chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lower back pain started on May11th and I proceeded to stretch, receive massage and use my foam roller.  It lightened up in intensity and then after a day or two without pain, my entire hip girdle seized up.  QL, and Psoas bilaterally were so tight and painful that I couldn't walk for the 3 days over Memorial Day weekend.  I have been on muscle relaxers since June 1st. I tried to reduce pills last Saturday and by Sunday, I couldn't walk again.  I have been unable to work fro June 1-4, 2021. I am a massage therapist and cannot work in pain or unable to stand.
Vax given 19FEB91 - developed temp 104.9 21FEB91; Tx Advil, Temp down 99 in ER; Doing well on Follow up
This is a spontaneous report from a contactable pharmacist. This is third of the three reports from the same pharmacist. A 37-years-old female patient received PREVNAR 13, single dose, on unknown date. Concomitant medication included BYSTOLIC, trazodone, levothyroxine, ADVAIR, PROTONIX, propranolol and LEXAPRO. On unknown date the patient experienced a huge terrible bad reaction. She had cellulitis, rash on her arm with a hard knot, hematoma and abscess. The patient had to have surgery. The pharmacist mentioned that this is the third patient who had had a very bad reaction to PREVNAR 13. According to the pharmacist the reported events were due to PREVNAR 13.
Vaccine administered after after 4 temperature excursions; Vaccine administered after after 4 temperature excursions; No aderse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No aderse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions).    No relevant concomitant medications were reported. Vaccine was moved from freezer to refrigerator on 12/2/22. Of the ten vials in question 43 injections were given and 7 doses were wasted. No treatment medication reported.   This case contains information for the 21st of 43 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-689222 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689222:
Right upper arm bruised color very sore. The PM of 01/27/05 chills, body aches and very sore arm.
difficulties removing the tip cup to attach the needle causing the hub to loosen; had an issue with the tip cup; needle was detached, and the majority of the vaccine was administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete dose administered in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2023-2024 season) (batch number J9HA9, expiry date 30-JUN-2024) for prophylaxis. This case was associated with a product complaint.   On 07-SEP-2023, the patient received FluLaval Quadrivalent 2023-2024 season. On 07-SEP-2023, an unknown time after receiving FluLaval Quadrivalent 2023-2024 season, the patient experienced incomplete dose administered (Verbatim: needle was detached, and the majority of the vaccine was administered). On an unknown date, the patient experienced needle issue (Verbatim: difficulties removing the tip cup to attach the needle causing the hub to loosen) and pharmaceutical product complaint (Verbatim: had an issue with the tip cup).  The outcome of the incomplete dose administered, needle issue and pharmaceutical product complaint were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 08-SEP-2023 and 11-Sep-2023 The reporter stated that 5 prefilled Flulaval vaccines from the same batch had an issue with the tip cup. According to the reporter, the experience nurse had difficulties of removing the tip cup to attach the needle causing the hub to loosen. However, the needle was attached, and the vaccines were administered. Luer lok needles were use all the time. Reporter stated that during the administration of one vaccine, the needle was detached, and the majority of the vaccine was administered. No replacement at time. No information was provided for the patient. The reporter consented to follow up. Reporter stated that during the administration of one vaccine, the needle was detached, and the majority of the vaccine was administered, which led to incomplete dose administered.
Third shot experienced severe diarrhea, fever and pain in right side (liver) tremors, rashes, light sensitivity, headaches, joint pain, chronic fatigue, nausea, high liver function AST between 860 and 650 out of school for 6 months to date severe agitation, behavior change.
Sore arm at injection site began hours after (nothing terrible). Woke up the next day with mild to severe body aches, muscle soreness, joint pain and pain in my stomach/abdomen. Developed a 101 fever 24 hrs after receiving the vaccine, and continued until this morning (3/16). Vomiting multiple times in the middle of the night on 3/14. The vomiting was only a one night deal, but every other symptom that I experienced has been persistent until this morning. I feel about 80% back at the moment. Symptoms were very similar, maybe even a little more extreme, than the ones I experienced when I contracted Covid months ago, but they didn?t last as long.
