIX.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2022, the patient experienced PERIPHERAL SWELLING (Swelling of fingers), URTICARIA (Few mildly itchy hives on the arms), PYREXIA (Mild fever), MYALGIA (Achiness) and FATIGUE (Fatigue). At the time of the report, PERIPHERAL SWELLING (Swelling of fingers), URTICARIA (Few mildly itchy hives on the arms), PYREXIA (Mild fever), MYALGIA (Achiness) and FATIGUE (Fatigue) outcome was unknown.            Patient states concomitant medication included number of things.  Patient did not receive treatment.
Pt recvd 3 doses of Engerix-B; titer checked 7 months p/3rd dose; titer result was a low pos result;
Patient started experiencing swelling in the arm, temperature, chest pain, shakiness and dizziness, and difficultly breathing later that evening. Patient went to emergency room where they treated for an allergic reaction.
Caller has experienced hair loss; hair on his head right now comes out; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2, solution for injection), administration date 22Jan2021 (Lot number: EL3246) at the age of 67 years as dose 1, single, administration date 12Feb2021 (Lot number: EL9269) as dose 2, single and administration date 10Oct2021 (Lot number: 30130819) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious) with onset 2021, outcome "not recovered", described as "Caller has experienced hair loss"; HAIR DISORDER (non-serious) with onset 2021, outcome "not recovered", described as "hair on his head right now comes out".  Additional information: Patient reported his AE after hours to and wants to ask this question. He knows of 7 people who have lost hair. Has had all 3 doses of Pfizer Covid vaccine patient has experienced hair loss, is this a normal side effect Spoke to the caller from the attached document. Medical Inquiry (v12.0) DOC-Withheld/ 20Apr2021 No information found regarding product medical question. hair loss is currently ongoing, and it is not just losing his hair but the hair on his head right now comes out since the vaccine and the hair is very limp and fine and like baby hair. Dates for hair loss is currently ongoing and it is not just losing his hair but the hair on his head right now comes out since the vaccine and the hair is very limp and fine and like baby hair was unspecified. Reporter seriousness for hair loss is currently ongoing and it is not just losing his hair but the hair on his head right now comes out since the vaccine and the hair is very limp and fine and like baby hair was Unspecified. Caller states he is calling about the Pfizer COVID Vaccine and states he does not know if Pfizer has heard of any of this, but he knows seven people off the top of his head that are losing their hair since they had the vaccine and states he also is losing his hear after having had the vaccine and wanted to know if this is related to the vaccine. Reporter states he does not think he has previously filed this or does not know who he spoke with but states he did go through all of these questions before and had spoken with someone who was difficult to understand with a heavy accent and after he finished speaking with the agent was informed that was closed at that time, and he has called back regarding his question, Caller states he has no report reference number to provide and caller was asked for patient information and vaccine information related to the seven patients and did not provide this information at this time; as the caller stated he previously did go through all of these questions in the initial call, this report is filed as follow up. Caller declined to provide email address. States his legal name is withheld on his patient card.  Follow-up attempts are completed. No further information is expected.
Feel terrible; This case was reported by a consumer via call center representative and described the occurrence of feeling bad in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was not recovered/not resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingrix.  Additional case details were reported as follows: The age group was not reported but was selected as an adult as per vaccine indication. The patient received Shingix and felt terrible.  The reporter asked what could be done to feel better. The reporter did not had additional information.
Red Rash at injection site 6 days after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red Rash at injection site 6 days after vaccination) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01CA21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included SPIRONOLACTONE for an unknown indication.    On 23-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced RASH ERYTHEMATOUS (Red Rash at injection site 6 days after vaccination). At the time of the report, RASH ERYTHEMATOUS (Red Rash at injection site 6 days after vaccination) outcome was unknown. Not Provided
Chills, mild fever, joint aches, skin sensitivity. Fatigue but difficulty sleeping. Similar to onset of flu, but milder.
Chronic leg pain.  ? First complain my have preceded (9/7/05) but increased over past 4 checks.
Presented to the ED due to 2 week history of generalized malaise and weakness, shortness of breath and COVID-19 diagnosis and 1 day history of fevers and chills.  Denies any nausea, vomiting, chest pain, palpitations, lightheadedness or dizziness.  No exacerbating or alleviating factors. ED workup significant for tachycardia, tachypnea, fever 101.3° (on admission, although T-max 104.1°), hypoxia 85% on room air. - chest x-ray with bilateral opacities consistent with bilateral pneumonia - CT chest/abdomen with bilateral ground-glass opacities consistent with bilateral viral pneumonia.  Pt vaccinated with Pfizer 07/06/2021, 07/27/2021.  Discharged from the hospital 4/10/22
11/7/18 Returns for #2 TWINRIX. Reports that mid morning on 10/29/18 during a meeting at work, began to feel flushed and a rash appeared starting at chest and moved up, but was most prevalent in chest area. The rash then proceeded to move all over her body. States rash was even into the genital area and did also cover legs and arms. Felt feverish but did not take temperature but definitely felt warm for a day or two. Was very itching and describes as red raised rash. Symptoms lasted for four days and then recovered fully.
