chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26-AUG-2023 and 27-AUG-2023 to adult patients, instead of the usual 0.5 mL dosage; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26-AUG-2023 and 27-AUG-2023 to adult patients, instead of the usual 0.5 mL dosage) and NO ADVERSE EVENT (No adverse event) in a 58-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7664B) for COVID-19 prophylaxis.     No Medical History information was reported.    In August 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In August 2023, the patient experienced ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26-AUG-2023 and 27-AUG-2023 to adult patients, instead of the usual 0.5 mL dosage). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26-AUG-2023 and 27-AUG-2023 to adult patients, instead of the usual 0.5 mL dosage) 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 ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26-AUG-2023 and 27-AUG-2023 to adult patients, instead of the usual 0.5 mL dosage).    No concomitant medications were reported.  No adverse event was reported for patient.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-738766 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 29-Aug-2023: Live significant follow-up received contain: Patient age, initials, gender updated and new reference numbers added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738766:Patient 1 (Master Case)
This patient was accidently given an expired vaccine that was leftover from a previous Covid Vaccine clinic.  Patient has not reported any adverse reactions.
Paleness, vomiting, lethargic, breathing difficulties, sunken eyes, listless. Baby was brought to hospital, they then transferred her by ambulance to another facility. They kept her over night to watch her. They did tests and only found that she had Rhino-virus (cold). I told them she had her shots the day before.  4/22/09 ER record received for DOS 12/7/09 with dx: ALTE.  Rhinovirus. Pertussis test pending. Pt presented after episode of emesis, gagging with pallor, hypotonia and shaking. Had rhinorrhea and cough x 2 weeks. Decreased responsiveness after episodes. W/u (-).
Information has been received from a medical assistant concerning a 6 year old white male with no known allergies or medical history, who on 21-FEB-2001 was vaccinated in the left arm with a first dose of Varivax (lot # 635461/1246K). There was no illness at the time of vaccination. On 27-SEP-2006 the patient developed 50-100 pox all over, the patient had no fever. On 02-OCT-2006 the patient recovered. No additional information is expected.
I had not recovered from the first and especially the second doses of the Covid Vaccines.  Yet, I'd made some progress, prior to the 3rd Booster vaccine, in that I'd regained my ability to sleep and my appetite was much better. However, within about four days after the Covid Booster, I had a lot of trouble falling asleep and I have a very poor appetite again.  I've noticed a big increase in anxiety, feel like I'm "on a bucking bronco" and have trouble relaxing.  Brain fog and disorganization seems worse too. Constipation has increased.
This spontaneous report was received from a pharmacist referring to a 23 year old female patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 17-NOV-2017, the patient was administered a dose of ZOSTAVAX left arm, subcutaneous (dose, dose number and frequency  were unknown) with lot # N025386 and expiration date 08-DEC-2018, instead of VARIVAX (lot # and expiration date were unknown) by another unspecified pharmacist reconstituted with a sterile diluent (MERCK STERILE DILUENT) for prophylaxis. No adverse effects were reported.
allergy; Facial edema; mouth hurt; crying; This case was reported by a other health professional via call center representative and described the occurrence of allergy in a 30-month-old female patient who received DTPa (Infanrix) (batch number 5553K, expiry date 1st February 2021) for prophylaxis.   On 26th December 2018 10:51, the patient received the 4th dose of Infanrix (intramuscular) .5 ml. On 26th December 2018, less than a day after receiving Infanrix, the patient experienced allergy (serious criteria hospitalization), face edema (serious criteria hospitalization), oral pain (serious criteria hospitalization) and crying (serious criteria hospitalization). Infanrix was discontinued. On an unknown date, the outcome of the allergy, face edema, oral pain and crying were unknown.   It was unknown if the reporter considered the allergy, face edema, oral pain and crying to be related to Infanrix.  Additional information was provided as follows: The patient received Infanrix on the left thigh. Same day, the patient started with crying because the mouth hurt and patient had facial edema. The patient was seen at the emergency room on the same day at 11:52 pm and was admitted for 12 hours and then discharged the next day. The emergency room provided a diagnosis of allergy, unspecified. The patient's mother also reported to the physician's office that the patient would not be completing the vaccination series later on (5th dose or 2nd booster dose).
