chrisvoncsefalvay/vaers-outcomes huggingface dataset:
First dose over 95 days ago; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First dose over 95 days ago) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Myocardial infarction. Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) from December 2020 to an unknown date, ATORVASTATIN CALCIUM (LIPITOR) from December 2020 to an unknown date and ASPIRIN [ACETYLSALICYLIC ACID] from December 2020 to an unknown date for Myocardial infarction.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT DOSE OMISSION ISSUE (First dose over 95 days ago). At the time of the report, PRODUCT DOSE OMISSION ISSUE (First dose over 95 days ago) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-241054 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Additional information received included patient demographic details which included race, ethnicity, height and weight; relevant medical history details which included acute mild myocardial infarction; concomitant medication details including Plavix, Lipitor and aspirin; suspect vaccine details which included route of vaccine administered and re-challenge details.
Heat & erythema approx 2cm x 2cm to the (R) deltoid distal to injection site.
Tingling in left arm to fingers tips of fingers felt numb lasted about 24 hrs had pain at injection site for about 1 1/2 weeks. Took Advil for pain.
This case was reported by a healthcare professional (Certified Medical Assistant) and described the occurrence of extensive swelling of vaccinated limb in a 6-year-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline). Historic vaccination included diphtheria and tetanus toxoids and acellular pertussive vaccine ;GlaxoSmithKline;unknown;unknown given on 3 August 2009, 7 September 2010, and 1 August 2011. Concurrent vaccination included MMR vaccine (non-gsk) ;non-GSK manufacturer;unknown;left thigh given on 26 July 2012. The subject had no reactions to her three prior INFANRIX vaccinations. On 26 July 2012 the subject received 4th dose of INFANRIX (intramuscular, right thigh). On 26, 27 or July 2012, less than one week after vaccination with INFANRIX, the subject experienced extensive swelling of vaccinated limb, injection site hot to touch and sick in stomach. The subject was experiencing swelling in her thigh from above the knee to groin, worse in the lower half of the thigh (not at the injection site) and it was hot to touch. The subject was not experiencing fever, but was sick to stomach. At the time of reporting the events were unresolved. This case was associated with pharmaceutical product complaint. The Certified Medical Assistant (CMA) reported that the office received a new box of INFANRIX with lot AC14B157CA on Thursday, 26 July 2012. Four children received doses from the new box and all were given intramuscular shots. Three different individuals administered the shots. The CMA reported that three of the four subjects were having a "sizeable local reaction". According to the CMA, two subjects received the vaccine on Thursday, 26 July 2012 and two received the vaccine on Friday, 27 July 2012. The CMA explained that the subjects who received the vaccine on Thursday were having a "stronger reaction". This case is one of the subject's who received the vaccine on Thursday. See cases A0989437A, A0989438A and A0989439A for details on the other subjects. Follow up received from the healthcare professional (Certified Medical Assistant) on 15 August 2012. The CMA reported that the physician was concerned that something was wrong with the reported lot (AC14B157CA) of INFANRIX since four patients experienced reactions after receiving the vaccination. The office requested replacement for the 3 boxes of vaccines with the reported lot. According to the product complaint investigation results reported by GSK Biologicals quality assurance on 21 September 2012, the product complaint was assessed to be unsubstantiated.
Headache, body aches, nausea, diarrhea, fatigue, chills sore lt arm and neck
Body aches; Mouth is tasteless; Tension inside body; Body was shaking; Shivering; Pain in the left arm; A spontaneous report was received from a 42-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced body aches, pain in the left arm, shivering, body was shaking, mouth tasteless and tension inside body.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 06 Jan 2021, at 2:30pm, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 06 Jan 2021, the patient experienced body aches, pain in the left arm and shivering and body was shaking when he woke up. He stated that his mouth was tasteless and tension inside body. The patient took two (unknown dosage) Tylenol as treatment.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the events, body aches, pain in the left arm, shivering, body was shaking, mouth tasteless and tension inside body, were unknown.; Reporter's Comments: This case concerns a 42-year-old male who experienced NS unexpected events of pain, pain in extremity, tremor, tensions and taste disorder and NS expected event of chills.  Event onset occurred on Day 1 after the first dose of mRNA-1273. Treatment included Tylenol. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
8-10 chicken pox on back, 3-4 on face and 2 on legs.
Describes tingling at injection site still 3 1/2 months later. Not severe, just noticeable.