24 hours after injection, sore arm that lasted a day.   day 4- lymph nodes around armpit of injection arm sore day 6 - bump on injection site still experiencing soreness on the left arm
shingles; This case was reported by a nurse via the patient assistance program and described the occurrence of shingles in a 90-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.    On 27th June 2019, the patient received the 1st dose of Shingrix .5 ml. On 28th June 2019, 1 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The batch number and expiry date of Shingrix was not reported, as the patient received vaccine elsewhere. The nurse reported that, the patient received vaccine at the pharmacy, and on the date of reporting, the patient experienced Shingles.
Patient is 6 years old and the Moderna vaccine is not approved for him. No adverse events have been reported.
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Shakiness-Medium, Additional Details: pt fell on the floor minutes after receiving her shot . she said she is sweating and have difficluty breathing and she couldnot stand on her own
Initial report received on 12 September 2013 from an investigator participating in a study under the reference number M5A11. A four-month-old female subject with no reported past medical history had received on 04 December 2009 the following vaccines: dose 2 of PENTACEL, Lot number C38481AA (route and site of administration not reported), dose 3 of Hep B, MSD lot number 1251Y (route and site of administration not reported), dose 2 of PNCV7, Pfizer lot number D92436 (route and site of administration not reported), and RV5, MSD lot number 0534Y (route and site of administration not reported) and 25 days later was found to have a bacterial sepsis due to acute otitis media. The subject has been napping at daycare and original workup was for SIDS. According to physician reviewing autopsy results states "rapidity of this overwhelmingly sepsis in an otherwise perfectly normal appearing child is quite unusual: speculated that it may have been secondary to an unknown immune deficiency which will probably never be known." The subject had received dose one of PENTACEL, lot number C3385AA on 13 October 2009. According to the investigator, discussion of potential consultation with immunology department and potential genetic testing but it was unknown whether either of these were pursued. If so, results were unavailable. No further information was available at the time of the report. The subject's outcome was fatal. The event of bacterial sepsis due to acute otitis media was not related to the trial product. Follow-up information was received on 08 October 2013 from the investigator. The subject had a past medical history of a URI on 15 December 2009 which lasted a week, nasal congestion at 20 day visit and cradle cap at 2 month well visit. According to the report, at the 20 day visit the subject had cold symptoms over the prior 3 days, no fever, not much coughing and the subject was still feeding ok and having wet diapers and stools. "Dx: congestion of nasal sinus (primary encounter diagnosis) Note: may be secondary to Upper respiratory infection". The subject had received on 13 October 2009 an intramuscular left thigh injection of PENTACEL. On 04 December 2009, the subject had received an intramuscular right thigh injection of PENTACEL, and intramuscular left thigh injection of Hep B, an intramuscular left thigh injection of PCV7 and RV5 orally. Documents held by sender: medical records and autopsy report.
Patient fell from standing position, hit head on floor, blacked out. Applied ice to back of head, had patient remain in clinic for 30 mins after this happened for observation, pt caregiver advised to take to ER if any vomiting, memory loss occured. Pt showed no symptoms prior to him getting immunization or before passing out. Parent/Guardian requesting to not continue with vaccine.
Red itchy blotches and streaks all over her body; itchy hive-like blotches; Red itchy blotches and streaks all over her body; itchy hive-like blotches; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 at 09:30 as dose 5 (booster), single (Lot number: GJS342) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Multivitamin" (unspecified if ongoing); "Acid reflux" (unspecified if ongoing); "IBS" (unspecified if ongoing). Concomitant medication(s) included: BENTYL; ELAVIL [ALLOPURINOL]; GAS-X; VITAMIN D3. Vaccination history included: BNT162b2 (DOSE 1; Lot Number: EN6203; in left arm at 01:30 PM), administration date: 21Feb2021, when the patient was 68-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2; Lot Number: EP7534; in left arm at 02:00 PM), administration date: 18Mar2021, when the patient was 68-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER); in left arm at 01:15 PM), administration date: 25Sep2021, when the patient was 69-year-old, for COVID-19 immunization; BNT162b2 (DOSE 4 (BOOSTER); Lot Number: FK9893; in left arm at 10:45 AM), administration date: 12May2022, when the patient was 69-year-old, for COVID-19 immunization. The following information was reported: RASH MACULAR (non-serious), RASH PRURITIC (non-serious) all with onset 15Sep2022 at 20:00, outcome "not recovered" and all described as "Red itchy blotches and streaks all over her body; itchy hive-like blotches". The events "red itchy blotches and streaks all over her body; itchy hive-like blotches" required physician office visit. Therapeutic measures were taken as a result of rash macular, rash pruritic.  Additional Information: The patient had no known allergies. The patient had no other vaccine in four weeks. The patient was also taking an unspecified multivitamin in two weeks. 48 hours after the injection (as reported), the patient broke out in red itchy blotches and streaks all over her body (not at the injection site) - these itchy hive-like blotches come and then fade away within the hour. Then new ones appear. This is continuing to happen every day; the day of the reporting is day 7. As treatment for the events so far, topical steroid ointment for itching was administered. The patient had not been tested for COVID-19 post-vaccination.
