chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Got expiration doses past day 30/ Dose administered from the vial stored in the fridge for more than 30 days; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Got expiration doses past day 30/ Dose administered from the vial stored in the fridge for more than 30 days) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     Concurrent medical conditions included HIV disease (Under treatment for this illness.). Concomitant products included COBICISTAT, ELVITEGRAVIR, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (GENVOYA) and OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for an unknown indication.    On 02-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Got expiration doses past day 30/ Dose administered from the vial stored in the fridge for more than 30 days). On 02-Feb-2022, EXPIRED PRODUCT ADMINISTERED (Got expiration doses past day 30/ Dose administered from the vial stored in the fridge for more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the vials were moved to the fridge on 28 Dec 2021 for 30 day expiration of 27 Jan 2022.   Date of vaccination reported as 02 Mar 2021 and 30 Mar 2021.  Patient did not know if any of the patients experienced any symptoms after vaccination  No treatment medication were provided.   This case was linked to MOD-2022-476392 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2022: Significant Follow-up received. Patient demographic, medical history, administration date, event onset and end date were updated.
Blood clot leading to pulmonary embolism 8/10 severity, emergency  surgery and 3 day CCU stay. Also led to deafness in left ear.
pt recvd vax & devel a 25 cent size enlarged lymph node; No further details are available;
8/27/2012 9:21 AM Mother called and stated the day after child recieved shots there was a cherry / burnt area on back part of her left arm that became larger every day and painful. Mother referred to ER for evaluation and told to give comfort measures like cool cloth to area and Tylenol or Motrin. ER notified.
1/15/21 had itching on the scalp 1/16/21 @8pmdeveloped hives around the neck with the upper lip swelling. Took Tab.Benadryl and Tab.Pepcid .Tab Benadryl continued 3   times. 1/17/21 @9.30pm developed more hives on thighs and lower lip swelling. Centracare was closed. continued Tab.Benadryl and Pepcid. The following day while woke up in morning@8.30am, noted all my face swollen with hives all over the body more on the trunk. seen by PCP. Inj.Solumedrol 125mg IM  given, and a Medrol pack given. symptoms started to subside by the following day and took almost 4 days for the complete recovery. Took a call off from work.
Site of injection became red, swollen and hot. Developed fever 101 degrees and nausea for 2-3 days following injection.
This spontaneous report was received from a Office Manager referring to 2 unspecified patients of an unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On 19-DEC-2016, the patients were vaccinated with a doses of improperly stored VARIVAX, lot # of M024675, expiration date of 18-MAY-2018 (strength, dose number, route and anatomical location were not provided) for prophylaxis. Nevertheless, no adverse effects were reported. The vaccines experienced the following temperature excursions during 26 hours: 52.0 grades Fahrenheit. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. Additional information has been requested.
Vaginal Bleeding. I am 3 years post menopause. This is the same reaction I had with the first dose of the vaccine (which I also reported.) Same timeline of onset, etc.
rash all over body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash all over body) in a  patient of an unknown age and gender 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rash all over body). At the time of the report, RASH (rash all over body) outcome was unknown.            No concomitant medications  was reported. No treatment medications was reported.
LT UPPER ARM PAIN, U/S  07/21/2021UNREMARKABLE, NO DVT RX LIDOCAINE CREAM,  HEATING PAD.  DECLINED PHYSICAL
Client calls Health Department at 11:00 a.m. on 03/17/2020 and states that the location (right arm SQ) where she received her Varicella #2 vaccine on 03/16/2020 is "itchy and swollen". Advised client to come in to the Health Department for evaluation. Client arrives at Health Department at approximately 11:15 A.M. This nurse evaluated clients right arm where vaccine was administered.  This nurse observed a raised, reddened area about the size of a half dollar present on the back of the clients right arm. Client states that the "area is extremely itchy. I asked client if she has any areas of redness or itchiness anywhere else on her body. Client states "no". I advised client to apply an ice pack to the area to help reduce swelling and to take 50mg of Benadryl PO when she gets home. Also advised client that Benadryl could make her drowsy so be sure not to drive or operate heavy machinary while under the influence of this medication. Instructed client to return to clinic if these measures do not help and the area of inflammation gets worse. Client verbalized understanding and is agreeable with treatment  plan at this time. RN.
Daughter was tired and went to sleep not long after shot. Woke up with sore arm around 12:30 am. And went back to sleep after taking Advil. She woke up and took a shower at around 9 am and fainted while showering. She?s never had a history of fainting ever.
