chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st Shingrix on 25May2018, 2nd will be today (01Aug2022); This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (the patient received 1st dose of Shingrix by intramuscularly on unknown arm on 25th May 2018).   On an unknown date, the patient did not receive 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 Information: GSK receipt date: 1-Aug-2022 Reporter comment:  The reporter stated that he was not told he need a second Shingrix vaccine to complete the series. The reporter also mentioned would go today for his second vaccine. The reporter did not gave consent to follow up. Additional Supportive Information: The patient was not told they need a second Shingrix vaccine to complete the series, which led to incomplete course of vaccination. This case was linked to the case US2022AMR114084, reported by the same reporter for her wife.; Sender's Comments:  US-GSK-US2022AMR114084:Same reporter
STARTED ON 1/15/2021 4PM WITH NUMBNESS, TINGLING RIGHT UPPER EXTREMITY, AXILLLARY EDEMA AND INDURATION WITH SEVERE PAIN AND ELEVATED TEMPERATURE IN AREA, DIFFICULTY WITH ADDUCTION OF ARM,  PAIN RIGHT SHOULDER WITH SWELLEING AND RIGHT TORSO PAIN,
I was getting better from having a cold. At the time of my booster shot, I had a cough and migrane only. After taking the booster shot, I've been coughing constantly. Sometimes it'll be a light cough. Sometimes my cough would be a constant choking like cough. It's been a month and a half and I'm still coughing.
itching, itched; Break out in hives/hives were red and itched/ hives are itched; and burned and were hard and raised patches.; that felt like a pin was pricking him; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received in 2002).   On 6th May 2022, the patient received the 1st dose of Shingrix. In May 2022, 76 hrs after receiving Shingrix, the patient experienced pruritus, hives, burning sensation and pins and needles. The patient was treated with prednisone and antihistamine (Antihistamines). On an unknown date, the outcome of the pruritus, hives, burning sensation and pins and needles were not recovered/not resolved.   It was unknown if the reporter considered the pruritus, hives, burning sensation and pins and needles to be related to Shingrix.     Additional Information: GSK Receipt Date: 13-MAY-2022 Reporter's Comments: The patient reported case for himself. The patient received Shingirx in the left arm. About 76 hours later, he started itching and began to break out in hives. The hives were red and itched and burned and were hard and raised patches that felt like a pin was pricking him. They were located on the injected arm (left arm) and on the left calf. The patient was treated with antihistamines and got a prescription of a 6 days taper of prednisone. This event was not yet fully resolved. He stated that if he did not take the antihistamines then he continued to have itching. The reporter did not have the lot number of the injection that he received. The reporter said that he called control regarding this and they advised him to go online to fill out a VAERS form, but because he did not like putting his personal information on websites he did not. The reporter consented to follow up.
Palsy. Drooping of lift side of face and twitching of eye and left eye doesn?t close. About a week and a half
Rash on her left upper arm that is descending down to her elbow. Rash extending downward. Measures approximately 18 cm x 6-8 cm in width. No blistering present. Swelling noted at injection site
Vaccine was pulled from the freezer to the fridge on 1/5/2023. There were no temperature excursions, however when vaccine was given the vaccine was in the fridge outside of recommended duration.
Patient was scheduled to receive 2nd dose of Moderna.  Pt given Pfizer vaccine in error.  No adverse reactions
inadvertently administered 2 bivalent booster doses to a patient one week apart; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXTRA DOSE ADMINISTERED (inadvertently administered 2 bivalent booster doses to a patient one week apart) and NO ADVERSE EVENT (No adverse event) in an 84-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     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, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (inadvertently administered 2 bivalent booster doses to a patient one week apart) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (inadvertently administered 2 bivalent booster doses to a patient one week apart) and NO ADVERSE EVENT (No adverse 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 adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (inadvertently administered 2 bivalent booster doses to a patient one week apart).    No concomitant medications were reported.  The reporter asked for recommendation that needed to be done in this situation.  No treatment medications were reported.
swollen arm; sore arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swollen arm), VACCINATION SITE PAIN (sore arm) and HEADACHE (Headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism since 1995, High cholesterol since 1999 and Drug allergy. Concomitant products included SIMVASTATIN (ZOCOR) for Cholesterol, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, TRAZODONE for Insomnia, CALCIUM for Osteopenia, MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Oct-2021, the patient experienced VACCINATION SITE SWELLING (swollen arm), VACCINATION SITE PAIN (sore arm) and HEADACHE (Headache). On 29-Oct-2021, HEADACHE (Headache) had resolved. At the time of the report, VACCINATION SITE SWELLING (swollen arm) and VACCINATION SITE PAIN (sore arm) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported.   This case was linked to MOD-2021-372786, MOD-2021-365112 (Patient Link).