Information has been received from a registered nurse (R.N.) concerning her 69 year old husband with no pertinent medical history or allergies who in late June 2008, was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Merck) (lot #659409/0409X) which has been stored in the freezer in their home for about one month before it was reconstituted and given.  The freezer temperature was minus 12 degree Fahrenheit.  About a week later, the patient developed a mild, red rash and "heat" rash across his shoulders.  Unspecified medical attention was sought and no laboratory or diagnostics tests were performed.  The rash resolved in less than a week.  Follow up information was received from the R.N. who reported that her husband who at 9 AM of 12-JUL-2008 was vaccinated subcutaneously with a first dose of ZOSTAVAX (Merck) in his right arm.  There was no illness at the time of the vaccination.  Additional information has been requested.  This is one of several reports from the same source.
History of left thigh nodule after vaccines. Non-tender, should self-resolve Rx: supportive care.
One day following vaccine, c/o sore throat, achy, fever (103 degrees) was ordered a Z-PAK by her doctor.
Right arm with swelling, redness, warmth, tingling, stiffness x greater than 4 days. Pt. received PNEUMOVAX vaccine to left deltoid and influenza to right deltoid. Pt. used ice, stretching, and TYLENOL to site before contacting Physician.
On 5/11/22 I woke with a sore throat and had moderate congestion in the lungs with a cough and I am tired. No other symptoms so far.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age who was wife of an employee of the pharmacy. The patient was vaccinated with ZOSTAVAX (lot number, route and dose not reported) on an unknown date. No other co-suspects were reported. No concomitant medications were reported. The patient developed painful lesions on her leg after administration of ZOSTAVAX. It was unspecified if the patient had sought medical attention. No treatment information was reported. The outcome of the painful lesions was unknown. This is one of reports from the same source. Additional information has been requested.
This spontaneous report as received from a nurse refers to a 3 unspecified patients of unknown age and unknown gender. The 3 unspecified patients pertinent medical history was not reported. On 16-DEC-2014, the 3 unspecified patients were vaccinated with 3 doses of GARDASIL (dose/frequency: 0.5 ml) intramuscularly that underwent a temperature excursion. No adverse effect reported. No product quality complaint (PQC) was reported for GARDASIL. Additional information has been requested.
