chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Area around the site had become quite red and swollen and extremely itchy.  Like a very large hive.  Slightly painful to the touch, but not extremely so.  The symptoms worsened at night to the point that I was mildly concerned about an allergic reaction.  The next morning the swelling seemed less and the area much less itchy, but increasing in size.  By 06/20/2015 at noon the red area had grown to nearly cover my upper arm.  Slightly warm to the touch.  I'm waiting till 06/22/2015 to see about going to my doctor about it.
Severe pain and soreness from injection site; Severe pain hrough  shoulder muscle and joint up to neck muscles.; Severe pain hrough  shoulder muscle and joint up to neck muscles.; dose 4 lot FJ9943/ dose 5 lot GJ3277 (both bivalent); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 at 13:00 as dose 5 (booster), single (Lot number: GJ3277) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "PAD" (unspecified if ongoing); "Covid" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Concomitant medication(s) included: XARELTO; CLOPIDOGREL; LISINOPRIL; ATORVASTATIN. Vaccination history included: Bnt162b2, bnt162b2 omi ba.4-5 (Dose: 4, product=Pfizer, lot number=FJ9943, vaccine location=left arm), for COVID-19 immunization; Bnt162b2 (Dose: 3, product=Pfizer, lot number=FF841, vaccine location=Left arm), for COVID-19 immunization; Bnt162b2 (Dose: 2, product=Pfizer, lot number=EN6201, vaccine location=left arm), for COVID-19 immunization; Bnt162b2 (Dose: 1, product=Pfizer, lot number=EL9265, vaccine location=left arm), for COVID-19 immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 24Oct2022, outcome "unknown", described as "dose 4 lot FJ9943/ dose 5 lot GJ3277 (both bivalent)"; VACCINATION SITE PAIN (non-serious) with onset 26Oct2022, outcome "not recovered", described as "Severe pain and soreness from injection site"; ARTHRALGIA (non-serious), NECK PAIN (non-serious) all with onset 26Oct2022, outcome "not recovered" and all described as "Severe pain hrough  shoulder muscle and joint up to neck muscles.". Therapeutic measures were not taken as a result of vaccination site pain, arthralgia, neck pain.
Presents with multiple complaints including body aches, chills, cough, and sore throat.
After I received the two vaccines back-to-back at the pharmacy, I had shortness of breath / sensation of moderate squeezing on my chest the following day. These symptoms persisted for four days (Nov 29 - Dec  2, 2021), and then went away. I have fully recovered and do not have any lingering symptoms at this time.
This spontaneous report as received from a Registered Nurse refers to patient of unknown age and gender. The patient's concurrent or historical conditions were not reported. On 11-OCT-2016, the patient received a dose of M-M-R II (Lot #L043702, expiry 03-NOV-2017) that was reconstituted with improperly stored sterile diluent (lot # L001533, expiry 24-OCT-2017) (dose, route not reported). The sterile diluent temperature excursion was reported as 95 F for a duration of 9.5 hours. No previous excursions were reported. No adverse effects were reported. No further information was provided. Additional information has been requested.
- 7-8 cm slightly erythematous asymmetric annular almost welt around small visible injection site on right upper arm c/w hypersensitivity reaction.
April 7, 2021, 9:00 am: Received 2nd shot with no issues. April 7, 2021, 11:00 am: Started having a sore arm. Nothing major. April 8, 2021, 1:15 am: Started a severe headache in my office. April 8, 2021, 1:30 am: Stood up in my office and immediately started chilling and shaking. April 8, 2021, 1:35 am: Went up stairs and wrapped up in a blanket and before I could lay down in bed, the room lost all dimensions and started ?waving? as though there were no walls to stop it. It looked like the room just kept going on forever in a completely open space (no walls or corners). April 8, 2021, 1:40 am: got under the covers with the blanket wrapped around me and the bed shook uncontrollable for about 30 minutes. I then slept for a few minutes at a time until about 5:30 am. April 8, 2021, 5:35 am: Got out of bed and still was very cold, but no chills. I put on my robe and wrapped in a blanket and went downstairs to me office.  April 8, 2021, 5:40 am: I took my sinus medicine hoping the headache would subside. April 8, 2021, 5:50 am: Typing this so I don?t forget how I felt the first nights after the shot. April 8, 2021, 6:15 am: Drank a cup of coffee. April 8, 2021, 6:45 am: Chills went away, and headache subdued some. Still have a headache though. April 8, 2021, 7:45 am: Went back to bed to rest. Slept on and off the rest of the day with fatigue, sore body, and headache. Let up around 8pm. April 9, 2021, 7:00 am: Got up feeling much better today.