Pt recvd 1 dose of Engerix-B & w/in 5 hrs p/dose devel 101 degrees fever, vomiting & was dizzy; no tx was given; sx lasted 5 days;
myalgia in shoulders and neck; Provider stated she will not give 2nd dose; This case was reported by a physician and described the occurrence of myalgia in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included arthritis (patient has pre-existing arthritis).   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced myalgia and incomplete course of vaccination. On an unknown date, the outcome of the myalgia was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   The reporter considered the myalgia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient has pre-existing arthritis. The patient received Shingrix and experienced sever myalgia in shoulders and neck. The reporter believed this severe myalgia was a result of vaccination with Shingrix. The patient did go to emergency room for care. The patient's myalgia resolved after a few days. The provider stated she would not give 2nd dose, which led to incomplete course of vaccination. No additional information was provided. The reporter did not consent to follow up
After recieving vaccinations, pt stated she "feel like passing out".  She sat down and moments later had a syncope episode with returning to consiousness apprx 1-2 min later.  Oxygen was given, she was positioned supine with legs elevated, cool towels were applied and she was evaluated by the physician.
Awoke with extreme dizziness.  Over next few days, blacked out 3 times.  Vomited 3 times.  Remained in bed much of the time for a week.  Constant tinnitus (still present).  Current working diagnosis:  Vestibular Neuritis and Labyrinthitis.  Still have significant problem with balance (current date - 05/10/2021)
Throat tightening; dizziness; headache; shortness of breath; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 44-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Right on 24Mar2021 12:30 (Lot Number: EN6207) , (at the age of 44-year-old),as a single dose for covid-19 immunisation. Medical history included endometriosis from an unknown date and unknown if ongoing, seasonal allergy from an unknown date and unknown if ongoing and Known allergies: thimerosal, 4-Phenylenediamine base, methyldibromoglutaronitrile, disperse Orange 3, goldsodiumthiosulfate, textile dye mix from an unknown date and unknown if ongoing. Concomitant medication included fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication, start and stop date were not reported; ethinylestradiol, ferrous fumarate, norethisterone (KAITLIB FE) taken for an unspecified indication, start and stop date were not reported. The patient previously took thimerosal and experienced drug hypersensitivity, gold sodium thiosulfate and experienced drug hypersensitivity. If covid prior vaccination and If covid tested post vaccination: No and If other vaccine in four weeks: No. On 24Mar2021 at 12:45, (15 minutes after the shot), the patient experienced throat tightening, dizziness, headache and, shortness of breath. The patient did not receive treatment for the events. The outcome of the events was reported as unknown.   No follow-up attempts are possible. No further information is expected.
Severe swelling and redness at injection site.  Approximately 2 inch by 1 1/2 inch bright red area with surrounding pink area approximately 5 inches in diameter.
My daughter got her updated shots for school this year. Among the vaccines was a meningitis vaccine. After the vaccine, on the vaccine site, a large red saucer size rash appeared. This rash grew larger for a week then went away. It's been quite some time since the vaccine. Now my daughter has red bumps that appear all over her body, similar to the original red bumps, rash from the vaccine. These red bumps appear all over her body daily, then go away. Patient is on an antibiotic for strep. These red bumps went completely away with twenty four hours of starting antibiotics, then started reappearing, but only one or two now, while she's on the clindamycin, 150 mg, twice daily for ten days.
violent h/a (11-3), runny nose (10-30), ache all over (10-30) sore arm, unable to function due to chest pains (5NOV to 17NOV), sore throat, blocked ears, loss of appetite, unable to go to work, weakness, coughing;
Pt reported soreness of (R) upper arm. Mobility to raise arm to a reasonable height after 1 month, small bump at immunization site. Notified MD over phone. Pt has been sick w/ flu-like symptoms more than usual this year.
Started after 6 PM same day - swelling, dizzy, pressure on back of head, tingling sensation at back of skull:  Right headed swelling on face, extremities; swelling persisted on both ankles as of 2/24; pt rank it 8 of 10 still.  Used NSAIDS.
