chrisvoncsefalvay/vaers-outcomes huggingface dataset:
46 days after receiving the second shot Shingles outbreak/ Suspected vaccination failure; shingles outbreak; pain; symptoms; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 85-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and mepolizumab (Nucala) solution for injection in pre-filled pen for asthma.   The patient's past medical history included herpes zoster (it was resolved). Previously administered products included Zostavax. Concurrent medical conditions included asthma.   On an unknown date, the patient received the 1st dose of Shingrix, the 2nd dose of Shingrix and Nucala at an unknown dose and frequency. On an unknown date, unknown after receiving Shingrix and Shingrix and not applicable after starting Nucala, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and adverse event. The patient was treated with valaciclovir hydrochloride (Valacyclovir). The action taken with Nucala was unknown. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, pain and adverse event were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and adverse event to be related to Shingrix and Shingrix. It was unknown if the reporter considered the shingles, pain and adverse event to be related to Nucala.  Additional information was provided as follows: The case was reported by patient himself. The age at vaccination was not reported. The patient had the Shingrix vaccine for shingles, both in the series also before starting on Nucala. He started Nucala about 18 months before time of reporting, 46 days after receiving the second shot of Nucala he had a second Shingles outbreak, which was treated with a prescription antiviral, valcyclovir. Pain and symptoms resolved within one week. The reporter consented to follow up. This case was considered as suspected vaccination failure as details regarding time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Pt claims approx 1 wk p/vax devel lt sided facial paralysis; pt seen by MD was dx w/bells palsy cont to have some residual paralysis;
This spontaneous report was received from a medical assistant refers to an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unspecified date, the patient was vaccinated with an improperly stored doses of GARDASIL 9 (lot# L040054 with expiration date 26-DEC-2017) (dosing regimen was unknown). No adverse effects have been reported. No product quality complaint was filed. Additional information has been requested.
Information has been received from a 64 year old female with no known allergies who in 2007, about a year ago, was vaccinated with Zostavax (Oka/Merck) 0.65 mL.  Concomitant therapy included an unspecified thyroid medication.  The patient reported that she had not developed immunity to shingles.  In addition the consumer reported that the vaccine would have been administered sub q instead of IM, but she is not sure.  The patient sought unspecified medical attention.  There was no product quality complaint.  Additional information has been requested.
This spontaneous report was received from a pharmacist student referring to a patient of unknown age and gender. The pharmacist student noted that the patient was vaccinated with an expired dose of M-M-R II (lot # 1404AA, expiration date 08-SEP-2013), subcutaneous on 04-OCT-2013. No adverse effect was noted. Additional information has been requested.
This spontaneous report as received from a nurse refers to a 14 years old patient (unknown gender). No concurrent condition, medical history or allergy/drug reactions were reported. On 26-MAY-2015, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, dose number 1, lot # K006960, exp. date: 19-FEB-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Patient received the vaccine, shortly after receiving the vaccine (1-2 minutes), the patient begin to feel dizzy and started hearing a ringing sound in her ears.
Despite not having any abnormal reactions immediately following the vaccine (except for pain at site of injection, muscle aches, chills - which went away after 3 days), a week after the vaccine, I noticed that my left arm was hard around the injection, and a bit itchy. I massaged it a bit, and it started hurting - that night, I woke up from the pain, and had to take ibuprofen to sleep (probably 4/10). The area of also warm, red, and swollen, so I iced it, which made the pain better. This went on all of Friday as well - I took some Benadryl, and that seemed to make it better (or it might have just made me sleepy enough that I didn't notice, I'm not sure). I measured the area of redness at 8.5cm at longest diameter. Saturday, the pain was mostly gone, but the skin remained red and itchy, although the redness was a bit faded. Some small bumps appeared, however. There was also a second area of redness and pruritus measuring 4.5cm that was located a bit more upwards on the arm than the original area of redness. Sunday, the redness in both areas continued to fade, but the bumps were noticeable and more itchy than before. The hardness seems to have resolved almost completely, although the area is still a bit sore when massaged.
This spontaneous report as received from a physician via a field representative refers to a female patient of unknown age. No demographics were provided for the patients, other than the gender. The pertinent medical history and drug reactions/allergies were unspecified by the reporter. On an unknown date, patient was vaccinated with PNEUMOVAX23 (dose, route and lot number not reported). Concomitant medication at the time of event was unspecified by reporter. On an unknown date, patient experienced cellulitis at the injection site, after receiving PNEUMOVAX23. The patient was treated with antibiotics (unspecified name, dose/frequency and manufacturer). The event cellulitis was recovered on an unspecified date. The patient sought medical attention, and made an office visit on an unspecified date. No product quality complaint (PQC) was reported. The causality was snot reported. This is one of the two cases reported by the same reporter. Additional information has been requested.