Employee stated that her vaccinated arm was very sore for 2 weeks after vaccine was administered.
Developed a mild case of chickenpox. Started on 4/1/01 with a fever, then a rash on 4/6/01. All Scabbed over by 4/9/01. Also had strep throat and was treated with Zithromax and Zyrtec.
Narrative: PT PRESENTED TO ED WITH COMPLAINTS OF URINARY URGENCY AND FAMILY NOTED SIGNIFICANT PERSONALITY CHANGES OVER THE LAST FEW WEEKS. CT FOUND A LARGE FRONTAL LOBE MASS. PT WAS ADMITTED FOR FURTHER TESTING AND TESTED FOR COVID AS A PRECAUTIONARY MEASURE. HE TESTED POSITIVE, REMAINED ASYMPTOMATIC DURING HOSPITAL STAY, REQUIRED NO COVID TX OR 02 SUPPORT. PT WAS TREATED FOR NON-COVID  RELATED ISSUES AND WAS LATER DISCHARGED HOME.
Expired vaccine used/ Several patients vaccinated with expired vials; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/ Several patients vaccinated with expired vials) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/ Several patients vaccinated with expired vials). On 04-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/ Several patients vaccinated with expired vials) had resolved.            No concomitant medications information was reported. No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Dec-2021: non-significant follow up appended
Pt recvd 3 doses of Hep B vax in 1984, a dose of Recombivax in APR 1985 & a dose of Engerix-B & did not respond;
I am a community health nurse on the shelter-based service team with a health facility. I was onsite at a permanent housing program where the patient lives providing vaccines and primary care services. This patient had a COVID vaccination card with her. There were a total of three COVID vaccine doses documented. She received 2 Moderna doses early last year and a Pfizer booster in November 2021. She verbally confirmed with me that the most recent COVID vaccine was November 2021. I gave her her 2nd booster (Moderna) today.  After documenting the vaccine, I looked in medical records to obtain information about her other prior vaccinations, including the flu vaccine. I discovered that she had a 2nd booster provided in April 2022 that was not documented on the vaccine card, which the patient did not inform me about. So, she received an extra COVID booster dose (#3) today.   The patient did not have any adverse reactions. She waited 15minutes post vaccination and went back to her apartment with no complaints.
Pt came in 10/3/2018 to complain of redness, swelling and warmness around the injection site on the LEFT arm which the PNEUMOVAX was given; had fatigue, body chills, aches, pt took tylenol to relieve symptoms at night, states that she has started feeling better since; still has some redness; FLUZONE HIGH-DOSE given in Right arm, soreness in both arms.
The day following vax, pt presented with anterior fontanel full. No treatment indicated from results of CSF obtained. After 5 days, pt continued with fontanel full and CT of head was done with reading of negative study. Pt returned to office for recheck on 11/28/00 with full-fontanel resolved.
While in waiting room obtained a rash over arms and legs. Advised to wait 15 min later - after 5 min c/o tightness in chest. Advised to lay down. 5 min later no relieved. Was given diphenhydramine 1cc and continued to lay down. After 15 minutes, tightness relieved and rash started to subside. Went to Dr. who gave her prednisone.
Low Limb Edema.  Legs, ankles, Feet.  Went to Urgent Care, admitted to ER, they did blood work and head CT test. Was given Lasix, (diuretic) to reduce water weight in legs.  Have had to take 2 rounds of Lasix as swelling continues.  Currently not taking Lasix, and swelling seems to be increasing again.  Going in for heart echo (resting) Tuesday June 15 to see if myocardial or pericardial inflammation exists, since leg, ankle, foot swelling is a symptom of those.
Experienced stinging of needle and felt vaccine going in and radiating down the left arm. Sensation persist a few minutes. MD was notified. On 11/13/00, pt was called and she stated she was fine.
administered expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB37AA, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 5th August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was 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: 5-Aug-2022 Reporter's comment: A healthcare professional reported that they administered an expired dose of Bexsero to a patient by mistake. The reporter consented to follow up. Additional Supportive Information: Patient received a dose of Bexsero on 5th August 2022 which was expired on 31st July 2022, which led to expired vaccine used.