DYING FROM THE SEVERITY OF THE PAIN; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced dying from the severity of the pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dying from the severity of the pain. This report was non-serious.
This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Slight warmth), NIGHT SWEATS (Sweating at night), PARAESTHESIA (Tingling in skin), HUNGER (feeling of hunger) and JOINT STIFFNESS (joint stiffness) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, the patient experienced FEELING HOT (Slight warmth), PARAESTHESIA (Tingling in skin), MYALGIA (soreness/body aches/hurt when he walked or anytime he was upright stating using a muscle or nerve was sensitive/body aches/muscle sensitivity) and PYREXIA (Fever). 03-May-2021, the patient experienced ARTHRALGIA (Joint pain) and FATIGUE (Tired/ fatigued/took everything out of him). On an unknown date, the patient experienced NIGHT SWEATS (Sweating at night), HUNGER (feeling of hunger), JOINT STIFFNESS (joint stiffness), MICTURITION DISORDER (constant feeling of needing the bathroom), DECREASED APPETITE (Loss of appetite and taste for certain foods), AGEUSIA (Loss of appetite and taste for certain foods), TEMPERATURE REGULATION DISORDER (temperature disregulation) and HEADACHE (Headache). The patient was treated with ACETAMINOPHEN for Fever, Headache, Ache, Temperature regulation disorder NOS, Joint stiffness and Fatigue, at an unspecified dose and frequency. On 12-May-2021, PARAESTHESIA (Tingling in skin), FATIGUE (Tired/ fatigued/took everything out of him), MYALGIA (soreness/body aches/hurt when he walked or anytime he was upright stating using a muscle or nerve was sensitive/body aches/muscle sensitivity) and PYREXIA (Fever) had resolved. At the time of the report, FEELING HOT (Slight warmth), HUNGER (feeling of hunger), JOINT STIFFNESS (joint stiffness), MICTURITION DISORDER (constant feeling of needing the bathroom), DECREASED APPETITE (Loss of appetite and taste for certain foods), AGEUSIA (Loss of appetite and taste for certain foods), TEMPERATURE REGULATION DISORDER (temperature disregulation), ARTHRALGIA (Joint pain) and HEADACHE (Headache) outcome was unknown and NIGHT SWEATS (Sweating at night) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.4 (High) High. On an unknown date, Influenza virus test: negative (Negative) Flu A/B rapid test negative. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative by both PCR and rapid test. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. This case was linked to MOD-2021-200716. Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Patient demographics added. Vaccination date added. Few events onset date and end date added. Treatment medication updated.
Provider ordered DTaP (DAPTACEL) and HIB (ACTHIB) vaccines for the 15 month physical exam. Medical assistant accidently administered QUADRACEL (DTaP and Polio) along with the HIB vaccine.
Mom noticed left arm swelling the evening of 11/6/18, drew circle around, noted today (11/7/18) spreading beyond pen marks, appears like welts, hot to touch, and very itchy. Oral BENADRYL.
Teeth sensitivity, front teeth. It feels like a similiar sensation to using strong Crest Whitestrips daily. Teeth are sensitive to inhaling via mouth and sensitive to drinking room temperature water of about 75 degrees.
Post vax, pt returned to office on 10/4/00 with local signs and symptoms of cellulitis of the right arm.
Shingles developed on my left lower back and torso approximately three month after receiving the Covid-19 vaccine.
PEr mother, about 4 hours after injectiopn, he developed a fine maculo-papular rash in feet and legs, later extending to torso and extremities. Minimal edema of ankles, and in area covered by socks rash was confluent. Pt was examined the next day, rash present, worse in LE, less in upper body. Blanches to pressure. Rest of exam wnl.
