chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered pharmacist concerning a 67 year old female with no pertinent medical history and no known drug reactions/allergies who on 12-JUN-2008 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX vaccine (Oka/Merck) (LOT# 649404/1826U). There was no concomitant medication. On 07-JUl-2008 the patient returned to the pharmacy with a red streak 2.5 inches x 1 inch on the back of her right arm near the injection site. It was itchy but not raised. No treatment was required at this time. The patient's symptoms persisted. Unspecified medical attention was sought. Additional information has been requested.
Bilat rash upper thighs 24 hours after vaccines - fine raised rash in a patch.
Onset Bell's Palsy & contralateral leg weakness about 12 days after Varivax, HAV, & PCV7. Hospitalized: MRA negative, MRI negative. Rx: Acyclovir, Prednisone, Zantac, Lacrilube. Leg weakness resolved in less than 1 week.  11/06/07 Reviewed hospital medical records which reveal patient experienced left sided facial droop, unable to close left eye, left sided drooling, right leg weakness/dragging, poor appetite & fever. Admitted 9/2-9/9/2007 to PICU.  Neuro, ID & Optho consults done.  Had difficulty feeding due to oral motor uncoordination likely due to facial nerve palsy.  Tx w/steroids & antivirals.  LP done in ER was WNL. Improved & d/c to home on continued antiviral & steroids along w/eye care. FINAL DX: Bell's palsy, lower extremity weakness.
Headaches started at 5pm on 10/17/19, went to the ER on the evening of 10/18. Patient reports "worst headache in entire life", in bed for 5 days afterward, 10/22 is first day without headaches.
VACCINE WAS DRAWN UP THE DAY BEFORE AND WAS GIVEN AT THE 15 HOUR MARK.  PER MODERNA REPS, CLIENT IS TO BE CALLED TO SEE IF ANY REACTONS FROM VACCINE, CLEINT DENIES ANY REACTIONS TO THE VACCINE.
Got the shots and got shingles/suspected vaccination failure; Got light case, no lasting damage; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Family history included shingles (patient's wife had shingles 7 years ago) and nerve damage (patient's wife had left with permanent nerve damage).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the shots and got shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Got light case, no lasting damage). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient's wife via interactive digital media. The patient got the shingles shots and he got a light case of shingles with no lasting damage. The reporter stated that so it was just a personal choice whether to get shingles vaccine or not.  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available. The case had been linked to US2023AMR066976, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023AMR066976:Same reporter
An expired vaccine administered as a 2nd dose to a patient; 2nd dose Date of expired dose administered: 02Aug2021 and 1st dose on 21May2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (An expired vaccine administered as a 2nd dose to a patient) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose Date of expired dose administered: 02Aug2021 and 1st dose on 21May2021) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 039B21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included CETIRIZINE, IBUPROFEN, PANTOPRAZOLE, TAMSULOSIN, TESTOSTERONE, TRAMADOL and DEXTROAMPHETAMINE [DEXAMFETAMINE] for an unknown indication.   On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (An expired vaccine administered as a 2nd dose to a patient) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose Date of expired dose administered: 02Aug2021 and 1st dose on 21May2021). On 02-Aug-2021, EXPIRED PRODUCT ADMINISTERED (An expired vaccine administered as a 2nd dose to a patient) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose Date of expired dose administered: 02Aug2021 and 1st dose on 21May2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, since 13-NOV-2014 (also reported as since the first call when the reporter asked to evaluate improperly stored vaccines) those patients were possibly vaccinated with an improperly stored doses of ROTATEQ (therapy route defaulted to oral, dose, units, lot number were not reported). No adverse effects reported. Additional information has been requested.
STABBING PAIN IN STOMACH; NAUSEA; INJECTION SITE SORENESS; FEVER; LOSS OF 5-6 POUNDS; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, penicillin allergy, and keflex, tylenol and asprin allergy. The patient experienced difficulty in breathing when treated with hydrocodone bitartrate/paracetamol, and hives when treated with naproxen sodium, erythromycin, and swelling of the face when treated with magnesium sulfate.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On APR-2021, the subject experienced loss of 5-6 pounds. On 01-APR-2021, the subject experienced stabbing pain in stomach. On 01-APR-2021, the subject experienced nausea. On 01-APR-2021, the subject experienced injection site soreness. On 01-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site soreness, and fever on 03-APR-2021, had not recovered from nausea, and stabbing pain in stomach, and the outcome of loss of 5-6 pounds was not reported. This report was non-serious.
