chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 30 min after injection,  tendon in my neck, left side began to warm, then, the warmth rose to the base of scull.  I started rotating neck, but continued for about 30 minutes.  My neck on that side became stiff and painful.  I continued throughout the pm to exercise my neck .  By bedtime, it was no longer warm.  Still slightly stiff, next morning,  a bit stiff.  By 36 hr, totally back to normhe,  I  am an RN, retired & daughter is RN, active, didn't see reason to contact Dr.
Received second COVID vaccine at 11:30 am on 3/12.  Woke up around 3am on 3/13.  Heaviness in limbs, chills.  Took Tylenol.  Woke up around 7am.  Not feeling any better.  The tip of my tongue felt as if it was dipped in hot sauce.  Slept most of the day.  Chills came back.  Took Tylenol. Today (3/14), better, but still weak.  Under my tongue is very sore.
Pt recvd DTP/OPV on 14SEP92 sl fever, fussy, restricted activity; parents used APAP w/o cool compress, local reaction persisted next 24 hrs; multiple red blotches; itching; inject site very red, warm to touch, local sl, swelling;
Vaccinated SHINGRIX patient who recently had Shingles/ Suspected vaccination failure; Shingles; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Vaccinated SHINGRIX patient who recently had Shingles/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). 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 Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-JUN-2023 The physician had vaccinated Shingrix patient who recently had Shingles. The reporter asked question that should the patient be vaccinated again and if so, how long should she wait to receive the vaccine after contracting shingles. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory details confirming shingles were unknown at a time of reporting.
01/13/2021 vaccination Later that evening, I had numbness in the right arm. I felt like my upper nose and nostrils, I had to breathe thru my mouth; I couldn't breathe normally.  Three days later, I started to feel pain in different parts of the body. It would move all over my body; swelling. I would have to take shoes off due to the swelling. It would switch off every couple of days to include; feet, hips, elbows, etc. My left heel has been bothering me.  Dr. said it may be arthritis and started with pain medication; naproxen, gabapentin. Refer to rheumatologist.
pt devel temp of 104;pt contacted MD & was told to give cold bath;cont w/APAP;next day was seen by MD who told pt not to get anymore DTP;
Patient reports redness, swelling, and welting starting ~2 inches below the injection site one day following injection. 2 days following injection, patient reports it has spread (enlarged). She has been advised to notify her PCP and monitor if the reaction is continuing to spread or now.
5-10 minutes after receiving vaccine difficulty breathing and constricted feeling in throat, called EMT's, they evaluated and after 20 min pt was asked to go to ER and father agreed.
fatigue; nausea; lesions on chin; dose 1 in November 2019 / dose 2 on June 15, 2020; This case was reported by a pharmacist via sales rep and described the occurrence of fatigue in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose in November 2019).   On 15th June 2020, the patient received the 2nd dose of Shingrix. On 15th June 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced fatigue, nausea and skin lesion. On an unknown date, the outcome of the fatigue, nausea, skin lesion and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the fatigue, nausea and skin lesion to be related to Shingrix.  Additional details were reported as follows: The age group was not reported but was captured as adult as per vaccine indication. The patient received dose 2 and experienced unspecified lesions on the chin, nausea and fatigue. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthtening of vaccination schedule. The reporter consented to follow up.
Pt reports blurred vision after receiving vaccine. Not certain on time it began. Currently treating using OTC Wetting drops which provides temporary relief. She will consider contacting her optometrist in a week if no improvement.
mild side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (mild side effects) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Scleroderma and Heart disorder.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION COMPLICATION (mild side effects). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (mild side effects) outcome was unknown.            No relevant concomitant medications were reported  Patient was taking heart, blood pressure medications and statin as concomitant medication.  Patient was on prescription creams for schleroderma  The patient received a 3rd dose on 25Aug2021 on her left arm (lot#01TR17, no expiration date provided) and the same day she had pain on her left arm. On Thursday 26Aug2021 morning she was very sick with chills, fever, a bad headache, she was sick all day, and today 27Aug2021 she feels a little better, she still has a very swollen area on her arm but not as tender, and also today the headache is not as bad.   This case was linked to MOD-2021-300131 (Patient Link).
Chronic fatigue, irregular period, dizzy, fainting, chronic yeast infections, lymph glands swollen, pneumonia, low immune system, allergies, headaches, constant intestinal issues.
