chrisvoncsefalvay/vaers-outcomes huggingface dataset:
nurses has administered ACTHIB that has been reconstituted with sterile water instead of the saline diluent, with no reported adverse event; Initial information received on 01-Aug-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 1 year old female patient who was administered HIB (PRP/T) vaccine [ACT-HIB] that has been reconstituted with sterile water instead of the saline diluent, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 7V (CRM197) (Prevnar) for Prophylactic vaccination (immunization).  On 01-Aug-2023, the patient received 0.5 mL dose 4 of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (batch number: UJ803AA; expiry date: 13-Aug-2023) via intramuscular route in the right thigh for Immunization that had been reconstituted with sterile water instead of the saline diluent, with no reported adverse event (product preparation error) (same day latency) following the administration of HIB (PRP/T) vaccine.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event nurses has administered acthib that has been reconstituted with sterile water instead of the saline diluent, with no reported adverse event.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
More redness, less swollen on the side of injection site on left thigh. More swollen, hardness, less redness around injection site on the right thigh Ibuprofen is prescribed for fever as needed.
Left leg numbness; This is a spontaneous report from a contactable nurse (patient). A 57-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek9231), intramuscular (left arm) on 23Dec2020 at 15:00 at a single dose for COVID-19 immunization. Medical history was not reported. The patient had no known allergies (NKA). The patient had no COVID prior vaccination. The patient is not pregnant. Concomitant medications included unspecified medications administered in two weeks; no other vaccines received in four weeks. The patient experienced left leg numbness on 25Dec2020 at 16:00. Treatment done for the event included tests and procedures which included magnetic resonance imaging (MRI) and X-ray-both with unknown results on an unknown date. The event resulted in doctor or other healthcare professional office/clinic visit. The patient had not tested post vaccination. The event was resolving.   No follow up attempts are possible. No further information is expected.
Client was given a Pediatric dose of Hep B instead of an Adult dose of Hep B. Client schedule 11/30/22 for Heplisav series of 2 to get fully up to date on Hep B and Hep A instead of choosing to correct and complete Hepatitis B only series.
Syringe malfunctioned during the process, and I wasn't able to receive a full dose; wasn't able to receive a full dose; Was administered a booster to help make up for what was lost down my arm; This spontaneous case was reported by a consumer and describes the occurrence of DEVICE CONNECTION ISSUE (Syringe malfunctioned during the process, and I wasn't able to receive a full dose), ACCIDENTAL UNDERDOSE (wasn't able to receive a full dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Was administered a booster to help make up for what was lost down my arm) 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 10-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, the patient experienced DEVICE CONNECTION ISSUE (Syringe malfunctioned during the process, and I wasn't able to receive a full dose), ACCIDENTAL UNDERDOSE (wasn't able to receive a full dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Was administered a booster to help make up for what was lost down my arm). On 10-Dec-2021, DEVICE CONNECTION ISSUE (Syringe malfunctioned during the process, and I wasn't able to receive a full dose), ACCIDENTAL UNDERDOSE (wasn't able to receive a full dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Was administered a booster to help make up for what was lost down my arm) had resolved.            No concomitant medications were reported.  Treatment information was not provided. Patient received first vaccine shot and the syringe malfunctioned during the process and was not able to receive a full dose. So to combat the situation an additional dose was administered to make up for what was lost down the arm.
Pt recvd 1st dose of vax w/no noted problem; pt recvd 2nd dose of Hep B vax 18AUG92 & w/in an hr following vax pt exp sore arm w/pain @ the inject site; sx resolved w/in 24 hrs; No further details were provided;
The patient has a history of fainting after shots.  She became warm and faint after receiving the injection.  She was very weak and put her head on the table for about 10-15 minutes until she was feeling better.