Patient vaccinated with Smallpox and Anthrax on  6 MAR 03 in left Arm, Previously vaccinated two wks earlier with Anthrax in right Arm.  On 15 march (9 days after vaccination) pt developed erythematous swelling in right neck associated with fever (temp 103.5).  Pt treated as outpatient with IM Rocephin and PO Augmentin without clinical improvement.  On 17 MAR, pt was admitted to local hospital. Diagnosis of deep neck cellulitis on right side with marked anterior and post cerival triangle lymphadenopathy.  Markedly robust take on left arm with lymphangitis in area confined to upper arm above elbow..
This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 55-year-old female patient who received SHINGRIX. On 18th May 2018, the patient received SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced tiredness, pruritus, enlargement of lymph nodes and pain. On an unknown date, the outcome of the tiredness, pruritus, enlargement of lymph nodes and pain were unknown. It was unknown if the reporter considered the tiredness, pruritus, enlargement of lymph nodes and pain to be related to SHINGRIX. Additional details were provided as follows: The consumer reported possible adverse reactions to SHINGRIX on online chat. The patient stated that she was not a health care professional and received SHINGRIX on Friday. The patient suspected that she was having a reactions like tired, achy, enlarged lymph node on my collar bone area and itchy.
not immunocompromised and received 100 mcg for booster dose; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (not immunocompromised and received 100 mcg for booster dose) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 06ZE21A, D11L21A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 100 mcg. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 100 mcg. On 23-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 100 mcg. On 23-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (not immunocompromised and received 100 mcg for booster dose). On 23-Aug-2021, ACCIDENTAL OVERDOSE (not immunocompromised and received 100 mcg for booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The reporter stated she and her husband were given the third shot, the booster, in late August. They both received a full dose of 100 mcg. It was the same as the first. The HCP stated that she was immunocompromised, but her husband was not.  No treatment information was provided.
I noticed right after receiving the vaccine that it stung at the injection site. I took it easy the rest of the day. The next day I went to the grocery store with my niece, and I remember feeling lightheaded. I noticed a red spot the size of a quarter around the injection site. It was also hot and sore. The heat, soreness, size, and color continued to increase. The size got up to softball size. I also had a low-grade fever. Yesterday I felt feverish and had extreme brain fog. I contacted my niece, who took me to the emergency room. My arm is still swollen and red and I now have lymph node involvement. When I got to the emergency room, my blood pressure was high. It came down before I left. At the emergency room, they assessed me and said that I was having a sensitive immune response and prescribed me 800mg ADVIL and told me to take BENADRYL as well. They sent me home and advised that if it got worse, to return. I am still experiencing pain and sensitivity in my arm, and I have at least one lymph node that is inflamed and others that are feeling a little sore as well.
Patient had vesicle develop on bilateral legs, thighs, forearms, and stomach. Severe itch. He was given Atarax and used OTC anti-itch lotion.
Patient said she was feeling hot, thirsty and dizzy. I asked her to remain seated and provided a cup of water. I told her to put her head between her knees. She was still dizzy and I asked if she wanted to lie down. She laid flat on her back and I propped her feet up. She requested more water, and I complied. After about 5 minutes, she said she felt well enough to sit up. She asked for more water, and I asked if she would prefer a pop (cold). She said yes. She drank the pop while sitting, and remained resting for another 15 minutes. She filled out our incident report, said she felt fine and went home. I spoke with her 2 and 1/2 hours later, and she was fine.