Patient presented to the ED and was subsequently hospitalized for unstable angina within 6 weeks of receiving covid vaccination. She died on 2/8/2022.
"I also received a flu shot and the pain has not gone away.  Although I thought it was just me & old age, it turns out others have the same symptoms.  Someone mentioned info about an incident report."  "I wish I would've taken a picture but had a bruise was on my arm for 2 weeks."
The doctor gave her all the shots at once after I specifically asked him not to because my son and I have had adverse reactions, he went and did them all anyways in "combined vaccinations" and she ended up in the ER the next day with a rash(chicken pox, measles, who knows??) A fever of over 103 and we stayed most of the day. She was given steroids, rested, sent home. The rash took weeks to go away, she wasn't herself for months, it made me genuinely afraid of getting her next shots.
head splitting; couldn't move; freezing with chills; sick/ she felt sicker and sicker by the minute; tiredness/She left work and came home and went straight to bed; nausea all the time/wanting to vomit; muscle pain; feeling unwell; she has the flu, the regular flu; achy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 86 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 01Apr2021 12:15 (Lot number: ER8732) at the age of 86 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: ILLNESS (non-serious) with onset 07Apr2021, outcome "not recovered", described as "sick/ she felt sicker and sicker by the minute"; FATIGUE (non-serious) with onset 07Apr2021, outcome "not recovered", described as "tiredness/She left work and came home and went straight to bed"; HEADACHE (non-serious) with onset 08Apr2021, outcome "not recovered", described as "head splitting"; MOVEMENT DISORDER (non-serious) with onset 08Apr2021, outcome "not recovered", described as "couldn't move"; CHILLS (non-serious) with onset 08Apr2021, outcome "not recovered", described as "freezing with chills"; NAUSEA (non-serious) with onset Apr2021, outcome "not recovered", described as "nausea all the time/wanting to vomit"; MYALGIA (non-serious) with onset Apr2021, outcome "unknown", described as "muscle pain"; MALAISE (non-serious) with onset Apr2021, outcome "unknown", described as "feeling unwell"; INFLUENZA (non-serious) with onset Apr2021, outcome "not recovered", described as "she has the flu, the regular flu"; PAIN (non-serious) with onset Apr2021, outcome "not recovered", described as "achy".  Additioinal information: It was reported that after about a week of taking Covid 19 vaccine, on 07Apr2021 the patient experienced feeling sick. The next day, the patient woke up with splitting head ache and couldn't move, She was freezing with chills and she had nausea. The patient reported that she just has old age and she takes her regular medications in the morning and in the night. She doesn't think they are relevant. She reports it feels like she has the regular flu and was achy. The patient has a feeling like she is wanting to vomit and has nausea all the time. The patient clarified that had no episodes of vomiting.  No follow-up attempts are possible. No further information is expected.
Headache, Body Aches, Shakiness, Fever - Symptoms started same day - 4 days
Breakthrough COVID-19 case: I went to a convention and was notified by email that I should test for COVID. I had intermittent chills. The next day I went to get a PCR test I tested for COVID-19 and it came back positive. On 04/28/2022 I had a Monoclonal treatment. On 05/06/2022 I had another PCR and it still came back positive. I did not notice until after the quarantine period that I didn't have any taste or smell. I developed an allergy like symptom and those symptoms include a stuffy nose, heavy mucus, coughing. Mucus does not have color and is sometimes wet and sometimes a fur ball. I went to the emergency walk-in clinic about 2.5 weeks ago. They did a chest X-ray and it came back clear. They prescribed some cough medicine and did a nasal influenza test which came back negative. I have been experiencing a lot of fatigue. I don't know if it is because I can't sleep at night or if it is long COVID. I went back to the clinic to see my PCP. They did another X-ray and it still sowed my lungs were clear. They told me to take another dose of cough medicine, an allergy medication and a high dose steroid. I refused the steroid. It's been about a week since I went to see my PCP and the allergy like symptoms have not gone away. I'm still feeling fatigue. I still have no smell and no taste.
Pt returned to pharmacy on 07/05 complaining arm still hurts and said it was swollen shortly after the injection.
I was suffering from extreme body ache, it was awful. The lymph nodes under my left arm swelled into the size of a baseball. I was unable to lift or use my left arm. The lymph nodes in my neck became swollen and created difficulty swallowing. The pain in my neck was aching and tightness. I was unable to work for three days.  I was prescribed steroids from my doctor and that helped a bit. Two weeks after I have been suffering from hot flashes and fever. I was given an EKG on November 17, 2021, the results came back as abnormal. I now have an upcoming appointment with a cardiologist.