VACCINE ADMINISTERED 12 HOURS POST  EXPIRATION DATE; This spontaneous report received from a pharmacist concerned a 54 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient experienced drug allergy when treated with glatiramer acetate for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070 expiry: 25/MAY/2021) dose was not reported, administered on 26-MAY-2021 12:09 for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, the subject experienced vaccine administered 12 hours post expiration date. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine administered 12 hours post expiration date was not reported. This report was non-serious.
A one inch by 1 and 1 and 1/2 inch red spot appeared.  The arm was swollen and sore to the touch and the red area expanded to the size of a baseball within 24 hours.  This vaccine was a varicella booster.  While the redness began to dissipate within 48 hours the arm remained swollen and the injection site was extremely itchy for the next 48 hours.
Information was received on 20-APR-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. It is complained and alleged that the patient was inoculated with a dose of ZOSTAVAX vaccine on or about 21-JUL-2014 at a pharmacy, as recommended for adult routine health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 25-AUG-2015, the patient was treated by a physician's assistant at an urgent care center for a painful rash that was diagnosed as a severe case of shingles.  Although the shingles virus is an incurable condition, the patient was prescribed acyclovir (manufacturer unknown) for the management of her symptoms.  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. Additional information has been requested.
Muscle spasms throughout body but especially in hands feet and esophagus.. possible cardiac spasms that lead to brief loss of consciousness
Developed tinnitus in both ears the day after the injection, and it has continued (now 3 days post injection). It is a low grade buzzing or humming sound.
31 weeks pregnant; sore arm after administration of the vaccine; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (31 weeks pregnant) and VACCINATION SITE PAIN (sore arm after administration of the vaccine) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 12-Jul-2020 and the estimated date of delivery was 13-Apr-2021. On 13-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (31 weeks pregnant) and VACCINATION SITE PAIN (sore arm after administration of the vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirtieth week of the pregnancy.  On 13-Feb-2021, EXPOSURE DURING PREGNANCY (31 weeks pregnant) had resolved. At the time of the report, VACCINATION SITE PAIN (sore arm after administration of the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment or concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Feb-2021: No specific follow-up information recorded.
Dizziness, described as the room and objects were spinning, began approximately five hours after receiving vaccine.  Subsequently, he continues to report spinning/dizziness, headaches on a daily basis.  Has also had a few days with intermittent stomach ache (seems related to motion sensitivity) and can no longer tolerate swinging on a playset.   Had a physician visit on 1/25/22 which revealed only non-purulent fluid in left ear, no ear infection.   Flonase nasal spray prescribed once daily and use of a humidifer, but no improvement, and actually has had increase in headaches, now occurring sometimes immediately upon waking in the morning.  Use of Tylenol helps reduce or eliminate headache, but the appearance of objects spinning and feeling dizzy never fully goes away, including with the use of Meclizine (which has now been added PRN x ~ 2 weeks).  Will see ENT specialist this week, then possibly neuro if ENT finds no cause for continued dizziness.  I strongly feel the vaccine caused the dizziness, as this has continued for over six weeks and began day of vaccination.  We opted not to receive any further vaccine doses.
Patient has developed a raised red area about 3 inches in length and 1 inch wide around injection site.  Patient has never had a reaction in the past.  Patient also states feeling sick to stomach and feeling a little unbalance, but is unsure if this is related to the vaccine.
muscle pain; headache; stomach discomfort/upset stomach; feel bad/side effects; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 52-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced muscle pain, headache, stomach discomfort and feeling bad. On an unknown date, the outcome of the muscle pain, headache, stomach discomfort and feeling bad were unknown.   It was unknown if the reporter considered the muscle pain, headache, stomach discomfort and feeling bad to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. After receiving the Shingrix vaccine the patient experienced Having muscle pain, head ache, stomach discomfort on day 2. The patient asked how long do shingles vaccine side effects last. The patient also asked how long should I wait to get the Flu vaccine after receiving the SHINGRIX vaccine.
