chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 01-JUL-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # H010515, expiration date: 13-FEB-2014), 25 mcg/0.5 ml 1 standard package vial of 2.5 0.4 ml, intramuscular, the vaccine which had expired on 13-FEB-2014. No adverse effects were reported. Additional information has been requested.
This spontaneous report as received from a 70 year old female consumer reporting on herself with a history of four bowel obstructions. The consumer reported that on 29-JUN-2012, was vaccinated with a dose of ZOSTAVAX in her right arm (dose, route and lot number not reported). No other co-suspects were reported. Concomitant medications included ZOLOFT, simvastatin (manufacturer unknown), omeprazole, LIDODERM, fentanyl, IMITREX (sumatriptan), OS-CAL and minerals (unspecified), CENTRUM. It was reported that in the evening of the day that the consumer was vaccinated on 29-JUN-2012, she experienced an area of redness that was between the elbow and the shoulder underneath the top of the right arm after receiving ZOSTAVAX. The redness was about two and one half by one and one half inches in diameter. No lab diagnostics studies were performed. No treatment was given for the experience. The symptoms started to improve on 01-JUL-2012, the consumer was recovering. The consumer did not seek medical attention. The relatedness for area of redness that was between the elbow and the shoulder underneath the top of the right arm after receiving ZOSTAVAX vaccine, the redness was about two and one half by one half inches in diameter was unknown for ZOSTAVAX. Additional information has been requested.
1 day after booster, same side armpit lymph node swelled so large that arm couldn't be placed down. Ibuprofen helped keep at bay. 3 days after booster, opposite side lymph nodes in neck, back of head, face swelled, tingled, and hurt to touch. Swelling in armpit of booster reduced. 4-5 days after booster, continued swelling and pain in neck, back of head, face, continued ibuprofen. 6 days after booster rash and itching continued now with expansion to chest area. Made immediate Dr appointment and was diagnosed with Shingles at age 43. Started on Antiviral - Valacyclovir 1g tablet. 7 days after booster and one day on antiviral, continued expansion of rash, pain, swelling. Continued bed rest and ibuprofen. 8 days - 10 days continuance of the same.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On 29-JUL-2014 the patient was vaccinated with an expired dose of M-M-R II rHA (dose not reported), batch #J008882, lot#0293AA, expiration date 27-JUL-2014, subcutaneously. No known adverse effects were reported. Additional information has been requested.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of an unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown day in 2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX), as prescribed and/or administered by a healthcare provider in a clinic for the long-term prevention of shingles and zoster-related conditions (dose, route, and lot # not provided). Subsequent to patient's zoster vaccine live (ZOSTAVAX), she was treated by the physician for shingles. As a direct and proximate result of patient's use of the suspect vaccine, the patient had and would 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 would continue to suffer such losses, and damages in the future. The outcome of herpes zoster was reported as not recovered. The event was considered to be related to zoster vaccine live (ZOSTAVAX).
About an hour after he received his vaccine, he experienced tachycardia, tremors that lasted about an hour, his hands and face turned red, he experienced mental fogginess, and his vision "went out" for a short time. He ate a little bit of food, took some food, went home and rested and his symptoms calmed down. The next day (Saturday) he just felt fatigued. He did say that he had not ate breakfast before receiving his vaccine. He also spoke with a family member who is a doctor but did not actually go to a doctor's office/clinic.
This is a spontaneous report from a contactable pharmacist via Pfizer Medical Information. This 71-year-old female patient received on 06Feb2015 PREVNAR 13 (lot number J77185, expiration date Apr2016, NDC 0005197105) at 0.5 ml single dose intramuscular. Relevant medical history was none. Concomitant medications were none. The pharmacist did not adequately shake PREVNAR 13 before administering it and patient said that it was painful when it was injected but then she felt fine later. Causality was not provided. Outcome was unknown.
This spontaneous report as received from an other health professional refers to a patient of an unknown age. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 lot # M013156 for prophylaxis. On an unknown date, the patient experienced incorrect product storage. No adverse effects were reported. Temperature excursions ranged from 47 degrees Fahrenheit to 77 degrees Fahrenheit within time frame of 4 hours. Previous temperature excursions ranged from 47 degrees Fahrenheit to 77 degrees Fahrenheit within time frame of 1 hour. Data logger was involved. Sender's Comments: US-009507513-1708USA010559: US-009507513-1708USA010541.
per pt. had severe headache and feeling of "skin burning sensation" and he sensed  feeling of muscle rigidity . was told go to er he called them and they told him that could take some time for reaction to subside and they were 6 hour wait so he chose not to go in took allergy medication . we called pt. 2/9 and pt. said still didnt feel right but was better
After 48 hours I had stomach issues, I started to get feverish and I went to the doctor. It was diarrhea with severe stomach cramping. I had muscle aches. They just told me to monitor the symptoms and just take enough fluids. It resolved around 18 hours.