This is a spontaneous report from a contactable nurse. A 26 years old female patient started to receive PREVNAR 13 (lot #657035, Expiration date Oct2015) intramuscularly on 04NOV2013. Relevant medical history included high blood pressure, and hyperlipidemia; both since an unknown date. Relevant concomitant medications included LIVALO at a dose of 2mg daily for hyperlipidemia and LISINOPRIL/HYDROCHLOROTHIAZIDE tablet orally at 20/25 mg daily (two tablets of 10/12.5 mg each) for high blood pressure. It was reported that on 04NOV2013, the patient experienced a local reaction in left deltoid when the shot was administered and later on it became the systemic reaction on the same day. Relevant laboratory data was unknown. Therapeutic measures taken in response to the event included ice at an unknown dose and frequency and CELESTONE intramuscularly at a dose of 6 mg (unknown frequency). Clinical outcome of the event was unknown at the time of report. The nurse confirmed that the event was due to PREVNAR 13.   Follow-up (26DEC2013): Follow-up attempts completed. No further information expected.
Pt arm is swollen with red patches. Pt was advised to take BENADRYL and if redness travels further down the arm or BENADRYL does not work to call their doctor.
pt came to door & opened it;pt looked very pale, grabbed the door & sate down on floor;had pt lay down;pt stated was dizzy;pt stated read back of Td info sheet & panicked;pt sat a few min then color was good;
Headache FATIGUE, PAIN/SWLLING INJ SITE Narrative:
Pt endorse symptoms of fatigue, body aches, headaches, fever, and localized pain and swelling at the site of injection on day of injection 5/3/22 and 5/4/22. On 5/5/22 he developed sore throat and lymphadenopathy of the right axillary chain.
From information received via the telephone at Aventis Pasteur Inc. on 03/08/02, it was reported that 2 children,a 15 month old and an 18 month old developed large, local reddened areas at injection site after being vaccinated with Tripedia. the reddened areas were hot and warm to the touch. Both patients were treated symptomatically . One of the patients was treated with Keflex for possible celllulistis; however the patient's identity was not specified. Reportedly both patients improved. This case is linked  to U200200172.
After my first dose, I started feeling left head pressure kind of dull pain on the same day. Then it gradually increased and I met my primary care provider with series of visits. Have taken ibuprofen and other pain relievers for days. But there were no improvements. On Apr 17 I went to the emergency room for treating the unknown problems. They have taken MRI, CT everything came negative. After a month another symptom kicked in. Which caused my ear popping and clicking and buzzing sounds. Again we visited our primary care doctor and ENt, dentist. ENT was suspected I may have inflammation and have TMJ. Then they asked us to take MRi with our own pocket money. mRI RESULT again came negative. Currently I am having still ear popping and clicking buzzing sounds. I don't know what is going on my health after the vaccine. We are still following up with ENT doctor.
Pt was in the waiting room waiting 15 mins post vaccine. He was sitting with father and felt dizzy and put his head down. Father said pt has fainted in past and was expecting this reaction. Pt was dizzy for less than a minute and we gave some orange juice and he felt better.
Severe headache; worst of my life; 8 on a 10 scale. Frontal headache with nausea.
Only little tenderness with second shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Only little tenderness with second shot) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (Only little tenderness with second shot). At the time of the report, VACCINATION SITE PAIN (Only little tenderness with second shot) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment medication was not provided.  The patient was concerned as she didn't had any side effects and wants to know if the vaccine was working in her body or not.   Reporter did not allow further contact
Patient came into clinic for PPD check-up.  Menactra and PPV 23 were administered on 3/31/08.  Both vaccines were administered to left upper arm.  Patient upper arm is swollen, red, warm to touch.
Patient received Tdap on 4-5-18 in left deltoid. On 4-6-18 pt. had swelling, warm to touch, and pain in left arm. She had diarrhea, stomach cramping, and fever on 4-7-18. Patient was seen in clinic today, 4-9-18 and to start BENADRYL and ice the left arm.
