chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm was sore; Arm was red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm was sore) and VACCINATION SITE ERYTHEMA (Arm was red) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm was sore) and VACCINATION SITE ERYTHEMA (Arm was red). At the time of the report, VACCINATION SITE PAIN (Arm was sore) and VACCINATION SITE ERYTHEMA (Arm was red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not provided. The treatment information was not provided.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Myalgia, vaccination site erythema and vaccination site pain are consistent with the product known safety.
very warm, legs numb & tingling, heavy, face turned red;was weak & had funny feeling in arm, anxious;took Epi then felt better;
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    No relevant concomitant medications were reported. No treatment medication reported.   This case was for 190th patient out of 190 reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
Dizziness, vertigo, brain fog, light sensitivity, eye floaters, blurred vision, unusual pressure in head, drastic increase in headaches/migraines (daily for ~3 months with slight decrease since), skin itchy all over (no rash), pins and needles on back of skull. All of these neurological or sensory side effects have been ongoing for 10 months. The severity has decreased, but flares of these bizarre symptoms will come and go every few weeks. Also irregular, heavy, painful periods with large blood clots have not resolved either.
"Pfizer-BioNTech COVID-19 Vaccine EUA".  observed swelling in the armpit of the left arm.  read information and researched online; determine it was swollen lymph nodes.   Area is not painful or sore, it is tender.   Currently observing area to determine if area of swelling is changing.
Dizziness and fatigue in head developed and lasted for two weeks after the shot that was administered on April 25th..  About 5 days after the shot in the evening, I experienced hot, shooting pain in left leg that felt like a band around my thigh but would sometimes shoot down into my calf and feet. My feet would feel tingly and sore. I experienced shooting pain on and off again in my left and right arms as well as my right leg, but the pain in my left thigh stayed for over a week. The feeling in my legs made it difficult to sleep.  Two weeks after the shot on Wednesday May 12th at 11am, the dizziness and fatigue made me lightheaded and I could not keep my eyes open. My head got really hot and my vision blurred and I could feel my heart beating in my head loudly and all over my body. I tried to walk to my thermometer to take my temperature but struggled to hold things in my hands or walk properly. My sister called my mother who took me to the Emergency Room around 11:50. The doctors took urine and blood samples, X-rayed my chest and did an EKG but could not figure out what was wrong with me and discharged me at 3pm.
I received the SHINGRIX (shingles) vaccine in May 2018.  I received the second shot in July 2018. I was diagnosed with Shingles in February 2019.
Information has been received from a pharmacist via a company representative concerning a male patient over 50 years old. Medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date the patient was vaccinated with a single dose of ZOSTAVAX, administered by an unspecified route (dose number and lot number were not provided). The pharmacist reported that on an unknown date the patient developed a large red bump for 2 weeks after receiving the dose of ZOSTAVAX. Although no treatment was given, at the time of reporting the patient was recovered from the adverse event. The causality assessment was not provided. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced fever and tremor. On an unknown date, the outcome of the fever and tremor were recovered/resolved. It was unknown if the reporter considered the fever and tremor to be related to SHINGRIX. Additional details were reported as follows: The patient experienced uncontrollable shaking and fever following administration of SHINGRIX. The patient notified to reporter of this on Saturday. The reporter had no additional information at the time of reporting. The reporter consented to follow up.
Nausea woke me 10 hours after injection, followed shortly by 101 degree fever, muscle and joint aching. Fever lasted 38 hours, muscle joint soreness is less the 2nd day but still mildly present, nausea continues though finally able to eat a small bit of soup as of 48 hours post-injection.
SHINGLES LEFT ARM, AND CHIN APPEARED 9/14/19 3 DAYS AFTER SHOT. VERY MILD CASE LASTED 2 DAYS. NO PAIN. ITCHING, AND BLISTERS ONLY.
Patient had near syncopal episode post vacc. Treatment with supine positioning, PO fluids, rest. Symp resolved with in 10 minutes.