pt recv vax 8NOV95 & 14SEP96 pt exp mild case of breakthrough chickenpox;the reporter felt there was vaccine failure;
swollen lips; Body itchiness; This spontaneous case was reported by an other health care professional and describes the occurrence of LIP SWELLING (swollen lips) and PRURITUS (Body itchiness) in a 73-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031419) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 on 03-Jan-2022.    On 10-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 12-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced LIP SWELLING (swollen lips). In November 2023, the patient experienced PRURITUS (Body itchiness). At the time of the report, LIP SWELLING (swollen lips) was resolving and PRURITUS (Body itchiness) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medication was not reported. It was reported that the patient experienced allergy-like symptoms. It was unknown if the patient experienced any additional symptoms/events.  Treatment medication was not reported.
not move arm / muscles really hurt / thigh is very painful; flu like symptoms; thighs of both legs are burning and itching.; thighs of both legs are burning and itching.; Meralgia Paresthetica  / flare up; Meralgia Paresthetica  / flare up; thigh pain/Pain in arm/leg pain; It's hard to get to sleep but if I lay on side and put pressure on it that helps; Injection site left arm still hurting / pain radiates to thumb.; fever; chills; body aches/pain radiates to thumb/hurts to walk; could not really move her arm for about 3 days; This case was reported by a consumer and described the occurrence of injection site pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included meralgia paresthetica.   On 27th December 2020, the patient received Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site pain, fever, chills, general body pain, mobility decreased, muscle pain, influenza-like symptoms, itchy legs, burning leg, meralgia paresthetica, condition aggravated, pain in thigh and difficulty sleeping. On an unknown date, the outcome of the injection site pain, muscle pain and pain in thigh were not recovered/not resolved and the outcome of the fever, chills, general body pain, influenza-like symptoms, itchy legs, burning leg, meralgia paresthetica, condition aggravated and difficulty sleeping were unknown and the outcome of the mobility decreased was recovered/resolved.   It was unknown if the reporter considered the injection site pain, fever, chills, general body pain, mobility decreased, muscle pain, influenza-like symptoms, itchy legs, burning leg, meralgia paresthetica, condition aggravated, pain in thigh and difficulty sleeping to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had fever, chills, body aches, flu like symptoms and could not move arm for 2 days and still muscles really hurt deep inside and injection site left arm still hurting, pain radiates to thumb.  The patient previous condition meralgia peristatic was flaring and right upper outer thigh was very painful and it hurts to walk.  The patient try and sleep the outer thighs of both legs are burning and itching.  The patient had hard to get to sleep but if lay on side and put pressure on it that helps. Pain in arm and legs went away but it's flaring up again. The caller wants to know if condition could be why she experienced these reactions and if she should stay away from the SHINGRIX vaccine. The caller did not know if should get the second dose because she thinks the first dose is what caused the flare up in her condition, Meralgia Paresthetica. The reporter did not consent to follow up.  The caller did report to HCP and HCP was insisting patient still receive the 2nd dose vaccine.
On 08/2/04 started with area of redness on right thigh. Continued to enlarge to size of 5 inch diameter on 8/4 non tender. Monitor. Benadryl PO.
This RN reporting event for staff member at clinic. Patient received the Pfizer booster immunization on 8/30/22 at 1550. The lot number was FP7150. Vaccine was administered by medical assistant. Patient was walking with parents to the lobby to be observed for 15 min when patient fell to the ground. MA took vitals and on call provider was called to evaluate patient at 1555. Blood pressure was 97/74, O2 saturation was 100%, heart rate was 88. NP and a Pa-C evaluated the patient and assessed she was stable and helped them to sit up. Patient was sitting for 3 minutes before being helped up and walking to the lobby for their observation period. Patient provided fluid and observed for other reactions. Patient was feeling much better and left with family at the end of their observation time.
Pt came to a second dose Moderna clinic, was unaware of which vaccine he had received for his first dose. Staff did not check CIIS for record of first dose, unknown if pt had vaccine record card with him. One dose of Janssen was given on 4/1/21 and One dose of Moderna was given on 5/6/21.  No known adverse reactions as of this date.
Pfizer-BioNTech COVID-19 Vaccine: Black particulate found in 2 vials LOT FJ1620 EXP 02/22
Fever, severe headache, pain starting from injection site (left arm) traveling up arm, up back of neck then to right shoulder and down right arm to elbow, dizziness, nausea, weakness. 24 hours after injection, node under left armpit swelled to egg size with soreness and pain.