The second week of June I began having sinus issues.  Coughing began a few days later.  I then felt like I had been hit like a truck.  I was super tired and didn't feel like going anywhere.  As of today, I have the cough.  In late June I was diagnosed with sinus infection and pneumonia on June 21st.  I tested positive for COVID-19 on June 22nd.  I received the antibodies on June 24th.  After this I had the first round of antibiotics for the pneumonia, Augmentin and then Doxycycline, Prednisone and Singulair.  I am still on the antibiotics and I began to feel better but still have the cough.  Unsure if the cough is pneumonia related or COVID-19 related.
PMH:  HTN, DMT2, prostate CA; to ED with increasing weakness, SOB, cough (x8dys); Positive for COVID; taking antibiotics and steroids from PCP; initially on NRB; AHRF; O2 sats decreased and pt placed on BiPAP; given broad-spectrum antibiotics and baricitinib; DNR/DNI; pt's condition worsened;  family declined hospice; pt died in the hosp
This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.  In September 2018, the patient received the 1st dose of Meningococcal B vaccine. In September 2018, less than 2 weeks after receiving Meningococcal B vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to Meningococcal B vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient received Meningococcal B vaccine last week from the date of reporting. The patient experienced pain in his arm. The patient was due for the next dose in a month.
Localized inflammation with a very tender, burning/itching sensation. Area of inflammation about the size of a fist near injection site. OTC Claritin & ibuprofen were administered once on 4/20/21 to alleviate symptoms. Internet search coined this as COVID arm. Inflammation and other symptoms subsided about 48 hours after starting. At time of reporting, 4/25/21, a darkened spot of the inflamed area remains but no additional symptoms have appeared.
swelling, redness, fever 101 x 24hrs ice to site APAP given for fever;
Slept good for 8 hours but Very tired on morning of April 23 layed down slept for 4 hours after breakfast. Woke up with severe cramping at 4 am on 24 April in the left calve.  Right tricep was very sore. Vision was very blurry and had cold sweats. Night Vision was very bad.
He did not feel good with first two Pfizer COVID vaccines; Low grade fever; muscle aches; nausea; headache; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 52 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 16Dec2020 (Lot number: EH9899) at the age of 52 years as dose 1, single and intramuscular, administered in deltoid right, administration date 08Jan2021 (Lot number: EL3246, Expiration Date: Apr2021) as dose 2, single for covid-19 immunisation. Relevant medical history included: "overweight" (unspecified if ongoing); "he dose not smoke" (unspecified if ongoing). There were no concomitant medications. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "He did not feel good with first two Pfizer COVID vaccines"; PYREXIA (non-serious), outcome "unknown", described as "Low grade fever"; MYALGIA (non-serious), outcome "unknown", described as "muscle aches"; NAUSEA (non-serious), outcome "unknown", described as "nausea"; HEADACHE (non-serious), outcome "unknown", described as "headache". Additional information: He did not feel good with first two Pfizer COVID vaccines, but did not feel out of normal from what was explained would happen. He had a Low grade fever and muscle aches and nausea and headache. He was just overweight, but no medical conditions.
felt a strong pain in the chest; injection site was color purple; injection site was color red, swollen and with pain; injection site was color red, swollen and with pain; injection site was color red, swollen and with pain; This is a spontaneous report from a contactable consumer (patient).  A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number not reported, via an unspecified route of administration from 14Jan2021 to 14Jan2021 as SINGLE DOSE for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. The patient stated that 2 days after the administration, the injection site was color red, swollen and with pain; 3 days after the administration the injection site was color purple; and 4 days after the administration she felt a strong pain in the chest. The outcome of the events was unknown.  Information on lot/batch has been requested.