High fever, headache, extreme shivers, sweats, shortness of breath, clammy skin.
I woke up the next morning feeling dizzy, nauseous and complete hearing loss in right ear.
This case was reported by a physician, via another manufacturer (Merck) and described the occurrence of seizure in a 9-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of HAVRIX (details unknown). At an unspecified time after vaccination with HAVRIX, the subject experienced seizure. A healthcare professional also reported that the seizure had not been diagnosed. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified. Follow-up was received from the healthcare professional on 12 July 2011: The physician's office had no further information as they were unable to identify the subject who this report was pertaining to. Follow-up was received from a healthcare professional on 19 July 2011: The physician's office was again noting they could not provide further information as they were not able to identify who the subject was based on the limited details provided to us with this report.
This spontaneous report as received from a certified medical assistant refers to a unknown number of patients of unknown demographics. On 27-JAN-2015 the patients were inadvertently administered VARIVAX (Merck) (dose, route and lot # not reported) that had been improperly stored. No adverse effects were reported. Additional information has been requested.
Pt admitted on 08/12/2021 with symptoms of failure to thrive. Pt is covid positive. Hx of dementia. She was diagnosed with COVID two days ago after being exposed to caregiver who was positive. The is vaccinated, but has had some malaise and low grade fevers.  No oral intake for several days prior to hospitalization.   Pt was given IV fluids and discharged on 8/14/2021.
LVN stated "that the patient's parent registered the child to be vaccinated on 8/14,It was discussed that we didn't have the Moderna vaccine, Pt filled out the paperwork , computers were down on that day. If the computers were not down we would have seen that the child was 4, however unfortunately due to the parent putting  that her child was 5 on the paperwork the 5-11 Pfizer was given,
Numbness in whole face, left arm, and lower right leg, pins and needles, could no close hand for an hour, heart flutters, elevated heart rate,  swelling in Breast and armpit same side as injection
No further AE.; Nurse calls to report PNEUMOVAX 23 administered to patient after expiration date  No further AE.  No PQC; This spontaneous report has been received form a nurse, regarding a 65-years-old male patient. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 28-JUN-2023, the patient was vaccinated with an expired Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) injection, as prophylaxis (lot number: U027357, which was determined to be valid as syringe, with an expiration date on 25-MAR-2023) (strength, dose, scheme, route and anatomical location of administration were not reported).  No additional adverse event was reported.
Received Vaccine on 12/28/2020, reported headache and slight rash on back 12/30/2020 starting about 12 noon.   Reports taking naprosen and benadryl and put cold compress on back.   on 12/30/2020 at time of this report all is resolved.   Recipient did not report side effects to medical staff until today prior to this report being submitted.
Case number PHEH2014U8024305 is an initial spontaneous report from a nurse received on 02DEC2014, with a follow up received from nurse on 19JAN2015. This report refers to a 43 year old female patient. Her medical history was not reported. Concomitant medications were none. The patient had tolerated the vaccines well in the past. The patient was vaccinated with FLUVIRIN 2014/2015 (seasonal influenza vaccine, batch number: 14511P, expiry date: MAR2015) intramuscularly at a dose of 0.5 ml into the left deltoid on 05NOV2014. The nurse reported that FLUVIRIN 2014/2015 was stored at 49 F for one hour and 15 minutes before administration to the patient. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degrees F for 1 hour and 15 minutes. No adverse reaction was reported following this maladministration (incorrect storage of drug). No further information was provided. Follow up received from nurse on 19JAN2015: updated site of vaccination and reporter comment.
COVID arm; It's kind of bump, red, and itches; Rash that developed a week later at the injection site; It's kind of bump, red, and itches; It's kind of bump, red, and itches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm), VACCINATION SITE PRURITUS (It's kind of bump, red, and itches), VACCINATION SITE RASH (Rash that developed a week later at the injection site), VACCINATION SITE SWELLING (It's kind of bump, red, and itches) and VACCINATION SITE ERYTHEMA (It's kind of bump, red, and itches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (COVID arm), VACCINATION SITE PRURITUS (It's kind of bump, red, and itches), VACCINATION SITE RASH (Rash that developed a week later at the injection site), VACCINATION SITE SWELLING (It's kind of bump, red, and itches) and VACCINATION SITE ERYTHEMA (It's kind of bump, red, and itches). At the time of the report, VACCINATION SITE REACTION (COVID arm), VACCINATION SITE PRURITUS (It's kind of bump, red, and itches), VACCINATION SITE RASH (Rash that developed a week later at the injection site), VACCINATION SITE SWELLING (It's kind of bump, red, and itches) and VACCINATION SITE ERYTHEMA (It's kind of bump, red, and itches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.    Reporter did not allow further contact
This spontaneous report as received from a physician via a company representative refers to an unspecified number of "young adult" patents of unknown age and gender. No information about the patients' medical history and concurrent conditions was reported. On an unknown date, patients received hepatitis B vaccine (manufacturer unknown) (strength, dose, frequency, route of administration, lot # and expiration date were not provided). No concomitant therapy was reported. On an unknown date, patients were found to have not seroconverted following the administration of hepatitis B vaccines (manufacturer unknown). The outcome of reported event was unknown. Product quality complaint was not involved. The relatedness between the lack of seroconversion and received hepatitis B vaccine (manufacturer unknown) was not reported. Additional information has been requested.