LUMP ON LEFT SIDE OF NECK; CHILLS; FATIGUE; HEADACHE; FEVER; SHAKING; FLU-LIKE SYMPTOMS; ACHYING JOINTS; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hashimoto's disease, seasonal allergies, and certain metal allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced shaking. On 10-APR-2021, the subject experienced flu-like symptoms. On 10-APR-2021, the subject experienced achying joints. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced fever. On 14-APR-2021, the subject experienced lump on left side of neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking, flu-like symptoms, achying joints, chills, fatigue, headache, and fever on 13-APR-2021, and had not recovered from lump on left side of neck. This report was non-serious.
Patient was pregnant at time of vaccination (1 week) and proceeded to have a miscarriage 3 weeks following vaccination.
pt had redness, swelling & pain from inj site (upper tricep) to lower  forearm;this occurred w/in 2 days p/vax;pt adm for 24hr of ATB & arm elevation w/good results;pt switched 6 day course to ATB;
Started to have mild fatigue in the morning 01/12/21, then started having  chills, headache, joint pain, malaise, muscle pain, nausea and pain at the injection site as the day progressed. Went home at around 3:50 PM
Patient mentioned that he was light-headed and felt like he was going to faint.  Also, he said that he felt nauseas.   Staff  helped patient move into exam room and laid him down on the bed.   Patient asked for water and it was brought to him.  Patient's vitals were low - BP : 70/39, Pulse : 68, Oxygen : 95.  Doctor came in and examined and spoke with patient and also oxygen was given; after a couple of minutes patient said he was feeling better.  Patient was vitaled again and this time - BP : 113/79 ; Pulse : 80.  Patient was observed for 30 minutes and then cleared.  Patient was instructed to follow-up with his PCP or emergency room if any more symptoms progress this evening.
Occipital lobe headache and blurred vision, inability to maintain alertness, bilateral upper extremity tingling and bilateral tingling of cheeks, slurred speech, forgetting to swallow (when my husband attempted to get me to eat dinner), inability to read or spell. This is the order in which my symptoms occurred, they lasted from ~7pm to 2am. Only residual symptom since this episode is migraines, which I have never experienced before.
Patient was given influenza vaccine 11/12/2011 returned to pharmacy 12/31/11 complaining of pain in the left shoulder since time of administration.
exacerbation of COPD ,  albuteral nebulizer , intubated , IV prednisone , IV antibiotics , aux . oxygen emergency room , ICU , three additional days in hospital full recovery after 4 days
Administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration) in a 74-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial did not undergo any temperature excursions. The vial initially stored in the refrigerator was unknown.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received contains non significant information, reporter address added.
Information has been received from a physician concerning his daughter, a female patient, with a penicillin allergy, who on 15-DEC-2006 was vaccinated with the first dose, 0.5ml, IM, of Gardasil. There was no concomitant medication. On approximately 15-JAN-2007 (" one month later") the physician's daughter experienced "numbness and pain in her right foot and leg." The physician reported that his daughter was examined by both a neurologist and a rheumatologist, and was not certain if she was "experiencing significant disability," but was waiting to see if the numbness and pain resolved. The physician reported there was "some improvement." Additional information has been requested. 01-Jan-2007 magnetic resonance imaging, Negative, 01-Jan-2007 serum C-reactive protein test, Negative, 01-Jan-2007 serum antinuclear antibodies test, Positive
This spontaneous report as received from a pharmacist refers to a 36 year old female patient. The concurrent condition and medical history was not reported. On 31-DEC-2014, the patient was vaccinated with RECOMBIVAX HB dose 1 (route unknown). The concomitant medication was not reported. The pharmacist reported that the patient was going to administer to second dose of RECOMBIVAX HB on 25-JUN-2015 (reported as today) which was outside of the recommended schedule. The pharmacist also reported that the patient was waiting to receive the second dose at the time of this call and she would administer it as soon as the call is over. The patient has not experienced any adverse effects. Additional information has been requested.
PAIN IN RIGHT ARM AT VACCINATION SITE. LIMITED RANGE OF MOTION-CANNOT LIFT ARM ABOVE SHOULDER-SORENESS LASTING GREATER THAN 3 WEEKS. TREATING WITH ALEVE (NAPROXEN) AROUND THE CLOCK.
Pt recvd 2 doses of Engerix-B & 2 & 1/2 hrs following dose 2 exp fatigue & h/a; still persisting;
Developed extremely itchy left eye near tear duct. Right eye slightly itchy. Very red and aggravated; burning, itching, irritated. Lasted ~36 hours,
Woke up am, large warm area just below injection site, red, hot swollen, hard.    Called my  Drs. office, went in for appt. she stated it was a reaction gave me prescription for prednisone.   Stated it was normal, no other symptoms.