Initial report received from a consumer via Novartis employee on 10 May 2010: This patient was vaccinated with MENVEO (batch number: no: 091991, 0290011), (dose: unknown) intramuscularly on 05 May 2010. The patient was administered MENVEO that was not reconstituted before administration and only the liquid portion was administered. No adverse event had occurred due to this inadvertent administration.
This initial non-serious spontaneous case, was received on 19-Sep-2017 from other health professional, concerns 33-year-old, adult, female patient. On 18-Sep-2017, the patient was inadvertently administered with expired AFLURIA (dose: 0.5 ml, expiry date: 30-Jun-2016, route of administration, anatomical location and batch no: not reported (coded as expired product administered). The outcome of event was unknown. The reporter assessed this case as non-serious.
1) I tested Positive for Covid-19 on December 28, 2020 2) I got the the vaccine on April 23, 2021 3) Before receiving the vaccine I noticed ringing in ears one time.  I thought it was strange because I hadn't had that in a long time that I could remember. 4) After taking the vaccine within 2-4 days I noticed pressure in my ears that tended to cumulate to ringing when the pressure got high enough. 5) After a few days there has been no more ringing but there is still pressure, this is particularly in my left ear. 6) Along with the pressure it feels as though fluid runs out of my left ear.  I have used peroxide twice to try and clean my ears since then.  I have not swam since summer or early fall.  This feels slightly similar to an ear infection but different.  Not as painful as much as annoying. 7) I have had both covid and the 2nd dose so I feel as though there is no real need for me to get a 2nd dose.  Most data suggest for recovered covid-19 only 1 dose could possibly be sufficient and I do not see a benefit/risk of receiving a 2nd dose if it could possibly make these symptoms worse, when I have already had a 1st dose along with the virus itself not that long before. 8) Though I have not had any other vaccinations in the past month, in the past year (since June 12 of  2020) I have had the following: 2 doses of Hepatites A, Influenza 0.5 ml, Tetanus depntheria peitussis, Oral typhoid 4 capsules, Vaxchora dose, Menreo , Yellow fevor Sanofi pasteur, Polio sanofi pasteus, A second flu vaccine in October.  I apologize if I spelled things wring I am trying to read cursive handwriting on an immunization card.
Dx'd as Cellulitis in ER however my review of  this case and other cases that arrived at same time leads me to believe that it was vigorous PVAX local reaction.
pt recvd vax & exp redness, swelling, hardness, & itching @ the inject site;
1 patient got a result of (-) IGG and (+) IGM and didn't receive the 2nd dose of the vaccine; 1 patient got a result of (-) IGG and (+) IGM and didn't receive the 2nd dose of the vaccine; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number was not reported), dose 1 via an unspecified route of administration on an unspecified date as 0.3 mL, (SINGLE DOSE) for COVID-19 immunization. The patient medical and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. Physician stated that he has 3 patients who received their Pfizer Covid vaccine and had their antibody tests done. 1 patient got a result of (-) IGG and (+) IGM and didn't receive the 2nd dose of the vaccine while the other 2 patients got a result of (-) IGG and (-) IGM which was taken 3 weeks after their 2nd dose. Wants to know what this means and what does he need to do about it. Escalating to Second Line for further research. Preferred method of contact is through phone. The patient underwent lab tests and procedures which included blood immunoglobulin g: (-), blood immunoglobulin m: (+) on unknown date. Outcome of the events was unknown on an unspecified date. The reporter considered the events as non-serious.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021162118 same reporter, drug and event/different patient;US-PFIZER INC-2021162117 same reporter, drug and event/different patient
3-4hr p/vax pt exp paresthesia lt side aches, lt shoulder pain, gen malaise & not feeling well;this all lasted 3-4 days;
Onset date 08/20/2022, patient reported sore throat, lesions on the back of his throat and fatigue. He stated that on 08/22/2022 he seek medical attention from pcp and urgent care. Patient tested + for monkeypox on 08/23/2022. F/U with pcp, recommneded isolation for 21 days, no medication was prescribed as per patient. Phone call to patient 09/13/2022, reports his skin is healed and eas cleared out of isolation from pcp. Patient reports he has no pre existing conditions.