This case was reported by a pharmacist via call center representative and described the occurrence of weakness in a 69-year-old female patient who received SHINGRIX (batch number E3Z7E, expiry date 18th May 2021) for prophylaxis. On 9th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 10th January 2019, 1 days after receiving SHINGRIX, the patient experienced weakness, fever, headache and chills. On 11th January 2019, the patient experienced injection site erythema, injection site warmth and injection site induration. On an unknown date, the outcome of the weakness, fever, headache, chills, injection site erythema, injection site warmth and injection site induration were not recovered/not resolved. It was unknown if the reporter considered the weakness, fever, headache, chills, injection site erythema, injection site warmth and injection site induration to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The pharmacist reported that the patient experienced adverse reactions after receiving the 2nd dose of the SHINGRIX. Two days after receiving vaccination, the patient experienced injection site erythema, injection site warmth and injection site induration.
Pt left arm is red and swollen in the deltoid region and said it is hard to use his arm.
VACCINE WAS REFROZEN; ADMINISTRATION OF REFROZEN VACCINE; This spontaneous report received from a health care professional concerned an 18 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A, and expiry: 20-MAY-2022) dose was not reported, administered on 11-MAY-2022 for prophylactic vaccination. Age at time of vaccination 18 years old. No concomitant medications were reported.  On 11-MAY-2022, the patient experienced administration of refrozen vaccine. On an unspecified date, the patient experienced vaccine was refrozen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of refrozen vaccine and vaccine was refrozen was not reported. This report was non-serious. This case, from the same reporter is linked to 20220537683, 20220537548, 20220537341, 20220537356, 20220537444, 20220537507, 20220537532, 20220537548, 20220537683, 20220537688, 20220538146, 20220538210, 20220538238, 20220538292, 20220538316, 20220538428, 20220538297, 20220538573 and 20220538480.
Raised area, hot, felt like a lump at shingles injection site-right arm. It started out as a rash, then became a red area on her arm about 3" long and 1" wide. She saw doctor. Doctor said to notify us and Merck. Patient stated that she hadn't taken anything for it and that she doesn't feel it's a reaction but that it's definitely from the vaccine. Unable to clarify from her what that meant. Doctor told her it may never go away.
Patient handed vaccine administration form. Verbally confirmed she would be getting flu shot. Asked what arm and how old patient is. Patient replied ?68 years old, I have a birthday coming up.? Vaccinator said she would get the high dose flu for those over 65 years old. Before injecting left deltoid, vaccinator said aloud ?this is your flu shot?. Administered without issue. Patient told she did not have to wait and replied that she thought this was the covid booster shot. Directed back to front desk to get covid booster paperwork, said she did the flu paperwork online. Pharmacist informed, this vaccinator directed to fill out form
Appeared patient fainted just after vaccine was given, sl diaphoretic pale, recovered quickly after ammonia inhaler was used. Patient rested water was given, left office feeling well.
I was sneezing and had a headache. Very mild sore throat and no fever. Urgent care and did a rapid test COVID 3 weeks after booster from. Regenerome infusion on 10Oct2021.
approx 14 days p/vax pt exp body ache, cfs sx, visual disturbance starting in 1997 & continuing
muscle knot at the injection site; swelling at the injection site; redness at the injection site; Pain at ithe njection site; This case was reported by a consumer and described the occurrence of injection site nodule in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site nodule, injection site swelling, injection site erythema and injection site pain. On an unknown date, the outcome of the injection site nodule, injection site swelling and injection site erythema were recovered/resolved and the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site nodule, injection site swelling, injection site erythema and injection site pain to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported but it could be 63 or 64 years. The patient received her 1st Shingrix dose and had pain, redness, swelling and a muscle knot at the injection site for about the week after the injection. The pain at injection site was recurring and she had nothing else to report. The reporter consented to follow up.
