chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I am a registered nurse. I have been getting the flu shot yearly and never had this happen. Since the day I received the flu shot my hips and legs are hurting terribly everyday. I have to work 12.5 hour shifts and I?m crying in pain through every shift. I know it?s the shot because around 8pm that evening my left hip started aching. Then the ache moved down my leg, then I started aching a couple days later in my right hip. Now the pain is in bilateral hips and legs. I am having trouble working. I?ve done so many things to help this pain but there is nothing. I can?t believe that I take care of patients everyday as a healthy strong nurse only to become a patient with severe pain after a shot. I can?t ever take this shot again. I am so disheartened. I need someone to help me.
This spontaneous report was received from a pharmacist via a consumers and refers to a 82-year-old female patient with arthritis, diabetes mellitus, asthma, hypertension, blood cholesterol increased and persistent headaches. On 30-JUL-2016, the patient was vaccinated with a dose of ZOSTAVAX one vial, once, subcutaneously in the left arm (lot# M014310; expiration date: 26-MAY-2017). Concomitant therapies included gabapentin, LIPITOR, metformin, omeprazole (manufacturer unknown), SINGULAIR, prednisone (manufacturer unknown), amlodipine, FIORICET. The patient called to the pharmacist, in approximately 2016 (reported as ten days after vaccination). She informed that she experienced pain and warmth at injection site on the left arm and numbness radiating down the arm, in approximately 2016. On 22-AUG-2016, the patient's daughter called to the pharmacist and reported that the patient's pain and numbness had not resolved and patient was not able to use the arm. The patient received a treatment (unspecified), for the events. The outcome of warmth at injection site on the left arm and not able to use the arm was not reported. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
COVID INFECTION, RHINORRHEA Narrative:  COVID infection after completing COVID vaccine series 01/16 COVID vaccine dose #1 02/06 COVID vaccine dose #2 04/24 tested positive for COVID 04/25 reports headache, rhinorrhea started 4/19, states was exposed to family member with known or suspected COVID 04/26 mild HA, rhinorrhea 04/27 no symptoms
Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported CHILLS (non-serious), outcome unknown. The patient got chills after both of her shots.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Linked Report(s): US-PFIZER INC-2021252736 Same reporter and drug, similar event, and different patient.
Developed high fever 8/1/12. Developed maculopapular, erythematous rash trunk, arms, legs on 8/2/12. Generalized. (-) oral lesions. Possible acute vaccine induced Varicella.
patient received the extra dose of menactra with no adverse event; Initial information received on 24-May-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 16 years old male patient who received the extra dose of menactra with no adverse event while receiving vaccine meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 23-Jul-2021, the patient received suspect at a dose of 0.5 ml total meningococcal A-C-Y-W135 (D CONJ) vaccine (lot U6920AA, expiry date: 15-Apr-2022, form, strength: not reported) via intramuscular route in the left arm for immunisation.  On 23-Jul-2021 the patient received the extra dose of menactra with no adverse event (extra dose administered, latency: same day) following the administration of meningococcal A-C-Y-W135 (D CONJ) vaccine.   It was reported that when the patient returned for a wellness check this year, it was discovered that they had received the extra dose of menactra.  Action taken: not applicable.   Outcome: Unknown.    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 guidelines. 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.; Sender's Comments:  01116730:
Developed migraine and loss of taste 12/30/20 (currently being tested for COVID-19). Developed right (side of injection) axillary pain 1/2/21 which lasted several days. Hives developed on 1/7/21 - ordered Benadryl without relief. Went to ER 1/9/2021 for worsening hives - Pepcid and prednisone ordered.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: FP7137), in right deltoid for covid-19 immunisation; influenza vaccine (FLU), as dose number unknown, single (Batch/Lot number: unknown), in right deltoid. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, unknown manufacturer.), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "he arm is so painful and it is very uncomfortable". Additional information: The received Booster (reported as yesterday) and also Flu shot (unspecified Flu shot) in my right deltoid and the have been up all night, the arm was so painful and it was very uncomfortable. Additional Context: Concern, consumer stated, "This was not an emergency by any means but the patient received the Booster yesterday evening about 6 O'clock in (State withheld) at (name withheld) and the patient was also given the Flu shot (unspecified Flu shot). They were given in my right deltoid and the patient have been up all night. The patient was just, the arm was so painful, the just want to know if the patient can take some sort of (treatment) to relieve some of that.". Consumer stated, "It is just very uncomfortable. I just wanted to know if I could take like a Motrin or something to get some relief from that." In response consumer stated, "Well that won't help me." Response was provided, consumer was informed to visit to nearest Emergency room in case of emergency. In response consumer stated, "Well they are not going to because it is Sunday and nobody is going to tell me until tomorrow morning. Thank you anyway." In response consumer stated, "Well they are not going to because it is Sunday and nobody is going to tell me until tomorrow morning. Thank you anyway." No follow-up attempts are possible. No further information is expected. Sender's Comments:
BEST NIGHT SLEEP IN A LONG TIME,  FEELING GREAT; This spontaneous report received from a patient concerned a 75 year old white female. The patient's height, and weight were not reported. Patient reported that she normally did not sleep well (at the time of vaccination). The patient initially received covid-19 vaccine ad26.cov2.s (Dose number in series 01) (suspension for injection, route of administration not reported, batch number: 041AQ1A, and expiry: unknown) dose was not reported, 01 total was administered on 05-APR-2021 to the left arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, after the primary dose of the Janssen COVID-19 vaccine, she had the best night sleep in a long time, and was feeling great and that normally doesn't sleep well (Unexpected therapeutic benefit) (Dose number in series 01). The patient received additional covid-19 vaccine ad26. cov2. s (Dose number in series 02) (suspension for injection, route of administration, batch number and expiry were not reported) dose was not reported, 01 total administered on 19-NOV-2021 for prophylactic vaccination. No adverse events/issues were observed with the Janssen booster (Dose number in series 02). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of best night sleep in a long time, feeling great was not reported. This report was non-serious.
On 3 December 2021, I received the Moderna booster shot. On 4 December and 5 December, I experienced chills, fatigue, and hot flashes.   On 13 December 2021, I began experiencing hives.  The hives started on my neck and then spread all over my body.    On 15 December 2021, I went to my PCP and received a steroid shot, Famotidine (40 mg, that I was instructed to take for 14 days), and Cetrizine.    This did not completely resolve my symptoms and I continued to take Benadryl (25mg) every 6-8 hours.   On 18 December 2021, as the symptoms still were not improving, I called Dr. and received prescriptions for Hydroxyzine (25mg)  to be taken as needed and to replace Benadryl, and Prednisone (60 mg for 2 days, 40 mg for 2 days, and 20 mg for 2 days).   As of 29 December 2021, I completed all assigned meds (Famotidine and Prednisone).  Since this date, I have continued to experience hives all over my body.    Taking an antihistamine will reduce the symptoms, but as soon as the medicine wears off the hives are back.
Patient came to pharmacy and reported a very painful shoulder which she could not move.  Patient could not move her arm hardly at all. Advised patient to seek medical care to  have shoulder examined.
Received 2nd dose of Moderna COVID vaccine on 6/9/21.  On 6/10/21, he approached the nursing station and reported: " my left foot feels numb, i tried to scratch it, i don't feel it." " It started since the last time i had my first Covid vaccine." Nurse practitioner examined patient 6/10/21 and wrote the following: "Nursing staff reports that patient complains of parethesis to left foot. States that "the side of  his left foot feels numb and tingles at times. Some times it is painful"  O:  left foot has no swelling or discoloration. Temperature is appropriate. His shoes look snug but he denies that his shoes feel too tight  A:  Peripheral Neuropathy vs ill fitting shoes vs Decrease peripheral circulation r/t OSA  P:  Gabapentin 100 mg tid prn       Instructed patient to remove shoes and socks when he was not up and walking and let feet breath       Instructed patient to place feet on pillow to slightly elevate them when he is in bed to increase circulation       Continue to monitor for any other rcomplicaiton"   First dose of vaccine was given 5/12/21 but there is no documentation of patient making this compliant following that dose.
Jan 2021 -First vaccine after still having antibodies after giving convalescent plasma 7 weeks of Covid headaches.  Tried HBOT to treat headaches. Chronic fatigue after Covid 19 in March 2020  August 27, 2021 2nd vaccine Pfizer Oct 6, 2021, 3rd vaccine Pzizer Oct 30 began severe head pressure, as though temples are being squeezed and brain is too large for skull. Full body rash after all 3 vaccines. Just received a referral to Long Covid Clinic.