Swelling and tenderness of lower 1/2 of left upper arm. Seen in emergency room 12/12/2007 and treated with cephalexin for possible cellulitis. Seen 12/14/2007 in office for follow-up. Still has 8cm area of swelling with mild firmness distal outside of left upper arm. No tenderness at all, no redness.
Swollen Lymph Node behind Right ear lasted 5 weeks. Fever of 101 degrees lasted 3 days. Office visit for examination required.  Second office visit several weeks later was scheduled and completed for follow up and lymph node check.
FIRST DAY, ITCHY INJECTION SITE TURNING RED ACROSS ENTIRE UPPER ARM. LASTED 3 DAYS, ARM SWELLED, TENDER TOO SORE TO TOUCH. THEN AT DAY 7 THE ITCHING STARTED AGAIN, ARM SWELLED, ENTIRE UPPER ARM SWELLED, RED, RAISED BUMPS.
inherited Autosomal Dominant Neurological Essential Tremors; having the same condition and when he got his COVID shot his tremors worsened; This is a spontaneous report from a contactable consumer or other non hcp. A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history included inherited Autosomal Dominant Neurological Essential Tremors (not Parkinson's). The patient's concomitant medications were not reported. On an unspecified date, the patient experienced inherited autosomal dominant neurological essential tremors, having the same condition and when he got his COVID shot his tremors worsened. Therapeutic measures were taken as a result of events. The seriousness of the events was serious and medically significant. The outcome of the events was unknown.  No follow-up attempts are needed. No further information expected.
Patient was hospitalized for two days for bowel intussusception and pain (proven by barium enema). Patient had bloody bowel movement and pain. 06/12/07-DC Summary received for DOS 5/6-5/7/07-DC DX:Ileocolic Intussusception. S/P Barium Enema Reduction. Two day history vomiting and subsequent bloody stools
Post vax, pt had 6 hours of inconsolable crying, reported by mother. Intermittent crying X 2 days after initial episode.
Hours after injection my upper arm/shoulder was in 8/10 pain on scale of 1-10. Limited range of motion, unable to lift arm 3 inches without pain. extremely tender, tingly. Swollen from elbow up.
Case number PHEH2013US002371, is a spontaneous report initially received from a nurse on 12 Jan 2013 with a follow-up received on 12 Feb 2013: This report refers to a 1-year-old female patient (infant). Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: A11078/X11078) intramuscularly at a dose of 0.05 ml on 22 Jan 2013. No adverse event was reported, following this medication error (inappropriate age at vaccine administration). Follow-up received from the nurse on 12 Feb 2013: Updated patient demographics, batch number and dose for MENVEO and event (vaccine underdose).
This spontaneous report was received from a Registered Nurse refers to a patient of unknown age and gender. The reporter reported that the patient was vaccinated with GARDASIL (Lot # unspecified) Intramuscular injections, first dose "in 2011", the second dose "in 2012" and the third dose in October 2013 (dose, route and indication unspecified). No adverse effect reported. Outcome of the event was not reported. Additional information is not expected.
This case was reported by a healthcare professional and described the occurrence of swelling injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX QUADRIVALENT (GlaxoSmithKline). On 16 September 2014, the subject received unspecified dose of FLUARIX QUADRIVALENT (.5 ml, unknown arm and route). On 16 September 2014, immediately after vaccination with FLUARIX QUADRIVALENT, the subject experienced swelling, redness, bump, all at the injection site. The subject used a heavy duty Band-Aid for 10 minutes to cauterize the bleeding after the injection. At the time of reporting, the events were resolved. This case was associated to a product complaint. The reporter noted that the last 2 days, they had given 170 FLUARIX vaccine injections and they had seen a higher number of injection site reactions. This is one of the 7 cases reported by the same reporter for the same vaccine and same events. Follow-up information received 25 September 2014: QUAL number updated.
Received Via Employee Immunization.  Developed shortness of breath and a dry, hacking cough.  Treated with Diphenhydramine 50mg IM and Methylprednisolone 80mg IM.  Symptoms resolved
This spontaneous report was received from a female consumer of unknown age regarding herself. On an unknown date in 2014 (stated as a couple of days ago), the patient was administered with a dose of ZOSTAVAX. On an unknown date in 2014, the patient was sore at the injection site and also developed a little rash around the injection site. The outcome of sore at the injection site and little rash around the injection site was reported as not recovered. Additional information has been requested.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition or medical history was reported. On 12-JAN-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # K010016, dose and route of administration was not provided). No concomitant therapy was reported. No adverse symptoms were reported. The pharmacist stated that the vaccine in question did not had any previous temperature excursions. The outcome of the event was unknown. No product quality issue was reported. Additional information has been requested.