Large swelling at injection site,( ice applied)  ongoing headache (tylenol )  inability to use arm due to weakness and pain, chills and slight fever,  jaw pain
PAIN Narrative:  C/O some pain when in shower. states "I noticed my left arm is still kind of swollen but now I just notice it when my left arm is down and it kind of  feels like its swollen, like its a gumball. its tender under the arm but not at the  injection site"
I received my first Moderna vaccine on 1/18/21. Around day 8 a large circular rash appeared on the arm where I received the injection that was very itchy and swollen. I am part of V-safe, but thought it was a bug or spider bite at the time, so I didn?t report it. When I realized it is more likely due to the vaccine, the V-safe app stopped requesting check-ins, so I am reporting it here. The rash started on Tuesday, 1/26 in the evening and is still there as of today, 1/31.  It is a large red, swollen circle. I am happy to provide additional information if needed.
Vaccine injection was given on 10/01/08. area of left deltoid-red, warm, tender site approximately 5x4.5cm noted at approximately 3:00pm 10/02/08.  Recommended ice to area 5-10 minutes four times a day. Return to clinic if area worsens.
Very achey, fever,  no appetite. Took ibuprofen and dayquil  started to feel better by 7:00pm
Red Rash on neck and torso 1-4 days after 2nd shot; other vaccine same date; This is a spontaneous report from a contactable consumer (patient). A 39-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 30May2021 08:00 AM (Batch/Lot Number: EW0167) as 2ND DOSE, SINGLE (ALSO REPORTED AS FIRST DOSE, PENDING CLARIFICATION) for covid-19 immunisation at Hospital. The patient received other Pfizer vaccine on the same date 30May2021 (Lot number: EW0175) as first dose in right arm. Medical history included colitis ulcerative and known allergies to penicillin. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. No Covid prior vaccination. No Covid tested post vaccination. The patient experienced red rash on neck and torso 1-4 days after 2nd shot (as reported) on 31May2021 with outcome of recovering, the treatment for this event included antihistamines.
Patient in to clinic 11/13/2018 for two scheduled vaccines. 0840; Vaccine #1 given in left arm, 08: 42 vaccine #2 given in right arm. Patient immediately became diaphoretic and shaky, closed her eyes and did not respond to questions for about 5 seconds before opening her eyes and talking. PHN directed third nurse to notify emergency services. At this time Public Health Nurse and PHN were able to move patient to lying position. Cool compresses applied and vital signs: B/P 93/65 Pulse - 76. Patient remained in lying position for 5 minutes and then moved to sitting position. Continued cool compresses and at this time offered juice and water. Patient states she did eat breakfast this am and consumed the juice. EMS arrived and report given to staff. Patient states she feels better at this point but EMS encouraged her to sit in the ambulance in parking lot. Mom agreed to this. Patient transported to ambulance via stretcher, rested and then went home in moms vehicle. 11;28 PHN called mother to follow up with her re: status of patient. Voicemail left at this time. 11/14/18 - Follow up phone call made. 12:01: Mom called back and stated after the vaccine yesterday she did not follow up with Primary care physician. She states that patient has had headaches on and off but was able to go to school this am. PHN did encourage mom to follow up with PMD, RN.
Developing more frequent intermittent tingling to right side of scalp and right ear roughly following the pathway of the auriculotemporal nerve on the right side of the head.
This case was reported by a consumer via call center representative and described the occurrence of stiff neck in a 66-year-old male patient who received Influenza vaccine. Co-suspect products included Pneumococcal vaccine and ANORO ELLIPTA unknown (batch number 6ZP6390, expiry date 30th April 2018) for chronic obstructive pulmonary disease. The patient's past medical history included bladder catheterization. Concomitant products included albuterol and SYMBICORT. On 6th October 2016, the patient received Influenza vaccine, Pneumococcal vaccine and ANORO ELLIPTA 1 puff(s) twice daily (2 puff(s) daily). On 6th October 2016, less than a day after receiving Influenza vaccine and Pneumococcal vaccine, less than a day after receiving Influenza vaccine and Pneumococcal vaccine and 1 hr after starting Influenza vaccine and ANORO ELLIPTA, the patient experienced stiff neck and high pulse rate. ANORO ELLIPTA was continued with no change. On 6th October 2016, the outcome of the stiff neck was recovered/resolved. In October 2016, the outcome of the high pulse rate was recovered/resolved. It was unknown if the reporter considered the stiff neck and high pulse rate to be related to Influenza vaccine, Pneumococcal vaccine and ANORO ELLIPTA. Additional details were provided as follows: The patient reported that approximately 1 hour after taking an ANORO dose in the doctor's office, he developed a stiff neck that resolved later in the day. He also experienced a high pulse rate about 8 hours after his 1st dose. His pulse usually runs about 84 and it went to 104. Then it came back to normal. The patient also received an unknown manufacturer's influenza vaccine and pneumonia injection on the same office visit. The patient had denied permission to contact their physician.
