chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 60-year-old, adult patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6-degree Celsius. On 10-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: right deltoid, batch number: 252230, expiry date: 31-May-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805509 was crossed linked to original cases 201804863 due to same reporter.
Extreme dizziness lasting almost 4 weeks; hand, arm tremor (greater on the left side) developed 2 weeks after second dose (also noticed by spouse). I am right handed
It had an emergency room visit, it was a suspected TIA based upon patient reported symptoms. Subsequent testing found no evidence.
Immediately after vaccination, pt displayed seizure-like activity lasting approximately 15 seconds, including unresponsiveness, posturing with arms tucked up to chest, jerking movements, and snorting/grunting respirations. Immediately following this event the patient was oriented to place, time, self, and situation, and neurologically intact. No apparent injury was sustained and patient denied any pain/distress. Pt was able to recall receiving vaccine. Pt stated this had never happened to her before, but that she does become light-headed with injections/blood draws. Vitals signs following this event were within normal limits except for hypotension of 81/59.
Large itchy red circular rash at the injection site appeared 10 days after vaccination.  Still apparant.
Patient wanted Janssen but received Pfzier. Miscommunication between scribe and nurse. Patient OK with receiving Pfzier dose and not angry.
Upset stomach at 8:00 PM on the first night, extreme fatique next AM (12/10/09) - fatique continued for 2 days, about 8:30 PM 12/10/2009 I started having tingles and cold sensations though my body on the opposite side as shot given.  Has continued and moved around the body.  Still have symptons at it is 12/14/2009.  Saw Doc.. auto-immune reaction more then likey doing blood work. Watch for GBS signs... still tired also and have no desire to eat.  Lost 8 lbs since wednesday.
Patient received the injection and 2 hours later his arm started to hurt and then his arm turned bright red and started swelling. This morning his redness is gone and the swelling has gone down a lot but still present. Arm is still very sore.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with ZOSTAVAX (Lot#, dose/frequency, route and duration were unspecified) in August 2009, "3 years ago". No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient experienced shingles in February 2011, "one and a half years ago". VZVIP packet not offered since the patient has recovered from the shingles. It was unspecified whether the patient had sought medical attention or not. Not treatment information was reported. Additional information has been requested.
Information was received on 07-JUN-2017 from a pharmacist regarding a 60 year old female patient. The patient's concurrent conditions and medical history were not reported. On 18-MAY-2017 the patient was vaccinated with ZOSTAVAX lot # M041511 expiration 08-JAN-2018, subcutaneous for prophylaxis which was reconstituted with sterile diluent (STERILE DILUENT) lot # M022416 expiration 17-DEC-2018. Concomitant therapies included duloxetine hydrochloride (CYMBALTA), acetaminophen, hydrocodone bitartrate(NORCO), gabapentin (NEURONTIN), alendronate sodium (FOSAMAX), levothyroxine sodium (LEVOTHYROXINE SODIUM) and alprazolam (ATARAX (ALPRAZOLAM)). The pharmacist reported the patient had an injection site reaction after receiving a dose of ZOSTAVAX reconstituted with sterile diluent (STERILE DILUENT). The pharmacist reported that the patient experienced itching at the injection site which began on an unspecified date a couple of days after the injection. The pharmacist reported that the patient developed a dime sized lump at the injection site on an unspecified date about a couple weeks after the injection. The pharmacist reported that the lump was not painful. The pharmacist reported that the patient appears to be recovering, but the lump is still present and somewhat itchy. The pharmacist also reported that the patient was prescribed azithromycin 500 mg to be taken once every Monday Wednesday and Friday. The pharmacist reported that the patient began taking the azithromycin on an unspecified date after the ZOSTAVAX was administered. The pharmacist reported that she is unaware of the indication for the azithromycin prescription. No additional information is available. Additional information has been requested.