Patient called 11/10/14: 10/31/14 developed muscle aches, arthralgias and pain in rib cage: now improving slowly v. slightly red non-painful. 11/5/14 noticed pea sized "welt" upper left arm - "pea sized". Went to health care provider and given KEFLEX. 11/7/14 developed 100.7 degrees fever, chills, muscle aches -> went back to PCP who advised further evaluation -> went to ER and ultrasound done-> not fluid-filled, no lymph node involvement and given BACTRIM and KEFLEX x 10 days.
13APR94 c/o numb hands, arms, legs, unable to hold pencil or wash & care for hair; seen by MD 18APR94 not better seen by neurologist 21APR94; blood work & EMT office able to hold pencil as of 28APR94 will contact again for follow-up;
Diarrhea Started 48 hours later Dr says chronic non specific diarrhea. (Treatment: High Fat diet) undigested food particles in stool. Hard Rd Knots on legs 1 lasted over 6 weeks.
wheezing, hoarseness, pain in legs and fever of 102+ degrees and Mom unable to get it down
Lower lip and chin swollen, a few patches of hives (size of a dime) on back of left leg.  I took Atarax 25 mg tablet and swelling receded after 6 hrs.
Fatigue, Injection site pain, joint pain (full body), muscle cramps (full Body), Fever, Lethargic, chills. Treated with Ibuprofen, lasted 2 days
Headache, Myalgia, Localized pain, itching, redness; chills, fatigue Narrative:  Other Relevant History:
Patient reported developing 4-5 dime- sized welts on left arm and 2-3 dime-sized welts on upper right arm starting two days after vaccine administration. Welts were accompanied by itching. Patient reports that signs/symptoms started to subside on 2/8/14.
About 8 hrs after vaccine administered - swelling was noted with redness, warm to touch and area measure 10.5x 9cm. Can use arm with discomfort.
Severe back ache in the Kidney area on both sides. This pain lasted for 6 days. Headache and sinus type issues which lasted for 3-4 days.
did not received 2nd dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 01 March 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: did not received 2nd dose).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 09-OCT-2023 The patient reported that he/she took Shingrix vaccine on 1st March 2022 and did not had the second dose. The patient would like to complete the treatment and enquired to recommend taking the final dose now or restart with 1st dose and then also take 2nd dose (total of 3 doses). Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 63-year-old female patient who received SHINGRIX for prophylaxis. On 27th August 2018, the patient received the 1st dose of SHINGRIX. On 27th August 2018, 6 hrs after receiving SHINGRIX, the patient experienced pain in arm, chills, headache and fatigue. On an unknown date, the outcome of the pain in arm, chills, headache and fatigue were recovered/resolved. It was unknown if the reporter considered the pain in arm, chills, headache and fatigue to be related to SHINGRIX. Additional details were reported as follows: About 6 to 7 hours later, the patient experienced events which resolved within 48 hours. This case has been linked with US2018178314, reported by same reporter.
Wrong vaccine given, Patient was given the Pfizer orange cap 5-11 year old dose, instead of the Pfizer purple dose 12+
28nov89 pt vax hepta B. pt ex. pain at inject site. 28dec89 pt vax 2nd hepta B. pt ex prolonged pain and tenderness at inject site which lasted 2 days to 1 week.  Pt recovered.
Patient was given the pediatric covid moderna vaccine (purple border) in place of the bivalent by mistake. No adverse events reported.