No Adverse Event; Moderna Covid-19 monovalent were administered BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered BUD) and NO ADVERSE EVENT (No Adverse Event) in a 4-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Feb-2023, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 08-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered BUD) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered BUD).    Concomitant medication was not provided. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-713271 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2023: Follow-up received and added patient details, vaccine administration date and batch no. On 28-Feb-2023: Follow-up received and had no new information. On 28-Feb-2023: Follow-up received and had no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713271:Patient 12
This 61  year old female received the Covid shot on  3/25/21    and went to the ED on  4/10/21   with the following diagnoses listed below. U07.1 - COVID-19 J12.82 - Pneumonia due to Coronavirus disease 2019
patient developed weakness -mostly in pelvic area; Neurologist suggests that it may be Guillain Barre; pain in hands, knees and feet; pain in hands, knees and feet; low on B12; This is a spontaneous report from contactable other healthcare professional via Pfizer Sales Representative. A 67-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on 28May2019 at single dose for immunization.  The patient's medical history and concomitant medications were not reported. Patient was seen at Primary Care office on 28May2019 and she was vaccinated with pneumococcal 13-val conj vac (dipht crm197 protein). Patient returned to the office on 05Jun2019 with pain in hands, knees and feet. She was admitted to the hospital on 05Jun2019 and remained in the hospital until 07Jun2019. She was told at the hospital she was low on B12 in 2019 and was told to take a supplement. On 08Jun2019 that patient developed weakness -mostly in pelvic area. She returned to the primary care office on 11Jun2019. She came to the office in a wheelchair her weakness was so bad. She was readmitted to the hospital on 11Jun2019 and she is still in the hospital at time of the report. Neurologist suggested that it may be Guillain Barre (2019). The outcome of the events was unknown.; Sender's Comments: Reported events Guillain Barre, weakness and pain in hands, knees and feet more likely represent intercurrent medical conditions unlikely related to the use with the suspected vaccine.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
3 days after the 2nd dose I have experience loud tinnitus symptoms I am now at 11 days with no relief.
Patients grandmother reports that the patient suffered from: swelling, pain, redness and heat at injection site. Patient seen 4 days after immunization with some redness at injection site. No treatment rendered.
Shot given on 2/10/03. Parents noticed evening of 2/11 that there was 1 inch red area around site of shot; feels slightly warm with hard knot.
patient stated he had a flare up of his rheumatoid arthritis in his knee 2 days after the received the vaccine.  He said the flare up was so bad that he was immobile for about 7 days..  the flare up resolved after 7 days. he did not seek out treatment.
Physical weakness, ears ringing, back ache, tingling and numbness in hands and feet, lumps and numbness in throat, trouble walking with coordination. Diagnosed with Guillain Barre Syndrome 8-28-12, Hospitalized 9-4-12 thru 9-8-15 for IVg treatments.  Physical Therapy Sept 24, 2012 thru November to walk again. Continue to have symptoms of fatigue, fuzzy hands, off and on weekly sometimes it subsides for a month then worse again.  Worse March 2015 saw Dr. and discussed residual weakness of GBS and possible Chronic Fatigue Syndrome and possible depression etc.
After receiving Booster, I was infected with Covid-19 with symptoms which included fever, trouble breathing, congestion,  dizziness, head ache, and  muscle pain. Started PAXLOVID on 11/12/2022. Experienced rebound Covid-19 symptoms on 11/23/2022 with an additional positive  rapid antigen test.
This spontaneous report was received from a registered nurse and refers to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 25-JUL-2017, the patient was vaccinated with an improperly stored VARIVAX at a dose of 0.5 (units not specified) from lot # N012132 with expiry date: 17-APR-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA004945.
Subsequently post vax, the pt developed a serious injection site reaction. The reporter stated that 6 pts, out of 15 vaccinees, experienced this event following receipt of vax.
About 24 hrs.  after receiving my 2nd dose of the Pfizer vaccine, I developed extreme dizziness to the point where is could not stand up straight without falling over.
This spontaneous report has been received from a Licensed Vocational Nurse (LVN) referring to unspecified number of patients. On unknown dates the patients were vaccinated with improperly stored dose of PNEUMOVAX23 (dose and route not reported, lot# K008410, expiration date: 26-FEB-2016) (incorrect product storage). No adverse event. This is one of several reports from the same reporter. Additional information has been requested.
Achy; headache in sinus region; Chills; Dry cough; fever is worse; sore throat; This is a spontaneous report received from a contactable consumer (patient) reported that: A 23-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 05Apr2021 14:50 (Batch/Lot Number: ER8733) as DOSE 1 SINGLE for covid-19 immunization (Age at vaccination 23 years). The patient past  Medical history included heart disease from an unknown date and unknown if ongoing his mother has heart disease and anemia from an unknown date and unknown if ongoing there is a family history of Anemia. Concomitant medication(s) included ascorbic acid (VITAMIN C ACID) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On 05Apr2021 the patient experienced dry cough is not as bad it got worse, Headache and chills Caller stated this started when he went to sleep on Monday evening and got worse on Tuesday 6Apr2021 and last night was bad but as of now since Tuesday so on Monday to Tuesday it got worse and this morning, he had a significantly high fever and Achy. Caller stated he took a Tylenol this morning and it has lessened considerably but he feels the fever is coming back and has chills which is an indicator. Caller stated he does not feel that he has recovered completely. The event did not result in Emergency Room and No Physician Office. The patient received Treatment with Tylenol and Mucinex. The event outcome was Not recovered for dry cough, headache in sinus region and Chills, unknown for fever and Chills recovering for Achy.  Additional Communication: Informed caller that this RA agent has a serious of questions to ask in regards to patient details and symptoms the caller has experienced after the vaccine and may be able to answer questions regarding side effects to the COVID 19 vaccine. Provided caller report reference number. Provided caller hours and number. Due to high call volume caller was placed in the queue for details.   No follow-up attempts are possible. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 64-year-old female patient who received SHINGRIX. Concomitant products included hydroxychloroquine. On 26th March 2018, the patient received the 1st dose of SHINGRIX. In March 2018, less than a month after receiving SHINGRIX, the patient experienced injection site discoloration, injection site swelling and fever. On 26th March 2018, the patient experienced injection site erythema, pain in arm, headache, queasy, erythema urticarial and exhaustion. SHINGRIX was discontinued. In March 2018, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the injection site erythema, fever, headache, queasy, erythema urticarial and exhaustion were recovered/resolved and the outcome of the injection site discoloration and injection site swelling were unknown. The reporter considered the injection site erythema, pain in arm, fever, headache, queasy, erythema urticarial and exhaustion to be related to SHINGRIX. It was unknown if the reporter considered the injection site discoloration and injection site swelling to be related to SHINGRIX. Additional information was received as follows: The patient reported that she experienced pain in her left arm which started on the same day of vaccination and lasted for 5 days. The patient also reported that she had a red hot welt at the injection site which also started on the same day of injection and it was continued to grow and was 2 inches in length x 2 1/4 inch breadth. The patient started taking hydrocortisone cream to stop welt and stated that the cream helped to stop the welt from growing. The welt and redness was gone away. However, there was a raised darker area on her arm where the welt was located. The patient experienced headache that lasted all day first day and some of the next day. The patient was queasy for first couple of days following vaccination and queasiness was on and off. The suggested that patient should not get second SHINGRIX injection.