1/27 6:00pm- General not feeling well, stomach cramps 1/27 7:00pm-9:00pm- Skin painful, itchy, hives, all over reddness after soaking bath 1/27 9:00pm- Wheezing, cough, chest tightness Tongue swollen/pain, face swollen 1/28 7:00am- Tongue swollen/pain face swollen, hives/reddness and wheezing lasted into the morning and over next two weeks  Took Allegra and Claritin in the morning.  Went to allergists for steroids, took Prednisone.
her friend took the vaccine and reported sneezing; This is a spontaneous report from a contactable consumer (patient's friend). This consumer reported two reports. This is second of two reports. 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 dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter reported that her friend took the vaccine and reported sneezing on an unspecified date, the outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021304315 same reporter/drug, different patient/event
Vomiting and diarrhea with dehydration requiring hospitalization.  3/2/07 Received medical records from hospital which reveal patient experienced 2 days of vomiting & diarrhea.  Admitted 2/9-2/12/07.  Seen in Urgent Care & rehydrated night before admission but vomiting recurred & was admitted.  Noted to have otitis media on admit.  Received IV antibiotics in hospital & no antibiotics upon d/c to home. FINAL DX: gastroenteritis w/dehydration & acidosis.
pt vax on 7/28/98 & on 7/30/98 pt exp rash & reddened area round the inject site
pt recv vax & stopped breathing;pt was transported to hosp;pt was in ICU 2 days then transferred to regular care 5 days;11OCT97 w/apnea monitor;had 2 alarms @ home that day;alarm on 14OCT & 4 alarms on 16OCT97;dx SIDS w/reflux
Pt says she started getting red, round, flat, itchy marks on her skin that looks like bug bites.  If she scratches them they start to whelp.  They are on her forearm, left hand on the upper part of her thumb, forehead and ankle that are itchy.  There are a couple on the inner part of her thighs that are not itchy.  She uses alcohol wipes to help with itch.  On 5/18/21 pt went to her PCP.  She was told to report her symptoms to us.
My eyes have been occasionally twitching (lasts about 3 seconds) and this doesn't really happen. It occurs randomly throughout the day. I got the 2nd dose on the 4th but it's still happening  as I'm typing this report.
I got the shot and six days after I formed a rash on my left forearm. It was a big itchy bump at first I didn't treat that but then I noticed hives forming behind my ears so I took Benadryl and went to sleep. I woke up the next day with hives all over my body. I was at work so I put some Benadryl cream on me then I ended up leaving work early to see my primary and they prescribed me 5 days of promozone  and he hives kind of went away until day three of the treatment where I then noticed that the hives were again breaking through. Before being seen by a specialist I was taking Pepcid, Benadryl, and Zyrtec to treat the hives. My symptoms did subside but never went away. I then went to a allergist on 2/16/22 where they describe my hives as a dermographia. They prescribed me Xyzal for the hives . I take them once day and still take the Benadryl once or twice a week. My allergist described as a immune response and not allergy response. They also stated that they're not getting elevated blood counts when running other test on patients that described that same symptoms.
Marked swelling of R thigh (site of injection)with erythema and warmth.  Marked irritability and agitation.
Received Pfizer Covid vaccine at 11:30 am and after 5 min , she experienced dry and itchy throat. No change in voice, no wheezing , able to drink and swallow water without difficulty. Vital signs and O2 saturation /oximetry were normal.  After 30 min into observation, she c/o lightheartedness and both eyes were puffy. Vitals: BP 129/75, hr 91, O2 sat 99% at room air . Benadryl 50 mg IM given and client was taken to the Emergency room..
Rash; injection site was hard; injection site was swollen; The injection site was hard and swollen, and had raised redness about 2 inches wide; injection left her with a purple scar; injection left her with a purple scar; itching on the chest, neck and stomach; skin all over felt like pins and needles; joint pain in ankles, knees, and legs; This case was reported by a consumer via call center representative and described the occurrence of injection site induration in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site inflammation (1st dose received in August 2020).   On 17th November 2020, the patient received the 2nd dose of Shingrix. On 17th November 2020, less than an hour after receiving Shingrix, the patient experienced injection site induration, injection site swelling, injection site erythema, injection site scar, injection site discoloration, pruritus, pins and needles and joint pain. On an unknown date, the patient experienced rash. On an unknown date, the outcome of the injection site induration and injection site erythema were unknown and the outcome of the injection site swelling, pruritus, pins and needles, joint pain and rash were recovered/resolved and the outcome of the injection site scar and injection site discoloration were not recovered/not resolved.   It was unknown if the reporter considered the injection site induration, injection site swelling, injection site erythema, injection site scar, injection site discoloration, pruritus, pins and needles, joint pain and rash to be related to Shingrix.  Additional details were provided as follows: On 17th November 2020, within an hour, the patient experienced itching on the chest, neck and stomach, skin all over felt like pins and needles. The patient experienced joint pain in ankles, knees, and legs, the injection site was hard and swollen, and had raised redness about 2 inches.  The injection left the patient with a purple scar.  The reporter consented to follow up.