This spontaneous report was received from a medical assistant and refers to a currently 12 year old female patient. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9, lot number L016429, expiration date 09-AUG-2017, (dose, route, anatomical location were not reported) after temperature excursion. There was no concomitant medication reported. This is one of several reports from the same source. Additional information has been requested.
HEADACHE Narrative:  PACT nurse: pt reported Mild ADR to last years vaccine requested Flu be listed as Allergy
8SEP92 pt recvd vax & 14SEP92 devel severe pain & loss of motor function in rt arm; treated w/Vicodan;
pt recvd vax; w/in 24 hrs, devel redness, induration, swelling & warmth at site of inject;
fainted after receiving the vaccine as well as hit the floor and suffered a cut on her lip; fainted after receiving the vaccine as well as hit the floor and suffered a cut on her lip; This spontaneous report was received from a licensed practical nurse via field employee regarding a 14 years old female patient. The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not provided.  On an unspecified date in 2016 (reported as 3 years ago), the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (dose, batch/lot#, expiration date and route were not reported) for prophylaxis. On an unspecified date in 2016, the patient experienced fainted after receiving the vaccine as well as hit the floor and suffered a cut on her lip. The patient received unspecified treatment for the events and she sought medical attention and the cut was treated. On the same day, she recovered from the events.  Causality between the events and quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) was not reported.  Upon internal review, event syncope was determined to be medically significant.
Acute vomiting, disorientation.  After he had vomited a few times at around 5:30 am,  he laid back down. He began vomiting again, and I picked him up and he continued to vomit with his eyes closed limp in my arms.  I tried to talk to him but he would not answer.  He eventually answered me after a few minutes, but seemed very out of it.  I took him to the ER where he was treated with Zofran. This stopped the vomiting.  At the ER he was alert and had become more alert to not he 25 minutes drive to the ER.  His appetite was noticeably decreased for first 48 hours.  Crying more easily than normal.  Swelling and redness at injection site.  Ran low grade fever of 99.5 or so within about 6 hours of vaccines which continues to today.  On the morning of 7/15/15 he woke up and complained that his heart was beating very fast.  He told me "mommy I'm not nervous or scared but my heart is beating so fast" and proceeded to cry.  This was right as he woke up.  His heart rate was 150 bps.  He was trembling.  He hadn't eaten much the day before so I got him orange juice and crackers.  He had slept for approx 15 hours.  He drank the orange juice and ate the crackers.  Within 20 minutes he seemed better.  I am an emergency veterinarian so I tried to tell myself maybe he just had a low blood sugar, but these events post-vaccine are concerning, and this is from a mother and vet who believes in vaccines.  I now think 8 vaccines at once is too much.  I would advise anyone else to break them up.  I wish I would have known that the MMR and Chicken pox vaccines could have been given sooner.  I would have given them when he was 4.  However, one month before kindergarten starts there was little time to make vaccine decisions.
3 days after administration of MMR, Varivax, Prevnar, child developed a severe vesicular rash with edema of feet.
Head felt "tight" 30 min after shot, patient felt like she was coming down with something, felt like she did before she came down with the shingles, vaccine site is red, lumpy and hot to the touch. Feels like a blister. Red around site the size of her palm. Stomach is upset.
Information has been received from a nurse practitioner concerning an 83 year old female pt who on 14OCT2003 was vaccinated IM in the right arm with a dose of pneumococcal 23v polysaccharide vaccine. The pt presented to the doctor's office on 16OCT2003, with a red, swollen and tender left arm. The pt's treatment was ice and elevate when needed. The nurse practitioner indicated that the pt called back to the office on 17OCT2003, to say she is a little better. No product quality complaint was involved. Additional information has been requested. It was also reported form the same source that another pt had a similar experience.
Pain in joints, elevated fever, and no sleep due to pain in joints.  Pain started 5 or 6 hours after vaccination.  Husband is still feeling tired and in some pain.  Still feels cold; but currently no fever.
Vertigo; Ear Ache; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) and EAR PAIN (Ear Ache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced VERTIGO (Vertigo) and EAR PAIN (Ear Ache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 15-Mar-2021, VERTIGO (Vertigo) and EAR PAIN (Ear Ache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Bruising at site of injection 1 inch in diameter left arm  red itching right ear, right, left forearms, scalp, waist, abdomen, upper thigh right, left.
red in color; mild rash/annoying; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red in color) and RASH (mild rash/annoying) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A.) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced RASH ERYTHEMATOUS (red in color) and RASH (mild rash/annoying). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (red in color) and RASH (mild rash/annoying) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Given .50ml dose Vaccine (should have given .25ml as it was a booster to J&J)
Sweating, weakness. alert and oriented (remembers his name, date of birth, siblings, high school). was transported to the Emergency room.