Employee received her vaccine on 2/22/23 and she stated she did fine with the vaccine except having a headache. Employee stated she got up on 2/23/23 with a headache, dizziness, and left sided weakness. Employee stated she was having to really concentrate and think to get her extremities to move. Employee did suffer a fall due to the weakness.. Employee did not receive any injuries from her fall. Employee notified Employee health and was instructed to go to the ER. Employee then called back and stated she was diagnosed with a Complicated Migraine with Hemiplegia or a Hemiplegic Migraine that could be related to the COVID Vaccine. Employee was instructed to follow up with her Primary care provider within a few days and to return to the ER if symptoms worsen.
History provided by:  Patient (NURSES) Unable to obtain history due to :  Acuity of condition Allergic Reaction Presenting symptoms: no difficulty breathing, no difficulty swallowing, no itching, no rash, no swelling, no wheezing, no dizziness and no syncope   Presenting symptoms comment:  SEVERE COUGHING WITH IRRITATION OF THROAT AND WEIRD TASTE IN MOUTH AFTER COVID VACCINE WAS GIVEN TO THE PATIENT.DENIES THROAT CLOSING OR WHEEZING IN CHEST OR OROPHARYNGEAL SWELLING.NO HIVES. Severity:  Severe Duration:  2 minutes Prior episodes: PATIENT IS ALLERGIC FLOOR CLEANER/ STRIPPING DETERGENTS. Context: medications (specify)   Context: not animal exposure, not cosmetics, not dairy/milk products, not eggs, not food allergies, not grass, not insect bite/sting, not jewelry/metal, not new detergents/soaps, not nuts and not poison ivy   Worsened by:  Nothing Relieved by:  Nothing Ineffective treatments:  None tried Treated with epinephrine, methylprednisolone, diphenhydramine dexamethasone and multiple nebulizers
The pt experienced scattered vesicles and papules on chest, arms and forehead. Itching that lasted for 2 days.
runny nose; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose) in an elderly male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ENZALUTAMIDE for Prostate cancer.    No Medical History information was reported.   On 19-Oct-2019, the patient ENZALUTAMIDE (Oral) dosage was changed to 160 milligram once a day. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and ENZALUTAMIDE (Oral) 160 milligram once a day. On an unknown date, ENZALUTAMIDE (unknown route) dosage was changed to 160 milligram once a day and ENZALUTAMIDE (unknown route) dosage was changed to 80 milligram once a day. On an unknown date, the patient experienced RHINORRHOEA (runny nose). At the time of the report, RHINORRHOEA (runny nose) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was reported.  On 17-Nov-2019, the patient ran out of medication for Enzalutamide for a couple of days as the patient did not know how to proceed with getting the refill. It was previously reported that the patient was on second month of taking Enzalutamide and needed 120 capsules each month and had enough of medication, until 21-Dec-2019 and the physician advised the patient to continue taking it.  There had been no restart of medication during that time. The patient had been on Enzalutamide tablets for one year and was taking 2 tablets of Enzalutamide daily (starting dose was 4 tablets daily), reason for decrease was not provided. The patient had a runny rose for the past few months and associated it with the COVID vaccine. The patient had been without medication for 1 month.  The patient had undergone two pacemaker insertion on 03-December.
-Never had any medical problem, but I notice that after I got my second dose of covid vaccine and about 1 or 2 week one side of my leg started to twitch and it has been around 3 or 4 weeks already.  -Side effect when getting 1st dose and send dose just sore arm
The day after the injection I had a quarter sized red area below and anterior to my injection site. It has grown to 5x3 inches.  There is a tiny red area where the needle went in and a red line going to the massive hive or whatever. It is warm, slightly elevated. The last two days it has itched but it?s burning now.  I am using topical hydrocortisone and an H2 blocker. Motrin and cool pack.
