chrisvoncsefalvay/vaers-outcomes huggingface dataset:
first shot in 2019, do they need to start over ?; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix vaccine (1st dose received on an unknown date in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter inquired do they need to start over or just get the 2nd shot.
I experienced a stuffy nose until my breathing was obstructed which continued for several weeks after receiving the vaccine. The stuffiness was very similar from when I actually had COVID. My symptoms continued to happen periodically.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided.  On or about 25-OCT-2014, the patient was inoculated with ZOSTAVAX at a hospital as recommended for routine health maintenance and 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 23-DEC-2015, the patient was treated at the same hospital for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or 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, and pain and suffering, and other damages. The outcomes of the events were unknown at the time of reporting. Causality assessment was related. Additional information has been requested.
On 3-8-23 pt. mom called to report pt. was sent home from school due to pain, redness, swelling, and injection site hot to touch Due to lack of appt. availability advised to be seen at urgent care/ER ASAP. Pt. mom reports pain, redness, swelling at injection site started on 3-7-23, the day after Fluzone was given.  Pt. was seen in urgent care center on 3-8-23, was diagnosed with an allergic reaction to vaccine. No medications were prescribed during ER visit. Pt. seen for ER follow-up on 3-9-23, Pt. mom denies any fever, chills, fatigue, lethargy in pt. Clarified pt. injection site was warm to the touch & red. Provider explained to pt. mom pt. had a normal response to injection site caused by trauma to muscle as it's an IM injection. No allergy to Fluzone. Advised to apple warm compress to area & use Children's Tylenol for pain.
Swelling, pain, redness upper arm. Fever 100.5 (reporting office received similar complaints following DTaP)
died as a result of the COVID-19 vaccine shot; This is a spontaneous report from a contactable a consumer reporting same event under the same suspect product for twenty patients.   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The reporter personally knows of 20 people who have died as a result of the COVID-19 vaccine shot. The patient died on an unspecified date. It was not reported if an autopsy was performed.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : PFIZER INC-202101393431 same reporter, product/event; different patient; Reported Cause(s) of Death: died as a result of the COVID-19 vaccine shot
Hives and rash, first appeared on hands and elbows. the next day it spread to buttocks, thighs and feet
An itchy, hot rash is spreading across my back and torso, particularly where my clothes meet my skin, it seems. The skin is red and slightly bumpy. This also happened when I received my first Pfizer dose back in April. According to my card, that dose was from Lot #ER8729. At that time, a very itchy and hot rash spread across most of my entire body. It disappeared within about 24 hours.
L shoulder pain and decreased ROM which peaked at 48 hrs post-injection and persists at a mild level on Nov 30.  Pharmacist  injected vaccines in close proximity to each other and and a relatively high level on the arm.  Findings c/w SIRVA.
This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a subject of unspecified age and gender who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  On an unspecified date the subject received an unspecified dose of Engerix B (unknown).  At an unspecified time after vaccination with Engerix B, the subject experienced not responding to therapy.  A registered nurse reported that she has a subject who was prescribed Engerix B to be given at a "non-responder dosage".  At the time of reporting the outcome of the event was unspecified.  Follow-up received on 09 July 2007 via the nurse indicated that the subject received the first dose of Engerix B on 18 October 2004, the second dose on 22 November 2004 and the third dose on 06 May 2005.  At an unspecified time after the completion of the series, it was noted that the subject did not respond to therapy.  The subject was given a fourth dose of Engerix B on 08 May 2007.
3/6 I woke up with a nerve pain the size of a silver dollar at top center of right thigh where it joins my torso and i still have that pain, 3/9 under distress because of the pain I had a venous ultrasound on both legs with Dr., then I noticed on 3/13 rose pink flesh on both lower calves, 3/18 Dr  sent me for an MRI Imaging of my lower back because of the pain. 3/19 I saw Neuro Dr for Botox on left side of face, I was told that they thought a nerve crossed a vein that caused a tremor on the left side of my face. 3/23 Dr.  had an audio apt. 3/29 I had a full breakout of cellulitis on my lower left leg and it was a deep deep purple red and it itches. 3/30 I was sent to Dr assistant to see if I had extensive back and hip trouble and I was examined physically with movement, they offered a shot at nerve point and water therapy. I put arnicare on the spot and it makes the pain manageable. 4/7 cellulitis, 4/9  I tried to be seen, 4/10 my heart beat irregular, then the rash appear and there was acute pain at the top of my head. ValACYcalovir 500 tab (valtrex) 4/19 Sonogram for arteries in my legs and I was given the doxycycline and prednisone, and today I still have a bright red and swollen ankle on the right and I still have some dried up shingles on my chin and head.  I have photos that I took of my reaction to the vaccine.