On 11/13/2013 a 64 year old male was administered inactivated pneumococcal vaccine (single dose vial, Merck and Co (PNEUMOVAX 23), lot# J010332, exp: 01/14/2015) in the clinic. Later that night he noticed his whole shoulder was swollen, red, and painful. The next day he was seen in clinic and the nurse documented that his left arm from shoulder to antecubital region was red, hot to the touch, slightly swollen on the inner aspect of the arm, on and below the bicep. Patient denied fever, shortness of breath, and trouble breathing. Ice packs were applied in clinic and PCP wrote a prescription for prednisone. Patient was instructed to apply ice packs at home and take medication. Patient verbalized understanding and was told to return to clinic if symptoms get worse.
First shot: Mild sharp headaches of short duration. Difficulty breathing. Severe Tinnitus.  Second shot: Severe Tinnitus.
Convulsions  Slurred speech Hallucinations  Twitching  4pm
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 17-JUL-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 0.5 ml (lot # K011492, expiration date 22-JUN-2016. No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion three times. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 24, 34 and R. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 176, 48 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
24 yo with history of atrial tachycardia and anxiety, noncompliant with medication (diltiazem,  klonopin) presented with tachycardia, chest pain,  nausea, dizziness 1 min after vaccine administration. Vitals improved over time but pt had sustained chest pain and dizziness throughout response.
had rash & temp for 5 days about 10 days to 2wks p/vax;then had swollen feet, legs, hand & arms w/lumps;remains stiff & very sore;problems w/sleeping d/t pain & stiffness;
inadvertently exposed to 55F / administered to patients.; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAV (Havrix) for prophylaxis, hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis, hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis, dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix, Kinrix Pre-Filled Syringe Device, Havrix, Havrix Pre-Filled Syringe Device, Engerix B, Engerix B Pre-Filled Syringe Device, Boostrix, Boostrix Pre-Filled Syringe Device, Infanrix, Infanrix Pre-Filled Syringe Device, Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix, Kinrix Pre-Filled Syringe Device, Havrix, Havrix Pre-Filled Syringe Device, Engerix B, Engerix B Pre-Filled Syringe Device, Boostrix, Boostrix Pre-Filled Syringe Device, Infanrix, Infanrix Pre-Filled Syringe Device, Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 details were provided as follows: The age at vaccination was not applicable to this report The nurse stated that Kinrix, Havrix, Engerix-B, Boostrix, Pediarix, and Infanrix was inadvertently exposed to 55 degree Fahrenhiet for as long as two weeks which led to incorrect storage of drug. Worst case scenario, some of the vaccines were administered to patients. No further details available at the time of this call, but nurse granted permission for safety to follow up via mail. The reporter consented to follow up.
Female patient 17 years of age received the vaccine; A spontaneous report  was received from a pharmacist concerning a 17-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced female patient 17 years of age received the vaccine.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 31 Dec 2020, approximately 0 hours prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 31 Dec 2020, a 17 year old female patient was administered the vaccine. No additional information was provided. No treatment information was provided.  Action taken with mRNA-1273 in response to the event(s) was not reported.  The event, female patient 17 years of age received the vaccine, was considered resolved on 31 Dec 2020.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of product administered to patient of inappropriate age.
Got the shingle shot 2 times, still got shingles/Suspected vaccination failure; shingles/Got the shingle shot 2 times, still got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 29-July-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the shingles shot 2 times and still got the shingles. The patient stated that they would not give the patient no more shots told the patient to talk to the his/her physician. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
12/13/2022 tested positive for COVID-19. I had an early on sore throat and that was about it and it just felt like it was a normal bad cold and I started getting better real quick after that. It feels like a lingering minor cold. I have tested positive for 2 weeks now and I did 5 days of PAXLOVID. I only felt terrible for a couple of days like I had a cold and it's been hanging on like a super minor cold and that is what I feel like now.