Dizziness Euphoria feeling Diarrhea Cold sweats Sore throat Injection site pain
This spontaneous report was received from a registered nurse and refers to a 2 year old male patient. The patient's concurrent conditions and medical history were not reported. On 07-DEC-2016, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(manufacturer unknown) lot # M018436 with expiration date of 13-APR-2018 (dose, route and frequency were not reported) reconstituted with properly stored sterile diluent (DILUENT MRK) for prophylaxis. No adverse effects were reported. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 71 days. It was reported that there was no need to repeat vaccine. No previous temperature excursion. The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved in this case. No further information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1705USA014053:
Large (4 in. diameter), raised, erythematous area below injection site. Painful to the touch. Border irregular and not well demarcated. Resolved after 2 days.
Following the Pfizer vaccination, patient experienced a vasovagal reaction with syncope lasting approximately 4 seconds. Patient appeared to be anxious prior to receiving the vaccine and exhibited stress related symptoms prior to becoming flush and "slumping." Medical personnel on staff attended to her monitoring blood pressure and pulse. Patient was laid down with legs elevated to help return blood flow. Patient was then monitored for 30 minutes and given some food and water. Upon leaving the facility, patient appeared to have regained normal function.
p/vax pt exp projectile vomiting, irritability, refusal of feedings, bloody stools; dx intussusception
I started to feel a little off and I thought I had a Sinus Infection coming on. About four days later I felt horrible when I woke up. I went to get tested in the park. I had a terrible Migraine Headache. My face and neck hurt all over. No painkillers would work. It was the worst headache of my life for four days. I had fever, chills, body aches and fatigue. I did have a cough like a tickle which made me cough constantly. It is still there sometimes after five weeks. I did notice some improvement with my flu-like symptoms after seven days. I stayed quarantined for ten days. I tested positive on a home test after eight days. I felt exhausted in the afternoons for about two weeks after the initial symptoms.
Breakthrough case admission after two vaccines Pfizer 6/28/21 Lot3 Ew0196;  Pfizer 9/2/21 Lot# FC3183
fever 101.8 f for 1 day., mind fog, ache and pain,for 2 days form a flu shot. fluad quadri 0.5 ml inj seqi
Shortly after receiving Defendants' Zostavax vaccine, Plaintiff suffered a sudden onset of red bumps and rash that spread on his body. Plaintiff was diagnosed with a rash like shingles.; This initial spontaneous report was received from a lawyer regarding a case in litigation involving a male patient (pt) of unknown age. No information about the pt's pertinent medical history, concomitant medications and drug reactions or allergies was provided.     In or around July 11 2017, the pt was inoculated with a dose of zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, route, frequency, lot/batch # and expiration date were not reported).     Shortly after receiving zoster vaccine live (ZOSTAVAX) approximately in July 2017, the pt suffered a sudden onset of red bumps and rash that spread on his body, the pt was diagnosed with a rash like shingles (rash vesicular). As a direct and proximate result of zoster vaccine live (ZOSTAVAX), pt symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX) product. The 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), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), 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, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was reported as not resolved. The reporter considered the event to be related to zoster Vaccine Live (ZOSTAVAX). The reporter considered the event to be disabling.
Patient had adverse reaction 10 minutes post vaccination. RN noted large reddened area to bilateral thighs where immunizations were given. Dr was called and came to immunization clinic; examined pt, and ordered EpiPen Jr for pt. Pt given EpiPen Jr 0.15mg injection. Pt never showed any signs/symptoms of distress.
Parents reported nausea/vomiting in parking lot, vomited phlegm/undigested rice - patient breathing unlabored, color even + good, no angioedema or other edema, no SOB. Parents reported hx of occasional N/V associated with emotional upset at times, restless behavior normal for autistic diagnosis Vitals: BP N/A, 88, 16 Patient discharged stable to home with parents, instructed to call 911 if any SOB, difficulty breathing, or other concerns
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication were reported. No treatment medication were reported.   This case was linked to MOD-2021-395985 (Patient Link).