High fever of 102.5 on the day after shot, muscle aches, chills. Second day after shot, high fever of 101.2, muscle aches , chills. Third day normal temperature, felt better.
pt recv vax & 25min p/inj devel chills & looked pale;arrived in ER BP was elevated to 130/90 w/no tachycardia & no fever;all systems were neg on PE;no tx was given;pt dx as having an adverse rxn to engerix-B;
Started with extreme fatigue first day of shot. The next day left arm was very hot and swollen. That night a red spot developed down farther on upper left arm than the injection site. Monday morning  many more spots appears at middle of upper arm that were raised and very hot to the touch and eyes and face felt as if it was swollen. Put cold wet wash rag on face and left arm where the spots developed. Call Dr and got in that day at 1:15. He said that it was the lymphatic system that it could have leaked into or got into. He said if it got worse or if I have chest pain to call immediately, and he would get me in that day. My BP was 141/92 which is higher than normal.
At first patient was fine just sore arm.  Approx 2pm the next day we were at Aunt's house & he became very sleepy and fell asleep outside.  I nudged him to see if he was okay and he couldn't lift his head up all he said was "I hate you" (he didn't want the shot and I had a feel well)  I kept nudging him to go inside and he didn't react.  Finally after 25 min I had my brother in law carry him upstairs.  He didn't wake up for it (the kid is 13 that never happens).  Every hour I checked on him and he wouldn't wake up.  I am a nurse do figured the shot made him tired but I did start to get anxious I even sternal rubbed him and he reacted to pain but would not wake up.  Finally around 445 I told my husband we need to make him drink something and I stood him up he would not wake up.  I was trying everything but we got him up enough to gulp down some gatorade.  We put on his sneakers and he basically sleptwalked down the stairs went right to car and fell asleep again.  It was like he was too tired to stay awake.  We got him home and around 515 kept him sitting up in kitchen.  Took him about 20 min to fully open eyes and wake up.    When he was fully awake he said it was like the shot moved from his arm to his whole body when it happened and that was it.  He was sore and achy after that and even today to generalized body.  But he was fine as far as not lethargic after.
2-8-08 Pt called health dept and stated she has been diagnosed with shingles.  Pt placed on Tylenol with codeine and acyclovir 800 mg one 5x day x7 days.
Severe shoulder pain about a week after my injection.  At first I didn't know it was related to the vaccine, but after it passed within 72 hours I realized it must have been a reaction.  I have had difficulty with my right shoulder at various times, and had received the previous (1st) dose in my left arm.  I also received my booster in my left arm.  I had switched arms because I had a mild rash on my left arm following the first dose, but that was much more bearable than the pain in my right shoulder!  I met with the nurse practitioner in my doctor's office who did not believe that it was related to the vaccine and referred me to an orthopedist, but when the pain was gone the next day and did not return I did not follow through with that referral, feeling it was unnecessary.  She had also prescribed a course of anti-inflammatories, which I did not take for the same reason and because I had heard that anti-inflammatory medication might interfere with my immune response to the vaccine.
Grandmother in to report seizure and foaming at mouth, didn't check temperature (no thermometer) but felt real warm.
had shots fot it / still got it once/ suspected vaccination failure; had shots fot it / still got it; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported for reporter's husband. The age at vaccination was not reported. The reporter stated he had Shingles shots and still got the shingle once.  The reporter stated, the physician told him it was not good thing he had shot. He would have had a very sever case of shingles without the Shingles shot. The reporter wonders if the damebis true for COVID? The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
side effects due to Vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects due to Vaccine) in a patient of an unknown age and gender 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 COMPLICATION (side effects due to Vaccine). At the time of the report, VACCINATION COMPLICATION (side effects due to Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
pt had yellow fever vaccine, after arriving home dev itching around site of vaccine, then dev hives on back neck, no constriction of throat, trouble breathing - returned to health center at 1235 and seen by doctor at 1240; received benadryl 50 mg at 1255
Patient received Moderna at approximately 10:38 am. Patient reported his mouth felt like it was on fire at 10:53 am. Patient's face appeared red and flushed. I gave him a Benadryl and water around 10:58 am. A few minutes later patient reported his throat felt like it was closing and his tongue felt swollen. He did not appear to have trouble breathing. I called an ambulance at 11:04 am and they arrived around 10 minutes later. Patient was able to walk to ambulance and they transported him to \Hospital.
Confirmation of unplanned pregnancy once month following administration of Vivotif.  She reportedly dosed the Vivotif during the week of conception.  No adverse effects noted to date.  No pregnancy complications to date.
Information was received on 13-JUL-2017 from a medical assistant who was reporting on behalf of a physician concerning an unspecified patient of unknown age and gender. No medical history or concomitant medications were reported. On an unspecified date, the unspecified patient received a dose of improperly stored VARIVAX (lot N012132, expires 17-APR-2019) reconstituted with properly stored sterile water diluent. No adverse effects were reported. No further details were provided. The vaccine was exposed to temperature 15 degrees F. to 46 degrees F. for 48 hours. There was no previous temperature excursion and it was not as a result of a data logger. Additional information has been requested.