Headache within an hour. Severe Vomiting and diarrhea about 5-6 hours later. Half an hour after that event, repeat of vomiting and diarrhea.
Very itchy skin. Dermatologist ordered a 1% cream with cortisone. Dr also said to take Benadryl or Zertec . Still experiencing itching.
hot and cold flashes; he is feeling like he is coming down with the flu; couldn't think straight; fatigue; his muscles hurt; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (hot and cold flashes), INFLUENZA LIKE ILLNESS (he is feeling like he is coming down with the flu), THINKING ABNORMAL (couldn't think straight), FATIGUE (fatigue) and MYALGIA (his muscles hurt) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 19-Sep-2020.    On 21-Apr-2021 at 10:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (hot and cold flashes), INFLUENZA LIKE ILLNESS (he is feeling like he is coming down with the flu), THINKING ABNORMAL (couldn't think straight), FATIGUE (fatigue) and MYALGIA (his muscles hurt). On 23-Apr-2021, FEELING OF BODY TEMPERATURE CHANGE (hot and cold flashes), INFLUENZA LIKE ILLNESS (he is feeling like he is coming down with the flu), THINKING ABNORMAL (couldn't think straight) and MYALGIA (his muscles hurt) had resolved. At the time of the report, FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were taken.
Redness, edema, pain left deltoid area tender to touch, warm to touch.  Treated with TYLENOL, BENADRYL with relief.
had immun afternoon of 19MAY94 about 3PM on 21MAY94 started screaming lasted 1 hr taken to ER still screaming in ER; calmed down in 10-15mins once seen; temp taken ER no other tx or rx given; cried off & on for rest of noc; went to sleep;
03/28/01, injection site red and swelling. Full ROM. Cold compresses. On 3/29/01, treated with diphenhydramine 1 1/2 tsp every 6-8 hours.
Next day, patient woke up and she told mother she was not feeling good and felt sore.  Patient was tired, sleepy, and had no appetite.    Parent noticed she was breathing heavily when sleeping  as if gasping for air but it was only lasted for a couple of minutes and went away.    On Saturday, rash evolved and worsen.  Parents contacted the doctor via email; told to use ice packs and give patient Zyrtec. Parents told that symptoms would subside over 48 hours. By evening, vaccine area was swelling, seemed to be retaining fluid and was not improving.  Parents contacted nurse, affected area was 4 inches wide, and directed to ER.  Patient was diagnosed with cellulitis and prescribed antibiotics (Cephalexin); patient released.  Patient will follow-up with PCP to see if symptoms improving.  So far, there is some improvement.  Received Flu vax in early October.
This spontaneous report was received from a healthcare worker regarding an unknown number of patients. The patients demographics were unknown. There was  not pertinent medical history and drug reaction or allergies of the patients reported. The reporter stated on an unknown date several clients were vaccinated with PNEUMOVAX23 (dose, route, product lot and expiry date was not reported) that had been improperly stored. No adverse effect reported. There was no product quality complaint involved. This is one of the several reports from the same reporter. Additional information has been requested.
Couldn't get warm, he kept saying he was cold, did not have a fever but his body felt normal temperature. He said he kept getting really sharp pains in his foot. When he stood up he was extremely pale and was very shakey and had awful tremors. He also had a hard time walking. Haven't gone to a doctor, he refuses to go.
Extremely painful, very limited mobility and range of motion in left arm.  Difficulty with dressing , showering, hair washing, etc.  Pain at night when turning over - awoke with sharp, piercing pain - difficulty getting out of bed.   Searched on Internet for information and discovered that likely frozen shoulder from vaccine.  Researched additional information and physical therapy exercises.  Did these at both my office at work and at home.  Very gradual improvement - it has been about 1.5 years and range of motion has improved and pain lessen.....about 90% improved, still feel pain when lifting arm.
Information has been received from a Nurse Practitioner (N.P.) concerning herself with no pertinent medical history and with penicillin allergy who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) subcutaneously.  There was no concomitant medication reported.  It was reported that on an unspecified date she developed an injection site reaction after receiving ZOSTAVAX (Merck).  She developed a 6 inch diameter of redness at the site.  It was also reported that she experienced pain and soreness at the site.  The patient did not seek medical attention.  There were no laboratory diagnostic tests performed.  It was reported that the patient had recovered "2-3 weeks after the vaccination".  No further information is available.