Primary Series: Janssen  Booster dose: Pfizer Vaccinated: 16:59 Reaction: 17:15 Pt reports feeling "a little dizzy" 16 minutes after vaccination, reported being nervous before getting booster  Vitals: @1720: 147/84, 58, 20, O2 100% -> @1732: 140/84, 63, 20, O2 99% Pt was taken to clinic via ambulation and laid down for several minutes and reported feeling better. He was also given orange juice, water, and graham crackers. Pt reported feeling back to normal with dizziness resolved and no other adverse side effects reported or observed. Pt also reported he had not eaten or drank anything since 9:30 today and was also nervous about receiving the booster vaccine. Pt was educated to stay well hydrated day of any needlestick injection and for future vaccinations to be given laying down. Pt was able to ambulate independently with steady gait, out of facility at 17:34.
30 mins post-vaccination, patient complained of left hand feeling swollen and distended veins from her reported baseline without loss of range of motion , sensation. Hands were on exam symmetrical in appearance without edema noted. Patient otherwise without complaints of wheezing, dermatological changes, SOB, itching, or pharyngeal swelling.   Temp 100.4 HR 76, RR 20 and regular, BP 110/72 left arm  Symptoms resolved by 4:07 PM at time of departure from site.
A report has been received from a Health Professional concerning a 52 year old, male subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on 10-Sep-2013. Tlt was reported that the patient had inadvertently administered FLUMIST to a patient over 49 which started on 10-Sep-2013. The outcome of the event of inadvertently administered FLUMIST to a patient over 49 is unknown. The report was considered to be non-serious.
Felt sick with second covid vaccine; High Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (High Fever) and MALAISE (Felt sick with second covid vaccine) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced PYREXIA (High Fever). In August 2021, the patient experienced MALAISE (Felt sick with second covid vaccine). At the time of the report, PYREXIA (High Fever) was resolving and MALAISE (Felt sick with second covid vaccine) outcome was unknown.            Concomitant medications were not reported.  Patient reported non-serious events had both covid vaccines and did had high fever and felt sick with second covid vaccine with HUMIRA (ADALIMUMAB).  In 2021, the patient experienced had both covid vaccines and did had high fever.  MODERNA COVID-19 VACCINE (COVID-19 VACCINE MRNA (MRNA 1273)) was also considered suspect.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Causality for HUMIRA(ADALIMUMAB) The reporter's causality for the event(s) of had both covid vaccines and did had high fever with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of felt sick with second covid vaccine was not provided.  Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-624937 (Patient Link).
9 minutes after receiving Janseen vaccine pt reported feeling lightheaded. He was asked to lay down on exam table for 10 minutes and this feeling resolved.
Call rec'd at 9:30am 11/22/02. pain from rt side of neck to wrist (incl. upper knot at wrist, rt side. No redness. Had pneumonia that in rt arm delt. In 11/21/02 "allergic reaction, lymph glands in chest and under arm Rx Benadryl q 4 hrs. To return if no improvment by tom. 11/23/02."
I was 7 weeks pregnant at the time of receiving Dose 1 of the Moderna Covid vaccine. I began experiencing vaginal bleeding on Wednesday April 28. The bleeding continued and began heavier so I went to Urgent Care on Friday April 30. May 1 I experienced a miscarriage and lost the pregnancy.
Chest pain and left arm pain 8 days after shot. Pain turned to tingling then numbness then pain again creeping up arm into neck and side of left face. Injection area became itchy, sore and swollen. Light headed, nausea, hot & cold sweats began. Rapid heart rate through the night went to ER the next day. ER Dr. confirmed I suffered mild heart attach after 2nd series of blood work & tests came back at which point I was admitted and transferred to hospital to be monitored overnight & have tests ran the next morning, as the ER I was at was not equipped to handle cardiac patients.
pt recv vax 13JUL98 & 13JUL98 pt exp flu-like sx, muscle soreness & spontaneous nose bleeds;pt recovered from flu-like sx, muscle soreness & spontaneous nosebleeds;
This spontaneous report as received from a pharmacist refers to a female patient of unknown age (no demographics were provided for the patient). On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route and lot # not reported). The pharmacist had a patient, who received ZOSTAVAX and then got a headache. The patient talked to the pharmacist for medical attention. No treatment was given for headache. No lab diagnostics studies were performed. The outcome of headache is unknown. Additional information has been requested.