mom states pt got rash of rt upper arm & under arm & nausea & h/a;mom f/u w/MD felt it was a rxn to the vax w/DPH;
received vaccine on 29Oct2021 with an expiration date of 11Oct2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received vaccine on 29Oct2021 with an expiration date of 11Oct2021) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer COViD-19 (Second dose, LOT:EL3249) on 27-Jan-2021 and Pfizer COViD-19 (First dose).    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received vaccine on 29Oct2021 with an expiration date of 11Oct2021). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received vaccine on 29Oct2021 with an expiration date of 11Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter. No Treatment information was reported.
Patient stated that " she felt as if her skin was reddening and she was forming a rash". No visible signs of rash or reddening. Palpated skin, skin in tact no bumps. Patient stated that she "was feeling just a bit nervous but was ok".  Patient was release after 30 minutes of observation
She can hold a magnet to her arm and the magnet does not fall off the injection site/Magnet will not move unless she takes does not take it off.; Hurts when she takes magnet off the injection site/Pain stays there for about a half hour; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (She can hold a magnet to her arm and the magnet does not fall off the injection site/Magnet will not move unless she takes does not take it off.) and VACCINATION SITE PAIN (Hurts when she takes magnet off the injection site/Pain stays there for about a half hour) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included ANASTROZOLE (ANASTROL) for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (She can hold a magnet to her arm and the magnet does not fall off the injection site/Magnet will not move unless she takes does not take it off.) and VACCINATION SITE PAIN (Hurts when she takes magnet off the injection site/Pain stays there for about a half hour). At the time of the report, VACCINATION SITE REACTION (She can hold a magnet to her arm and the magnet does not fall off the injection site/Magnet will not move unless she takes does not take it off.) and VACCINATION SITE PAIN (Hurts when she takes magnet off the injection site/Pain stays there for about a half hour) outcome was unknown.      Treatment information was not provided.
Few hours after shot had pain in shoulder a day or 2 pain got worse and range of motion was limited. Few days later went to doctor and was put on an oral steroid. After about a week pain and range of motion was worse. Called doctor he put me on pain pills. Ordered an MRI. Pain and limit range of motion till this day.
Sore left injection site arm; Patient was fatigued; Expired vaccine provided to the patient as a booster dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left injection site arm), FATIGUE (Patient was fatigued) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine provided to the patient as a booster dose) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced VACCINATION SITE PAIN (Sore left injection site arm), FATIGUE (Patient was fatigued) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine provided to the patient as a booster dose). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine provided to the patient as a booster dose) had resolved. At the time of the report, VACCINATION SITE PAIN (Sore left injection site arm) and FATIGUE (Patient was fatigued) outcome was unknown.            No concomitant and treatment medication were reported.   This case was linked to MOD-2021-378237, MOD-2021-378227 (Patient Link).
p/recv vax pt devel fever greater than 100.8;blood in stools & sepsis;reporter stated "sepsis not related to vax'';
Mild Chills For about 15 Mins, achy muscles, sneezing, periodic running of nose, Scratchy throat, these are all mild symptoms and nothing i can not handle.  I was told if I experienced any symptoms to report them. I am feeling better this morning. The symptoms actually feel like a mild cold, I have had a flu shot on September 1 2020. and have had both pneumonia shots 4 years ago.
On 09/15/2000, the patient presented with chickenpox that consisted of greater than 50 lesions. Unspecified medical attention was sought. Additional information has been requested.
Fatigue, chills, sweats, decrease abduction right arm, pain in right arm, no rash or fever, no problems or complications following injection, no systemic symptoms improved at 2 weeks.