Lightheaded, HA, vision changes, shaky, chest pain, facial flushing, cleared by EMS-
pt waiting 15 minutes observation period no issues about 45 minutes after injection pt had a slight rash then next morning had a full body rash
Information has been received from a physician concerning a 17 year old female who in May, 1999 was vaccinated IM with the first dose of Hep B vaccine. Approximately one week post vax, the pt experienced a rash. In June, 1999 the pt was vaccinated IM with the second dose of Hep B vaccine. Approximately 10 days post vax, the pt experienced a more severe rash characterized by swelling and large vesicles or hives starting on the hands and then becoming generalized. Hives are covering 65% of her body with intense itching." The pt was seen by a dermatologist on 8/5/99 and treated with prednisone, loratadine and ciprofloxacin. The pt's father called the dermatologist and reported that his daughter "is not much better." The pt has since returned to school out of state. No further information is available.
7/2/15 Pain in rt arm, redness 1 hr after injection which increased daily-swelling leg 2nd day. 7/3/15 Pt called clinic advised ice & elevation with ibuprofen for pain 500 mg tid. 7/4-7/7 pt c/o increased pain edema & swelling. 7/7/15 pt came in for evaluation and treatment. Photos taken prednisone 4mg dose pack given.
skin warm to touch, did not check temp. sweating, freezing, shivering, headache, muscle ache, nausea lasted approx 5 hours
This case was reported by a pharmacist and described the occurrence of not responding to therapy in a male subject of unspecified age who was vaccinated with HAVRIX (GlaxoSmithKline). On 9 September 2011 and 9 March 2012 the subject received 1st dose and 2nd dose of HAVRIX (unknown). On 20 April 2012, 42 days after vaccination with 2nd dose of HAVRIX, 7 months after vaccination with the 1st dose of HAVRIX, the subject experienced not responding to therapy. The subject had a titer performed on 20 April 2012 and showed non reactive. The healthcare professional reported several subjects did not respond to Hepatitis A vaccine; seven with HAVRIX and three with TWINRIX. For the other subjects please see OCEANS cases A0994238A - A0994246A.
Information has been received from a nurse concerning a 13 year old female student who on 30-JAN-2007 was vaccinated IM in the left arm with the first dose of GARDASIL (Lot # 655617/1447F).  On 06-Apr-2007, the patient was vaccinated IM in the left arm with the second dose of GARDASIL (Lot # 656051/0244U) and on 18-MAR-2008, the patient was vaccinated IM in the left arm with the third dose of GARDASIL (Lot # 659964/1978U).  On 30-JAN-2007 the patient passed out in the hallway after the first dose of the vaccine and was monitored until feeling better then allowed to leave.  After the second dose the patient felt a little dizzy and sat in the office for 20 minutes.  The patient was fine after the third dose and sat in the office for 20 minutes.  Patient outcome was recovered.  Additional information has been requested.
She slept all night the night after her shot. Then every 15-20 minutes the second night she was screaming. She had brief tremors.  The next day at daycare she slept all the time, no twitching or tremors.  She's not eating as much but is alert and active today.
Wife not fully vaccinated was COVID (+) 10/19 Patient was tested 10/22 results negative; developed headache Sunday night and was tested on Monday 10/25 with (+) results.  Patient is a chiropractor who was fully vaccinated and will quarantine for 10 days before returning to his practice.
Client come to clinic requesting first COVID vaccine and requested Moderna. I looked over online pre-vaccine checklist, asked client if any allergies, none noted. I went and pulled the Moderna Monovalent Vaccine that was placed in fridge to thaw on 3-31-23, gave 0.5ml of Monovalent Moderna went to put in local records and not showing up looked in all meds including expired and showed to have expired on 4-1-23.  have contacted client via phone to let her know about the vaccine and it showed expired on 04/01/2023 and that I have contacted Moderna and am waiting for a definite answer and that I will call her back once I get the answer form Moderna about the expiration date. Client didn't voice any concerns or have any questions, but I did reinstate before hanging up with client that I will call once I receive information back.   04/06/2023--Followed up with client this AM via phone checked in with client to see if she was doing OK and if she had any symptoms from the injection or any redness at injection site, client denied any symptoms. I let her know I did receive an email back from Moderna and told her that the dose that was given maintained activity necessary to protect against COVID at the time of administration. Client understood and thanked me for calling her back with the update.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 10-DEC-2010, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2016, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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.