Right leg DVT,  below knee had severe swelling, redness of skin and very warm to touch
Marks on his body- rash or raised areas/patches; Allergic reaction; This is a spontaneous report from a non-contactable (Patient). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as 2nd dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization.The patient experienced marks on his body- rash or raised areas/patches and allergic reaction on an unspecified date. It was reported that, patient had the first and second Pfizer vaccine and after the second shot, he developed what he thought to be an allergic reaction. He started getting marks on his body from all over and comes all by themselves and thought these were from the vaccine. Stated they were like a rash or raised areas/patches. He stated rashes or other incidents. Patient had a biopsy done and was waiting to see if this rash was drug related and stated he would call back when he gets his biopsy results if it was drug related. Patient underwent lab test which included biopsy on an unspecified date result unknown. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Expired vaccine used/The vaccines was stored in freezer, we take out one to two vials and place in fridge each day as; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/The vaccines was stored in freezer, we take out one to two vials and place in fridge each day as) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/The vaccines was stored in freezer, we take out one to two vials and place in fridge each day as). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/The vaccines was stored in freezer, we take out one to two vials and place in fridge each day as) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided.  Treatment information was not provided.
This spontaneous report was received from a registered nurse refers to a 57 year old female patient. On 25-MAR-2013, the patient was vaccinated with an expired dose of ZSOTAVAX, (lot number reported as 0564AE, expiry date 21-MAR-2013, route was not reported). Concomitant medications were not reported. Additional information is not expected.
Plus or minus 5 minutes after injection, patient dizzy and almost fainted in store aisle. Sat him up and talked to him for 5-10 minutes. He insisted he was ok. Escorted him & his mother to front door. Called him after one hour to verify ok.
Grand mal seizure, taken by EMS to hospital.  Have no idea if is related to Gardasil vaccine.  Reporting just in case. Had another seizure approx 1 mo later.  Is on medication for seizures now.
mild chest pressure/tightness; chills; slight cough; Within 5 min after shot I had mild dizziness/30min later I experienced moderate to severe dizziness/feeling faint; left hand tingling which subsided/tingling of hands and feet; This is a spontaneous report from a contactable consumer (patient). A 34-years-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm left on 19Dec2020 19:30 at single dose for COVID-19 immunization. Medical history included eczema. There were no allergies to medications, food, or other products. Concomitant medication included patch birth control within 2 weeks of vaccination. Within 5 min (19Dec2020 19:35) after shot the patient had mild dizziness with left hand tingling which subsided. Then 30min later (19Dec2020 20:00) the patient experienced moderate to severe dizziness, feeling faint, tingling of hands and feet, mild chest pressure/tightness, chills, and slight cough. The feeling lasted about 1 hr. Chest tightness resolved after taking Benadryl. No treatment received for other events. The patient was no pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events were reported as non-serious. The outcome of the events was recovered in Dec2020.  Information on the lot/batch number has been requested.
Sinus congestion, lung congestion, and wheezing due to what was diagnosed as a sinus infection. Heavy congestion until prednisone and Amoxycillin were prescribed. Albuterol inhaler used multope times per day. Congestion waned but never completely went away. Congestion flared back up in late November and continues through to today (12/15/2022)
This is a spontaneous report from a contactable consumer via a Pfizer sales representative. A female patient of an unspecified age and ethnicity received first dose of TRUMENBA (lot number and expiry was unknown), via an unspecified route of administration on an unspecified date at a single dose for prevention of Meningococcal B. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced nausea and just felt off. The outcome of the events was recovered.
Loss of control of my bladder. Couldnt walk. Taken to urgent care. Cardiogram was done. BP was over 300. Taken to Hospital, CAT scan confirmed that I was NOT having a stroke. after 4 days I was fine
fever 101, heart rate over 100,  joint and muscle aches, chills, unable to sleep.   lasted from 10 pm until 8 am next morning.    Temperature reduced to 99, other symptoms reduced.   48 hrs after injection,  back to normal.
On Wednesday, feet were itching, red with blisters and noticed that it was all over body and went to ER. Seen by Internal Medicine doctor and treated with Atarax and quarantined in quarters. Returned to ER every other day for observation. On 2nd return, released from quarantine. Maintained on convalescent leave 48 hours. Hands and feet peeling but no pain. No follow-up. Blister/skin burning and itching "blisters very tiny".