Felt nauseous,. BP low when checked at home this am per pt. Ice applied to neck. Responded well and discharged at 1:35 pm. VS- BP- 130/82, P- 66, Resp- 16 @ 1:25pm.
a dose of PROQUAD was administered with VARIVAX; This spontaneous report was received from a pharmacy technician referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.  On 08-APR-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 1 dose, lot #U024221, expiration date 04-AUG-2023 (strength and route were not provided), with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) 1 dose, lot #U028179, expiration date 08-MAR-2023 (strength and route were not provided) for prophylaxis (overdose). The pharmacy technician reported the information was shared with her by a nurse at one of their facility's clinic. It was unknown if any product confusion occurred, that may have contributed to the error.   This is one of eight reports received from the same reporter.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Apr2022 at 19:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 43 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Seizure disorder" (unspecified if ongoing). Concomitant medication(s) included: NYQUIL; IBUPROFEN; TYLENOL; LAMOTRIGINE. Past drug history included: Metronidazole for known allergies Metronidazole. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: my rapid test turned back to positive; negative, notes: negative rapid test on Day 7. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid (Lot#FY7067) from 26Apr2022 to 30Apr2022.  Clinical Course: Other medication in 2 weeks included Lamotrigine, Nyquil, Ibuprofen, Tylenol. The patient started Paxlovid on Day 1 of symptoms. The patient had a negative rapid test on Day 7. She had no symptoms from Day 4-8. She began to have symptoms again (sneezing, congestion) on Day 9 and my rapid test turned back to positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the Lack of efficacy, Covid-19 Positive and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)
swollen lymph nodes in the groin area; she had bumps all over her body, painful to the touch, in her groin, collar bone, and arm; she had bumps all over her body, painful to the touch, in her groin, collar bone, and arm; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 2 via an unspecified route of administration on 14Aug2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. On 16Aug2021, two days after receiving the dose, the patient experienced swollen lymph nodes in the groin area, she had bumps all over her body, painful to the touch, in her groin, collar bone, and arm. The bumps are on the side of the body where she received the vaccine, the left side. The patient reports feeling the same today, according to the caller. Outcome of the event was unknown. Information about lot/batch number has been requested.
On day after had severe muscle ache; severe headache; nauseous; so cold (could not get warm); had a fever; slept for 15 hours; This is a spontaneous report from a contactable consumer.  A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9265), via an unspecified route of administration on 26Jan2021 17:00 at single dose for covid-19 immunisation.  Medical history included mitral valve prolapse and COVID-19. Concomitant medication included bimatoprost (LUMIGAN), colecalciferol (D3), zinc (ZINC), and ubidecarenone (COQ10).  The patient experienced severe muscle ache, severe headache, nauseous, so cold (could not get warm), had a fever and slept for 15 hours on 26Jan2021 21:00. The patient received no treatment. The outcome of the events was recovered with sequelae on an unspecified date.
2nd day: extreme soreness in entire left arm. difficulty using arm.  4th day: allergy conditions, i.e. watery eyes, sinus drainage, coughing. Continued muscle pain.  9th day: deep muscle pain from left shoulder to elbow; difficulty raising left arm.
p/vax exp 2 1/2oval (red outlined) area which was swollen & was painful w/pressure;MD visit was required;pt condition unk; Case, reference number 1999013570-1, is a spontaneous report from a physician concerning a fourtenn year old female. No allergies, medical history, and concomitant medications. No illness at the time of vaccination. The patient received the first dose of LYMERIX (pre-filled syringe) without incident on April 24, 1999 to prevent Lyme disease. The patient received the second dose of LYMERIX (pre-filled syringe) on 27-May-99. Five days later, on 01-Jun-99, the patient experienced a 4 inch oval (red outlined) area around the injection site which was swollen and was painful with pressure. A doctor visit was required. No treatment was given.
Father stated that the evening after immunization was administered thigh swelled, became hard to touch had bruised appearance, felt sore. ice was applied, Benadryl administered - Soreness lasted only one day. No fever. Affected entire anterior area of thigh.
throat opening appeared restricted, swallowing became difficult, chills, fever 100, achiness throughout body joints; next morning vision was blurred upon awakening (general flu-like sx for approx 48 hrs;)
This spontaneous report was received from a Medical Assistant referring to an unspecified patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not reported. On 26-JUN-2017, the patient was vaccinated with one expired dose of VAQTA 25/0.5, with lot # M009377 and expiration date on 17-JUN-2017 (route of administration was not provided) for prophylaxis. It was reported, that the patient did not experience any adverse events and that no product quality issue was involved. Additional information has been requested.