Headache, Myalgia, Fever, numbness to left foot for 30 minutes durations after administration Narrative:
Patient is employee at the store where Vaccine was given, came by clinic to say she has had mild episodes of chest pain since Covid Vaccine #1 given on 10/28/21 and second dose 11/18/21 . Happens occasionally and is mild. Reported symptoms to the clinic on 11/19/2021 7:45 pm
his right elbow and the muscle of his right forearm is swollen; right arm is sore today/right elbow sore to the touch; Right arm cramp; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Right arm cramp), SWELLING (his right elbow and the muscle of his right forearm is swollen) and VACCINATION SITE PAIN (right arm is sore today/right elbow sore to the touch) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Oct-2021, the patient experienced MUSCLE SPASMS (Right arm cramp). On 29-Oct-2021, the patient experienced SWELLING (his right elbow and the muscle of his right forearm is swollen). 29-Oct-2021, the patient experienced VACCINATION SITE PAIN (right arm is sore today/right elbow sore to the touch). At the time of the report, MUSCLE SPASMS (Right arm cramp), SWELLING (his right elbow and the muscle of his right forearm is swollen) and VACCINATION SITE PAIN (right arm is sore today/right elbow sore to the touch) outcome was unknown.            Concomitant and Treatment medications were not provided.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-368757, MOD-2021-368774 (Patient Link).
Employee states that she received vaccine at 4PM.  That evening around 7PM, she was in a drug store.  Her throat started closing, chest started filling up.  Face got hot.  Vaccinated arm, head and eyes were hurting.  Pharmacist told her to take Benadryl and she did.
This spontaneous report was received from a Doctor of Pharmacy concerning a 63 years old male patient with no pertinent medical history or drug reactions/allergies who on 13-JUL-2012 was vaccinated with a dose of ZOSTAVAX (dose and route not provided) (lot # 672607/1716AA, expiration date on 02-FEB-2013). On 15-JUL-2012, the patient developed a large "welp" at the injection site after vaccination with ZOSTAVAX. At the time of the report, the patient had not recovered from the event. The patient contacted the pharmacist. The relatedness for large whelp at the injection site was unknown for ZOSTAVAX. Additional information has been requested.
pt vax hepta B. w/i 24 hrs pt ex fatigue, weakness, h/a, malaise. w/i 24 -48 hrs pt ex fleeting nausea in morning, gen aching, abdo pain, cramping, mild shoulder and neck pain, and diminished appetite. stools were more frequent. see worm...
I administer 0.5 ml of vaccine to her around 03:20 pm on 09/24/2020 in pharmacy. She was with her father and mother walked to front of pharmacy when I was told that she collapsed. I rushed to front of pharmacy with Epipen 0.15 mg, but it was not administered, both me and father bring her back to consultation room. In the mean time Mom has called EMS and they arrived. He vitals were monitored by EMS and were normal. Parents refused to go to ER or seek any other medical advise. I called her mother again at 05:02 pm today and asked how is patient doing. I was told she is fine and doing her homework.
Major developmental regressions in speech, executive functioning, coordination, sensory issues, cognition-developed autism. Also developed s/s of another illness/cold < 1 week after vaccination.
pt recv vax 12DEC96 & same day exp swelling & redness in the area of the deltoid muscle @ inj site;
5 minutes after the shots were received, both hands started tingling. White and red patches appeared and disappeared randomly. Both hands became numb. This lasted for about 1 day after both shots.    Numbness and Tingling continued for 1-2 months on and off regularly.
Presented to ED w c/o of worsening shortness of breath with cough, further evaluation in the ER patient found to be hypoxic and chest x-ray showed multifocal infiltrates.  Patient was tested positive for COVID-19-evaluated by Infectious Disease initiated on IV dexamethasone and remdesivir, abx, zinc & O2. Weaned to RA on dc.
After having a fever, chills, and aches, as those symptoms faded away, I began to perceive a distinct odor. It was intermittent and then was constant from Sunday morning until Friday morning. The odor was strong and differed at times. It varied from a minty smell, to a musty basement type of smell, to a chemical/bleach smell, to something unidentifiable but unpleasant. At times I also could taste it in the back of my throat. It was so strong that I gagged frequently on Tuesday and Wednesday at its peak. I could smell and taste normally, but in the absence of an external smell, I had this other odor in my nose. On Friday, the smell was noticeably less strong and intermittent. 13 days after vaccination, I still sometimes smell it although it is brief and mild. I am tested for COVID weekly, so I know it was not due to the virus.  1/21/21  Vaccine dose #1 1/22-23 Fever, chills, aches, fatigue, mild cough 1/23 Intermittent smell began 1/24-28 Constant perception of bad odor from wake to sleep 1/25 Tested negative for COVID via PCR test 1/29-Present Gradual decline of smell intensity and frequency
Rash on torso, groin, limbs and neck. Does not appear to be itchy. Mild fever. As of this reporting it has not subsided.
pt recv vax; local redness noted; redness and swelling also noted and resolved later;