7/1/05 at 11:16 AM, pt administered Twinrix vaccine. While getting vaccine, pt fainted. Code blue called. Vital signs taken, 11:17, pt out approx. 30 sec. Lay down on sofa 11:40, vital signs taken again, pt conscous.
pt says he had diarrhea later in the night after getting the vax. He had left arm pain last about an hour.  He went to bed but continued having diarrhea several time throughout the night.  He was not able to get out of bed with out help since his legs were like noodles. He used a portable commode to use the bathroom.  He says it is really weird, like he has trouble going to the bathroom but when he does, it is diarrhea.  On 4/9/2021 he still has these symptoms and he is waiting for a CB from his PCP.
Patient received Moderna COVID vaccine on 5/5/2021. It was later discovered that she received a dose of Pfizer vaccine at another facility on 1/6/2021. Patient was monitored and no adverse reactions were noted.
HAND SWELLING, FEET WERE SWELLING; LEG CRAMPS, RIGHT LEG CRAMPING DURING INTERACTION; THROBBING PAIN IN LEFT SHOULDER; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: high cholesterol, rheumatoid arthritis, non-alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced hand swelling, feet were swelling, leg cramps, right leg cramping during interaction, and throbbing pain in left shoulder. Laboratory data (dates unspecified) included: Ultrasound scan (NR: not provided) No blood clots. Treatment medications (dates unspecified) included: prednisone, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from leg cramps, right leg cramping during interaction, and the outcome of hand swelling, feet were swelling and throbbing pain in left shoulder was not reported. This report was non-serious. This case, from the same reporter is linked to 20210815521.
NauseaVomiting Chest pain heaviness, fatique Narrative:  Other Relevant History:
The patient developed welts/hives 24 hours after receiving immunizations. They started on the left upper arm at the site of vaccines. The injection site of the anterior part of the arm welted. The injection site towards the posterior side of the arm was just a little red. It then progressed to any part of her skin that would be touched, it would then welt up once touched all over her body. These symptoms continued for 7 days. The patient's mother spoke with the on call doctor at the onset of her symptoms and was advised to give BENADRYL. The patient's mother did not seek any additional medical care or advice. The symptoms resolved after 7 days. The patient's mother just informed us of this reaction today, 6/4/18.
Initial and follow-up information has been received from a 66 year old retired registered nurse with no known drug allergies or pertinent medical history who on 29-FEB-2008 (previously reported as 28-FEB-2008) was vaccinated SC in the left arm with a first dose of zoster vaccine live (Oka/Merck) at 11:30 (lot# 658325/1429U). There was no illness at the time of vaccination. Concomitant therapy included simvastatin (manufacturer unknown) , quinapril HCl, unspecified thyroid medicine, and verapamil. Subsequently, on 09-MAR-2008 she developed "sensitive skin" below the injection site to about 2-3 inches above the elbow. She stated she did not experience any pain, redness, fever, swelling or rash to the area. She stated she only had discomfort if the area was touched, even fabric irritated the area. The patient stated this lasted approximately ten days. She also mentioned that later some sensitivity of skin to her left flank area was developed. This sensitivity was not as severe as the sensitivity on her arm. Medical attention was not sought. At the time of the report the patient recovered on approximately 19-MAR-2008. There was no product quality complaint involved. No additional information is expected.
Immediately felt pain at site of injection. Felt a pop in shoulder, felt injection had not been given properly. Got worse as day went on by evening around 6:00pm could not raise arm. Kept her awake all night unable to move without pain. Took Tylenol. Hand and arm felt swollen. By the30th able to move arm a little, by Nov 1st able to raise arm, but continues to be sore. Still painful if roll on it at night.