Covid arm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (Covid arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Covid arm). At the time of the report, IMMUNISATION REACTION (Covid arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided Treatment medication was not provided by the reporter  Patient had experienced Covid arm from The Moderna
patient got a stroke from her swine flu shot; lump traveled to her brain and burst; injection site developed a golf ball size lump; Initial information was received on 08-Oct-2020 regarding an unsolicited valid serious case from consumer or non-health care professional.  This case involves a female patient (age unspecified) who had stroke (cerebrovascular accident) and injection site developed a golf ball size lump (vaccination site mass) which traveled to her brain and burst (intracranial mass), while she received INFLUENZA VACCINE (MONOVALENT) [swine flu shot].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (MONOVALENT) (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient had a serious stroke (cerebrovascular accident) (unknown latency) following the administration of INFLUENZA VACCINE (MONOVALENT). This event was assessed as medically significant. On an unknown date, the patient developed a non-serious injection site developed a golf ball size lump (vaccination site mass) which traveled to her brain and burst (intracranial mass), (unknown latency) following the administration of INFLUENZA VACCINE (MONOVALENT).   Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  On an unknown date, the patient had recovered from vaccination site mass (reported as disappeared) and at the time of reporting, the event outcome for stroke and intracranial mass was unknown .   There will be no information available on the batch number for this case.; Sender's Comments: This case involves a female patient (age unspecified) who experienced cerebrovascular accident, vaccination site mass and intracranial mass after vaccination with INFLUENZA VACCINE (MONOVALENT) [swine flu shot]. The time to onset was unknown. Further information regarding concurrent condition during vaccination, previous vaccination and tolerance, laboratory investigations ruling out other etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Initial report received on Oct 03 2005 about a consumer report. A 21 year old female stated that she received Meningitis vaccine and Hepatitis B vaccine #1 on Oct 10 2003, Hepatitis B vaccine #2 on Jan 22 2004 and Hepatitis B vaccine #3 on Dec 0 2004, no lot numbers were provided. She was vaccinated at her college student health center. Then, in April 2005, she had arm and leg weakness and was hospitalized from April 21 2005 in her college town and transferred to another hospital in Atlanta from May 14 2005 to May 19 2005. She was then in a rehab hospital from may 19 2005 to June 14 2005. She said she had a GBS like illness. She is now wheelchair bound and is unable to lift her arms. Her immunization record have been requested and a VAERS report will be submitted.
pt broke out w/chicken pox on 12MAY96 & cont to have further eruptions on following days;seen @ MD office 14MAY96;
Shot administered at 11am - Had light lunch & Boss's day party at 2pm -> (cake & raspberries) -> started to feel tightness at 2pm - then 2:30 talked to friend on phone. - After hanging up around 2:35 &  called someone back - then called 911.
After H1N1 vaccine, awoke with severe R forearm pain radiating down arm to hand. has had decreased elbow/wrist range of motion & median nerve numbness, swelling since 12/9/09 when vaccine was administered.
Headache, dizziness, disorientation, upset stomach.  Headache not resolved with tylenol.  Symptoms resolved after 36 hours.
Patient was given vaccination, was fine after the vaccination, then complained of muscle soreness. Patient then went  pale and fainted, hitting his head on pharmacy counter. Regained consciousness and was A and O x 3. Left with paramedics for precautionary reasons.
Headache, neck, shoulder and chest muscle aches started about 20 hours after the shot along with swollen lymph node in left arm pit.
by history pt had genl tonic clonic sz lasting 3-5 mins w/post ictal unresponsiveness x 5-10mins; no apnea; nl behavior 4 exam w/in 4 hrs; never devel fever; no hx trauma, toxin exposure, biles, travel other than recent move from Germany;
Shivering (probably due to a fever??), severe headache, nausea, vomiting, pain as well as redness and swelling of the injection site, muscle soreness, tiredness. In trying to figure out what was going on with me, I looked up possible side effects as I woke to serious shivering in the early morning hours while sleeping under my electric blanket (this was almost exactly 12 hours after the SHINGRIX shot).  I knew that was completely unusual. At that same time my headache resembled migraine headaches that I used to have years ago. The headache faded after about 24 hours as did the shivering. My injection site was red, sore, and swollen which actually seemed to worsen before it improved over the next 5 to 7 days. The nausea hit me by morning after the afternoon SHINGRIX shot, and the only vomiting I experienced was about 24 hours after receiving the SHINGRIX vaccine. However, my appetite did not return until 5 days, almost to the hour of having the SHINGRIX shot. Please know that I had these side effects only with the second of the two SHINGRIX shots. Having only a sore arm and slight redness with the first injection almost 6 months prior, I was totally blindsided by the side effects I experienced as I thought I would have just the same type of reaction (very minimal) as I did to the first of the two SHINGRIX shots! I did not seek medical help for the side effects once I realized that the things I was experiencing were things other people had experienced with the SHINGRIX vaccine, however, it would have been helpful to know what I might experience before getting the second shot!  I have warned others about it after my experience.