Information has been received from a 31 year old female pharmacist who in December 2010, gave 4 doses of ZOSTAVAX (Merck). In January 2011, the pharmacist developed muscle pain and "some bumps" and was diagnosed with shingles. The pharmacist sought unspecified medical attention. The outcome was unknown. No further information is available.
pt recv vax AUG95&FEB96 a test showed that the pt had not seroconverted;no further details were provided;
Pt called the reporters office on 11MAY90 c/o redness & swelling at injection site after receiving TD. Pt was examined by the MD on 15MAY90 treated w/ice pact for 2 days has recovered.
Patient came in asking for moderna 1st dose. checked registry and showed no dose given. Asked verbally if pt received another dose before and they said no. When processing the claim insurance said they received Janssen 4/8/21 at pharmacy. Confirmed with pharmacy
Patient reports arm is very itchy, red and that she feels a small lump at the injection site. No fever, area is not hot to the touch.
Patient received the Covid-19 vaccine (Moderna) at 1:05 PM. The patient had no history of any seizures or incidents post vaccination. About 7 minutes after receiving, while going to help a customer, my tech witnessed the patient get up from their seat, pass out, and hit their head on the concrete floor. My tech immediately called me over. The patient was moaning and not initially responding, but breathing. My tech turned the patient on their side and we removed the mask because we thought the patient was having a seizure. My tech held the patient's head to prevent it from hitting anything else. I rushed to get the emergency kit and when I returned the patient was slowly starting to respond. I folded my white coat to place under the patient's head. I asked the patient questions and made sure they could breath. I asked the patient how they were feeling and described what happened. With consent from the patient and wife we called 911. While waiting, we stayed with the patient who then requested to sit up. We had the patient stay laying down but the wanted to rotate to their back. We provided a cold compress to the patient as they stated their head was hurting. The patient was very pale and we provided water to the patient. The patient kept asking what happened and could not remember falling and hitting their head. We relayed this to the EMTs taking patient to the Emergency Room when they arrived who then took over care providing the patient a neck brace and taking patient out on a stretcher.
Soreness in mouth, gums, same side of throat; Soreness in mouth, gums, same side of throat; Soreness in mouth, gums, same side of throat; This spontaneous case was reported by a consumer and describes the occurrence of GINGIVAL PAIN (Soreness in mouth, gums, same side of throat), ANGULAR CHEILITIS (Soreness in mouth, gums, same side of throat) and OROPHARYNGEAL PAIN (Soreness in mouth, gums, same side of throat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GINGIVAL PAIN (Soreness in mouth, gums, same side of throat), ANGULAR CHEILITIS (Soreness in mouth, gums, same side of throat) and OROPHARYNGEAL PAIN (Soreness in mouth, gums, same side of throat). At the time of the report, GINGIVAL PAIN (Soreness in mouth, gums, same side of throat), ANGULAR CHEILITIS (Soreness in mouth, gums, same side of throat) and OROPHARYNGEAL PAIN (Soreness in mouth, gums, same side of throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.    Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: No specific follow-up information recorded.
Headache, CoughWheeze, Diarrhea, Chills,Fatigue Narrative:
8/26/2010 pt with rash on left gluteus and left leg in dermatomal distribution and recently received ZOSTAVAX. Rash consistent with diagnosis of shingles and treated accordingly.
At 10:50 patient was in post vaccination area, states he felt faint, saw spots before his eyes and fainted. Hit head on table then floor. Witness states he was out for 15 sec. then came to. Alert and oriented x3. Warm, sweaty, nauseated pupils equal and reactive, hand and foot grasp equal and strong. HR 60 and regular. C/o HA. Mother called will follow-up with MD.
Twenty minutes after receiving the vaccine I noticed my ears began to feel odd as I was driving home.  Within the hour after the vaccine I had significant tinnitus in both ears and felt pressure/discomfort in both ears and had trouble hearing at normal volume.  I expected this to be temporary and was not initially concerned.  About 90 minutes after the injection I developed a strong headache.  It lasted several hours and then was intermittent but ended at about 24 hours.  The morning after the vaccination I was surprised to still have tinnitus upon waking, along with pressure that at times was painful.  I also realized that I was having even more trouble hearing.  For example I had to turn my car radio, my television, and my other electronic devices up several levels and had a hard time understanding conversations in person.  It has now been 19 days and the ear symptoms have continued.
09/19/22 presents to ED for "shortness of breath". PMHx of "Crohn's disease, CVA, atrial fibrillation, CKD, acute thrombus of left ventricle"