On 11/10/22 in the evening, I started to feel pain under my left and right armpits. Initially, I thought it was due to my bra, but the pain increased as time went on. I checked for lumps under both arms and researched side effects of the vaccine booster. It read that swollen lymph nodes are uncommon and could last for 10 days. I've had no reactions from the previous 3 Pfizer shots, but this one was itchy at the injection site hours later, and now I'm assuming my lymph nodes are swollen. It's either that or I'm scared I have cancer now (which does not run in my family). I also read that the effect is usually on the side where the injection was performed. In my case, it was both sides which prompted me to report this to you.   As of today, 11/11/22, my right armpit is slightly less painful than the left side (injection was left arm), but the left armpit pain is still the same as last night.
This spontaneous report as received from a nurse refers to a 10 months 28 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) liquid PEDVAXHIB (injection, lot # K016965, exp date: 20-JUL-201)(dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Immediately, post vax, became upset and saying "I'm gonna be sick". Cold, wet washcloth was applied to throat. She was pale, diaphoretic, BP 90/60, pulse 80. Transferred to hallway and laid down on exam table with feet elevated. BP 88/60, pulse 82, resp 16 and non-labored. Temp 97.9F. She remains pale, but is now shivering. Took a few small sips of apple juice and tolerated it well, denies nausea and states she is feeling better. Is now sitting up with legs dangling off side of table, denies dizziness, nausea and color is returning to normal. BP 104/64, pulse 84. She asked to go home. She was sent home with mother with instructions to observe and call us if she has any questions or concerns.
Numbness in face, similar to that of anesthetic. Numbness lasted for approximately one hour. Numbness was constant for the hour but the intensity level came in waves (it was stronger at some points in time than others, would feel like it was beginning to wear off, and then become more pronounced).
she has injection site pain; she has injection site pain and swelling; little lump in axillary nodes region; she had irritated throat; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional. A 49-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 12Apr2021 as dose 1, single for covid-19 immunization. Medical history included asthma, she suffers asthma from an unknown date to ongoing. The patient's concomitant medications were not reported. On an unspecified date in 2021 the patient experienced she has injection site pain and swelling, little lump in axillary nodes region, she had irritated throat. Patient reported that she has not seen a physician and she was scheduled for a mammography test and she was afraid that the swollen lymph node could affect the results. The patient wanted to know how long the adverse effects will last after first dose administration of Pfizer's COVID-19 vaccine, requested information about whether Advil was an adequate medication for symptoms management caused by first dose administration of Pfizer's COVID-19 vaccine and requested information about whether the second dose of Pfizer's COVID-19 vaccine would be worse as to adverse effects. Treatment received with Advil for injection site pain and swelling, symptoms management. Outcome of the events were unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Headache-Medium, Systemic: Joint Pain-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Systemic: Weakness-Medium, Additional Details: miscarriage
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  ACUTE HYPERCAPNIC RESPIRATORY FAILURE HYPERCAPNIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY
Facial tingling left side cheek area started after leaving clinic. Has subsided some but is still there 28 hours later. I had this tingling 7 years ago and it went away but returned after the vaccination.
after getting vaccinated he got the Covid-19 virus; after getting vaccinated he got the Covid-19 virus; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "after getting vaccinated he got the Covid-19 virus". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt stated that she noticed about a 4 x 3" swelling below the point of immunization that occurred several hours after receiving the shot and lasted about 4 days and went away after ice application and OTC ibuprofen.
Patient fainted and fell on the floor. She hit her head and arm on the wall. We called 911 and had 2 paramedics come to check to see. She didn't need to go to the hospital. Patient looked pale at first, but later felt fine.
Case number PHEH2011US009064 is an initial spontaneous report received from a nurse on 04 Nov 2011 with the follow-up received on 22 Nov 2011: This report refers to an 11-year-old male patient. Her concomitant medication included ADACEL and GARDASIL. He was given only the MenA powder component of MENVEO (batch number: 024011) reconstituted with another liquid (not sure of liquid) intramuscularly on 14 Sep 2011. No adverse event was reported following this medication error. Follow-up received from nurse on 22 Nov 2011: Patient demographics, concomitant medications and date of vaccination were updated.
THE PATIENT REPORTED THAT HE HAD LIMITED RANGE OF MOTION IN HIS LEFT ARM AND THAT HE FELT A PALPABLE KNOT OR GROWTH STARTING IN HIS LEFT UNDERARM AND GOING DOWN HIS ARM TO HIS BICEP.  HE FELT LIKE IT WAS SOMETHING DUE TO HIS LYMPATIC SYSTEM.  HIS ARM WAS STILL SORE AS WELL AND HASNT SEEN ANY PHYSCIAN FOR THIS YET BUT WILL.
Vaccine given 1-31-11; developed swelling in (L) arm and shoulder, Temp 100.3; 2-1-11 - arm warm to touch, swelling to (L) deltoid /(L) supraclavicular area.