Received on 1-4-21 - Area became red right away. Became progressively worse & by day 6 she saw her PMD for cellulitis (L) arm. Completed a course of Augmentin.
This case was reported by a pharmacist via call center representative and described the occurrence of injected limb mobility decreased in a 59-year-old female patient who received SHINGRIX (batch number 2YN4S, expiry date 9th July 2021) for prophylaxis. On 10th April 2019, the patient received the 1st dose of SHINGRIX. On 10th April 2019, unknown after receiving SHINGRIX, the patient experienced vaccine administered at inappropriate site. In April 2019, the patient experienced injected limb mobility decreased. On an unknown date, the outcome of the injected limb mobility decreased and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that the patient received SHINGRIX vaccination yesterday that was administered very close to the shoulder bone, which led to vaccine administered at inappropriate site. The reporter described it as the bursa area. She reported that the patient told her the same day of reporting that she was unable to move her arm.
Patient received vaccine afternoon of 10/13/09, when she got up the next morning she noted it was itchy and had hives in the area, school nurse gave her some BENADRYL and it improved.
Arm hurts, throbbing up/down arm and over to neck area. No redness or swelling noted.
The next morning, she could hardly wake up and had no appetite. Saturday still no appetite but did drink and slept a lot, also extreme fatigue, headache. Neck and up the back of head was very painful. Had muscle pain throughout. Feels really good today.
Left thigh swollen, red, warm to touch, local cellulitis, prescription for Keflex.  Totally resolved on 07/23/2005.
the patient "passed out".; Information has been received from a nurse via a company representative referring to a 14-year-old healthy female patient. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.  On an unknown date (reported as a couple days ago), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, frequency, route, lot # and expiration date were not reported) for HPV prevention.         On an unknown date, the patient passed out. The patient responded after two "smelling salts" and was okay. The outcome of event was recovered. No lab Diagnostics/Studies was performed. Information about medical attention was not provided. The causality assessment was not provided.  Upon internal review, the patient passed out was determined to be medically significant.
When getting the shot a couple days later began having a fever, when the fever left noticed swelling in tounge and joints hurting. Went to quick care and was put on liquid steroids, but when finishing those the symptoms started to come back.
8DEC95 sore lt arm,hard area underarm also;flu like sx;9DEC95 sore lt arm,flu sx,lethargic,noticed red splotches on outer lt arm & on breast;instructed to take APAP or ASA & see MD
Approximately 4-6 days after my son was vaccinated with his first Hep B shot, he developed a pretty moderate sudden onset of stuttering, that lasted a few months and gradually slowed down to nearly being gone.
Received Typhoid and Anthrax Immunization and after 30 minutes had chest and throat tightness. Given 0.3 EPIPEN. Given BENADRYL 75po. EMS arrived, IV started, 125 solcereadrol, EKG done, transported to university hospital. Final Disposition: Transported to ED and alert, oriented, and speaking.
She had fever for multiple days, a rash started and lasted for about a month, she was hospitalized for unknown upper respiratory virus and was put on oxygen.
- Starting a day or two after booster shot, I woke up every day feeling hungover, despite not having had any alcohol. I had pounding headaches, general GI distress, disturbed sleep, and significant fatigue. - Those initial, more severe effects, faded somewhat after 1 week. But I still have ongoing GI issues which are significantly  impacting daily life. I'm still having disturbed sleep as well, though I'm unsure if that's simply a secondary effect caused by the GI issues. - The GI issues are: lots of heartburn/reflux (something I don't normally experience), bloating, morning diarrhea. I'll often wake up between 3-5am, unable to fall back asleep, with my stomach gurgling. - The sleep I do manage to get doesn't feel "restful" and most days I feel pretty fatigued as a result.  So far, I've been self treating with Pepcid (famotidine - 40mg/day) and Benedryl (diphenhydramine - 25-50mg/day). These have been somewhat helpful but don't seem to have really had a lasting effect. Once my morning pepcid wears off, I start to experience significant heartburn/reflux.
Patient was sick needed albuterol high fever developed abnormal gait walked with left leg to side regressed to crawling still has muscle weakness with no reason why.