This spontaneous report as received from a licensed practical nurse refers to a licensed practical nurse and refers to 20 years old (previously reported as 16 years old)non pregnant female patient with gravidity 0, parity 0, and drug reactions/allergy to aspirin, MOTRIN. On an unknown date the patient was vaccinated with the dose of GARDASIL (dose, frequency, route of administration and lot number were not reported). On an unknown date the patient experienced drug reaction or allergy on GARDASIL injection. The outcome of the patient event was unknown. The relatedness between the event and GARDASIL was not reported. This case is linked with 1310USA0014123, considered the same patient. Additional information has been requested.
Sore at vaccine site.  I started having fever, chills, body ache, and headache.  Had very serve headache around and behind my both eyes.  My left eye the blood vassal burst. The headache went on for a week.  Talked to a doctor over phone.  Diagnosis with migraine and gave presentations for ibuprofen and magnesium.
Pt. states that after receiving the 3rd Booster of Phizer 09/27/2021, started experiencing symptoms 09/28/2021 of body aches, chills, 14hrs, gum swelling *Herpes simplex in the mouth. Symptoms have subsided.
Child broke out in slight rash on Friday, 2-29-08 and rash kept spreading over body.  Mother called doctor's office today, 3-4-08 and spoke with the doctor stating child has hives all over body.  Benadryl to help symptoms.
Information was received on 26-MAY-2017 regarding a case in litigation concerning a patient (age and gender not reported). Medical history, concurrent conditions and concomitant medications were not reported. On or about 16-SEP-2013 the patient received a dose of ZOSTAVAX (lot # and dose not specified) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 31-MAR-2016 the patient was treated for a vesicular outbreak that was diagnosed as herpes zoster (shingles). As a direct and proximate result of these malfunctions, 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.
Pt came in with vaccination card. Patient had been previously vaccinated with Pfizer and was requesting a booster of Moderna. Patient's birthdate was misread and patient was given a booster dose of Moderna even though patient is 17 years old. Patient did not have an immediate adverse reaction and left without any adverse signs or symptoms.
Erythema, pain, swelling at injection site (Right deltoid). Patient also experienced diarrhea.
Fever and hives. Given Benadryl for hives for 2 days, stopped the Benadryl and the hives came back.
1/23/10 12:20pm client said felt dizzy 3 minutes after receiving H1N1 nasal mist but went home and returned to clinic in 2hrs with dizziness, pale, anterior chest tightness, feeling of disorientation. BP 110/80, P80, Ox3, lungs clear, given BENADRYL .25cc, 25 mg IM with reduction in symptoms, no swelling or rash seen. 12:45pm - recovered and sent hom with instructions to go to ER if returns, no egg vaccines. 1/25/10 called client - fully recovered but felt dizzy x 24 hours.
Clinic Location: Facility   Situation: Possible reaction to flu vaccine               Name of Reactive drug/vaccine:  Flulaval             Time of Immunization Administration: 1207   Time of Reaction: symptoms reported to me by patient via telephone at approximately 1245   Subjective symptoms reported by patient: After vaccination, patient's coworker came to flu clinic and reported patient not feeling well. Coworker called patient on phone and I spoke to patient. Patient reported feeling sweaty, lightheaded, nauseous, and lower abdominal pain. Rated pain a 10/10 and was worsening. Patient told to call emergency services.   Anaphylaxis: No               Immediate nursing interventions:  Advised patient to call EMS for transport to ED   Was the Emergency Protocol for Anaphylaxis Initiated?  No   Patient response to interventions and additional details: Patient stated she would call emergency services
This spontaneous report was received from a physician and refers to an unspecified number of patients of unknown age and gender. Medical history and concomitant medications were unknown. On 21-JAN-2016, an unspecified number of patients were vaccinated with improperly stored doses of ZOSTAVAX Lot # L032184, expiration date 25-NOV-2016 (route, dose and anatomical location were not reported). No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Could not get out of bed; Felt weak; Lymph nodes in the Groin area and Right Armpit hurts; Fever; Severe Chills; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (Could not get out of bed), ASTHENIA (Felt weak), LYMPHADENOPATHY (Lymph nodes in the Groin area and Right Armpit hurts), PYREXIA (Fever) and CHILLS (Severe Chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced ASTHENIA (Felt weak), LYMPHADENOPATHY (Lymph nodes in the Groin area and Right Armpit hurts), PYREXIA (Fever), CHILLS (Severe Chills), NAUSEA (Nausea) and HEADACHE (Headache). On an unknown date, the patient experienced BEDRIDDEN (Could not get out of bed). At the time of the report, BEDRIDDEN (Could not get out of bed), ASTHENIA (Felt weak), LYMPHADENOPATHY (Lymph nodes in the Groin area and Right Armpit hurts), PYREXIA (Fever), CHILLS (Severe Chills), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants or treatment medications were reported.