Arm swelled to my elbow and into my chest. Very sore and hot. Took three days to ease up.
Client received HPV 2 dose.  No history of syncope with vaccines or any medical treatments.  Pt received 3 vaccines last year 06/03/2022, HPV, Tdap and MCV4 without syncope episode.  Father and client escorted to cashier window.  Patient became dizzy and patient assisted to a chair.  Cold compresses applied to neck, legs elevated, and patient monitored.  Pt alert and oriented after a minute, no c/o dizziness, pt monitored for 30 minutes after episode.  Client given water and a snack.  Client left with father.
Initial report was received from a health care professional on 08 Jan 2010: This patient had a history of chronic pain, vasovagal syncope, back surgery in 2004 and hip replacement. Patient's concurrent conditions included osteoarthritis, degenerative joint disease, irritable bowel syndrome, hypertension and chronic constipation. The patient received the S-OIV FLUVIRIN on 07 Jan 2010. On 08 Jan 2010 patient experienced vomiting and diarrhea. It was reported that patient walked to the bathroom but was unable to walk back to her bed, before this incidence patient was able to ambulate. Patient had not fever. The outcome of the events was not reported.
1 day after vaccination I experienced muscle pain, weakness, and chills. Symptoms lasted for roughly 1 day.
He got his vaccine, and within 1 hour his oxygen levels dropped super low and have continued to do so since then, and have been in the low 80's, high 70's especially if he walks too much or does too much.  He continues to drop down on exertion, and has to use his rescue inhaler or uses his oxygen to bring it up.  His lowest oxygen level was 72 on the day of the vaccine 12/16/22.  He did call his doctor and went in to see him, and he informed him that he didn't hear of anybody having this problem.  He has run into a few people that have had the same problems after this vaccine.  His doctor said to see how it goes and hopefully it would improve, which it hardly has at all.  It has not gone back down to the low 70s.  He cannot go get firewood and when he does he is short of breath.  He used to chop wood and do things, and now he cannot.  If he does his oxygen drops down to the low 80s.  This all started after the vaccine and now is hardly able to do anything.   When he was at the doctors off his level was 97, and then dropped down to 72 that day.    He has emphysema and got the vaccine due to have pneumonia in his lower lobe, but was hesitant about doing it, and now he's having all these issues.  He was able to live life a little better before the vaccine and now is unable to do things.
TASTE DISTURBANCE; SMELL DISTURBANCE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203a21a,expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced taste disturbance. On 08-APR-2021, the subject experienced smell disturbance. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from taste disturbance, and smell disturbance on 08-APR-2021. This report was non-serious.
Patient received a 3rd dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st and 2nd dose in 2019).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt date: 15-Feb-2023. Reporter's Comment: In 2023, patient received 3rd dose of Shingrix.  The pharmacist declined to provide patients date of birth but stated the patient was 81 years old. The pharmacist did not have vaccination dates or further details regarding the vaccine. The reporter did not consent to follow-up. Additional Supportive Information: Patient received a 3rd dose of Shingrix, which led to extra dose administered.
1) 22 hours after injection, got flu-like symptoms (chills, hot flushes, muscle aches, general weakness and lack of appetite) for about 10 hours.  Injection site was also sore. 2) 40 hours after injection, started to get shingles symptoms in LEFT arm (injection was in right arm). Pain, mostly in biceps muscle, but also in crook of elbow where about 4 red spots appeared.  Pain moves around, but is not affected by massage.  Arm is very sensitive to cold -- I feel much better when it is covered by several layers or soaking in a hot bath. Symptoms have continued to time of writing (6 days after injection).  Should on left side near the neck has also become sore in the last day or two.