Patient was vaccinated woth PNEUMOVAX 23 and pneumococcal vaccine on 17-DEC-2013 and 01-JAN-2015; This spontaneous report was received from a physician via immunization record from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS# 2110USA004749 ), concerning a 68-year-old male patient. On 17-DEC-2013, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 milliliter, intramuscularly, in the right deltoid, as prophylaxis (lot number J009689 has been determined to be valid for pneumococcal vaccine, polyvalent (23-valent), expiration date reported and establish as 29-JAN-2015) (strength was not reported) and on 01-JAN-2015, pt was vaccinated with an unspecified pneumococcal vaccine  (manufacturer unknown) (strength, dose, route of administration, anatomical location, indication, lot number, and expiration date were not reported) (inappropriate schedule of product administration).; Sender's Comments:  US-009507513-2110USA004749:
Patient was administered a 2nd dose of Janssen COVID-19 vaccine. He denied any previous dose. First dose was administered 5-25-21 with an additional dose administered 6-23-21.
She got her vaccine, she did not have anything that day, but the next day she started feeling itching, like she had gotten bit by something.  She saw and felt her skin and felt little bumps that was coming under her skin.  Then they appeared then it turned into the bumps came together and turned into a puddle, and then was a big blob of them.  This was on her abdomen, upper breasts.  She then had one that was on her leg/upper thigh in her panty-line area.  Yesterday and today it was on her abdomen.  She also had one on her upper thigh and cheek. She did not have any reactions prior to the vaccine, did not use any different or new skin products or soaps that would cause this reaction.  She put cortisone cream to go on the spots/hives.  They are flaming red, and tried baths and got the cream, which has helped some.  She had a similar reaction to Penicillin in the past, but has not been on any recent antibiotics.   She tried calling her doctor, but going to keep trying to let them know.    She has had all four of the COVID vaccines and had no reactions to any of those.
I suffer from neuropathic pain  in both my feet at night in bed. It is alleviated  by Voltaren or Icy Hot spray. This exaggerated pain in my feet had me up the entire night and nothing relieved it. I had to walk around and try to ease the pain  but nothing gave me any relief. At 6am I took 2 1/2 gr of Valium and finally fell asleep for 3 hours. I was much better in the morning.
Started experiencing arm pain three hours after vaccine. Around 11pm, I woke up not feeling well. Vomitting liquid all night/morn, fever of 100.5, chills , headache. Fever broke the evening of 10/6/20. Feeling fine today but still experiencing a sore arm.
Shot 2: Flu-like symptoms: exhaustion, headache, dizziness/light headed, nausea, congestion, chest tightness from Saturday 4/10 through the present (4/12 at 1524 EST). Rest, cold medicine, and restricting movement have been helpful.
I had Bells Palsy five years ago and had a flare up after the shot side of face got light and tongue and lips felt like pins sticking in them. Still having problem.
Information has been received from a registered nurse concerning a patient (age and gender not reported) who was vaccinated with the complete Gardasil series (lot # unknown) 0.5 mL midway above the arm by a medical assistant at another facility. The patient developed a hard lump for awhile after the injections (time and dose unspecified). The registered nurse did not have any additional information about this patient as it his not  her patient. The nurse was consulted about the adverse experience from another health care professional. The outcome of this report was not reported. No other details were given. Additional information has been requested.
Couple of hours after the vaccine I got a fever I had a fever on 3/13/2021 & 3/14/2021. I've been through menopause & on 3/15/2021 I got my period after 18 month not getting it. It lasted for 5 days. I seen my on 3/16/2021 and she did an internal exam & she did say it appeared to be a regular period & she ordered additional tests.
exrutiating pain in upper arms; not been able to raise arms; This case was reported by a consumer and described the occurrence of pain in arm in a 54-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th May 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pain in arm and mobility decreased. The patient was treated with analgesic, nos (Pain Medication). On an unknown date, the outcome of the pain in arm and mobility decreased were unknown.   It was unknown if the reporter considered the pain in arm and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had not been able to raise arms without excruciating pain in upper arms. The reporter just being put on pain medication. The reporter wants to know if this was permanent.