I experienced extreme fatigue and exhaustion a few hours after the injection. My vitals were fine so I went to bed. I slept 8.5 hours and felt fine the next day (today, 20 March 2021).
Complaints of itching at the injection site. No visible hives. Complaints of chest tightness and feeling SOB. No visible signs of respiratory distress observed.
Pt said after getting shot 6 hours later she is getting 102 degree fever. Sore arm and warm to touch.
Within 3 minutes of vaccination, pt began to feel lightheaded and was assisted to lie down on a cot. He c/o a "scratchy throat" and a little trouble breathing; he developed a rash on his neck. VSS were stable throughout episode with SpO2 95-99%.  Pt was administered Benadryl 50mg po x once w/good effect.  The reaction resolved and patient left for home after an hour.
The patient had posterior headache that improved when standing up. Patient drank water and ate crackers. Patient observed and felt better
Inadvertent 2nd flu vaccine; already received seasonal flu vaccine the week before, on 9/30/2021
low grade fever; very weak, I started feeling somewhat better as far as energy; sometimes it feels like my left breast still has swelling; swollen lymph nodes in left arm/ My lymph nodes were very swollen on my left upper arm and my left breast; mild fatigue/very tired; burning sensation at the site of the injection on her left arm; pain in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning sensation at the site of the injection on her left arm), PAIN IN EXTREMITY (pain in the left arm), PYREXIA (low grade fever), ASTHENIA (very weak, I started feeling somewhat better as far as energy) and BREAST SWELLING (sometimes it feels like my left breast still has swelling) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism since 1999. Concomitant products included LEVOTHYROXINE from 1999 to an unknown date for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced BURNING SENSATION (burning sensation at the site of the injection on her left arm), PAIN IN EXTREMITY (pain in the left arm) and FATIGUE (mild fatigue/very tired). On 01-Apr-2021 at 11:00 PM, the patient experienced LYMPHADENOPATHY (swollen lymph nodes in left arm/ My lymph nodes were very swollen on my left upper arm and my left breast). On an unknown date, the patient experienced PYREXIA (low grade fever), ASTHENIA (very weak, I started feeling somewhat better as far as energy) and BREAST SWELLING (sometimes it feels like my left breast still has swelling). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 02-Apr-2021, PAIN IN EXTREMITY (pain in the left arm) had resolved. On 08-Apr-2021, LYMPHADENOPATHY (swollen lymph nodes in left arm/ My lymph nodes were very swollen on my left upper arm and my left breast) had resolved with sequelae. At the time of the report, BURNING SENSATION (burning sensation at the site of the injection on her left arm), PYREXIA (low grade fever) and BREAST SWELLING (sometimes it feels like my left breast still has swelling) outcome was unknown and ASTHENIA (very weak, I started feeling somewhat better as far as energy) and FATIGUE (mild fatigue/very tired) was resolving.            Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow-up information received on 04-AUG-2021, New events added & event outcome updated, Patient Medical history information updated, Vaccine Facility Information Updated.
Father reported that child developed hives on neck and torso and mild swelling of lips and right eye at approximately 11:36am while shopping at a store.  Father reported no breathing difficulties.  Father reported that child was evaluated at the Emergency Room and was given medication and discharged home with a plan to follow-up with the Primary Care Physician.
Patient had ataxia, dysarthria and amnesia of events shortly after receiving vaccine. Went home and slept it off, upon waking in the morning was back to normal. Had acute care clinic appointment 2 days later diagnosed with acute cerebellar ataxia.
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Consulted with the Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare is working with the CDPHE on a compliance improvement plan and has been reinstated vaccination privileges.