Hives started on arms and then trunk eventually covering legs, feet, abdomen and back. Itchy. Some hives turned to red patches especially around wrist. Went to PMD: On XYZAL, 5 days of steroids and PEPCID. Started those on 10/23 from Clinic. Called Employee Health 10/30/17. Placed on MEDROL pack and asked to continue current meds. Seems hives are a tiny bit better. Patches on wrist are starting to fade but continue to be itchy. Had flu shots in past and no problems. No new soaps, foods, meds or lotions.
Syncopal episodes 4 days after vaccines administered occurred x3. First time in shower.  6/6/08 Reviewed PCP medical records & vax records.  Good health on day of vax, only hx of dysmennorhea.  Started bcp 2 days s/p vax & then 2 days later stared syncope.  6/13/08 Reviewed ER medical records of 5/27/08. FINAL DX: syncope, orthostatic Records reveal patient experienced dizziness & weakness while in the shower, felt things going black.  Had syncopal episodes x 3.  In ER, pale & weak.  Had started birth control 2 days prior.  Orthostatic in ER.  D/C to home to be f/u by PCP next day.
Per husband:  Numbness & tingling & body pain sent pt to doctor then hospital.  11/30/09 Medical records received. ED notes for 10/06 .  Final DX: Headache, dehydration C/O L arm, ear and finger numbness.  Tongue and lip numbness. Tingling. 25 weeks pregnant. Headache, intermittent bil abd cramps, nausea.  ICD9 Codes: 784.o, 276.82, V22.2
pt recv vax & devel an inj site rxn characterized by redness & soreness;this is 1 of 3 pt from this facility to devel an inj site rxn p/vax lot# 4978198
Persistently itchy rashes on left inner bicep, top of right ear, and a matchbook-sized patch on right side of waistline. Rash on bicep and ear have noticeable small blisters. Rashes on bicep and ear appeared first as small, defined points and then grew/spread. (I am not a medical professional. These symptoms sound similar to shingles symptoms. For what it's worth, I have not received the shingles vaccine, I had chicken pox as a child.)
I had two reactions. The first was the night of the inoculation during sleep. I woke up to a stabbing pain in my lower right abdomen. It came and went very quickly. It occurred twice. The second occurred the following day. It felt like I had a groin pull on my left side. The pain was intermittent.
No adverse event; Accidentally administered bivalent vaccine to a 2 year old patient from a vial with dark pink cap and yellow label, instead of the dark blue cap with grey border; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Accidentally administered bivalent vaccine to a 2 year old patient from a vial with dark pink cap and yellow label, instead of the dark blue cap with grey border) and NO ADVERSE EVENT (No adverse event) in a 2-year-old 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. 214K22A) for COVID-19 prophylaxis.     The patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 04-May-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .2 milliliter. On 04-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Accidentally administered bivalent vaccine to a 2 year old patient from a vial with dark pink cap and yellow label, instead of the dark blue cap with grey border). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Accidentally administered bivalent vaccine to a 2 year old patient from a vial with dark pink cap and yellow label, instead of the dark blue cap with grey border) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Accidentally administered bivalent vaccine to a 2 year old patient from a vial with dark pink cap and yellow label, instead of the dark blue cap with grey border).    No concomitant medications were provided. HCP did not know if any AEs where reported. No treatment medication was provided.
"Covid arm"; swollen injection site; vaccination site rash; itchy at the injection sit; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION ("Covid arm"), VACCINATION SITE SWELLING (swollen injection site), VACCINATION SITE RASH (vaccination site rash) and VACCINATION SITE PRURITUS (itchy at the injection sit) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced ADVERSE REACTION ("Covid arm"), VACCINATION SITE SWELLING (swollen injection site), VACCINATION SITE RASH (vaccination site rash) and VACCINATION SITE PRURITUS (itchy at the injection sit). On 20-Mar-2021, ADVERSE REACTION ("Covid arm"), VACCINATION SITE SWELLING (swollen injection site), VACCINATION SITE RASH (vaccination site rash) and VACCINATION SITE PRURITUS (itchy at the injection sit) outcome was unknown. Not Provided          Concomitant information was not provided. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-067598 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067598:
Patient does not speak the language well and her son was attempting to translate for her over the phone.  He said that her arm still has a lot of pain 5 days post vaccination.  I advised that she can ice the area as well as take OTC pain relief such as acetaminophen or ibuprofen.  He said she has done that and still has a lot of pain.  I advised that she should follow up with her physician if she continues to experience pain.