First I felt swelling and pain. Currently, I have the arm area red and swollen, I also feel itching in the area.
I received the 1st dose of the Moderna vaccine on 4/13/2021. That day I had pain at the injection site plus itching along with a hardening of the skin near the injection site. On 4/24/2021, I noticed a red spot on my arm around the size of a half dollar. I looked this symptom up online and it looks like it's what's being called "COVID-arm." I had no other reactions from the vaccine and I don't intend to see a doctor unless it worsens.
Erythema Nodosum on lower legs; This spontaneous report as received from a consumer (also reported as a other health professional, conflicting information) via Pfizer refers to a non-pregnant 16-year-old not  patient. No information regarding the patient's pertinent medical history, drug reactions or allergies was provided. Concomitant therapies included doxycycline and "muslin birth control".     On 15-MAR-2021, the patient was vaccinated with the first dose of varicella virus vaccine live  (manufacturer unknown) in the left arm (exact dose, route of administration, lot # and expiration date were not reported) for prophylaxis.   On 27-MAR-2021, the patient was vaccinated with the first dose of (PFIZER BIONTECH COVID-19 VACCINE) in the left arm (exact dose, route of administration, lot # and expiration date were not reported) for prophylaxis.    On 12-APR-2021, the patient experienced erythema nodosum on lower legs. Treatment included "elevating legs prior to vaccination". On 06-MAY-2021, she had a rapid nasal COVID-19 test and it was negative. The outcome of erythema nodosum was reported as not recovered/not resolved.        The causality assessment between the event and the suspect vaccines was not provided.
Shortly after the vaccine I was very fatigued, nauseaed, body aches, bounding HR and a headache but no where as severe as before but GI cramping  was associated this time and I also had a 104 fever but the fatigue and bounding HR lasted longer this time
On 8-3-2022, I started having nasal congestion, sore throat and itchy eyes. On 8-4, I had fatigue, headache, nausea without emesis, body aches, back pain, general ill feeling and a cough. I was on call at the local hospital and I took my own zofran and zembrace. On 8-5, the cough, sore throat and headache worsened. I took 2 home COVID-19 tests and both were positive. I checked my 02 sat and it was 95%. Later that evening, I developed a fever of 100.8 with chills. On 8-6, I continued with fever of 100.7, chills, fatigue, cough, head congestion and slight shortness of breath with an 02 sat of 92% . I began taking generic tylenol cold and flu, both daytime and nighttime version. I also used E-mergency with the elderberry formulation. On 8-7, I had a new onset of joint aches and pains. 02 sat was 91-97%. On 8-8, I went back to my primary care physician's office who gave me a rapid antigen test with positive results and they gave me a bebtelovimab injection. On 8-10, I had increased all over body pain and a clear blister developed on my upper lip and right cheek. I am feeling a little better today and I reporting a breakthrough case of COVID-19.
Fever was 105 and I was alternating MOTRIN and TYLENOL and also giving lukewarm baths. Injection site swelled up to 5-6 inches and was hot to the touch. This went on for 3 days. Fever finally broke and his leg swelling started to go down
Patient reported a lump on the back of her arm, muscle soreness, unable to lift right arm.
Pt. states a rash occurred on his chest day after vaccination. Improving over 5 days. No other symptoms.
Mother called and reported that patient is experiencing sore arm, no reddness at injection site, low grade fever of 100 degrees F, and body aches
pinch nerve on my left leg; leg more frequently with more pain/heat/swollen; leg more frequently with more pain/heat/swollen; leg more frequently with more pain/heat/swollen; This is a spontaneous report from a contactable consumer (Patient). A 58-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0183, patient was 58-year-old and not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 28May2021 at 11:00 as DOSE 1, SINGLE, and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0186, patient was 58-year-old and not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 18Jun2021 as DOSE 2, SINGLE both for covid-19 immunisation. Patient received other vaccine in four weeks as Pfizer biontech. Medical history included osteoarthritis on right leg / pinch nerve on left leg. There were no concomitant medications. No covid prior vaccination, no covid tested post vaccination. No known allergies reported. On 28May2021 at 11:00 AM, the patient experienced pinch nerve on my left leg, leg more frequently with more pain/heat/swollen, leg more frequently with more pain/heat/swollen. No treatment received for events. The outcomes of events were not recovered.  Follow-up (21Sep2021): new information received from a  sponsored program  support. A contactable pharmacist reported that: No new event was reported.  Follow-up(24Sep2021) new information received in response to the mail trail sent regarding the confirmation of below mentioned query. The response included: patient DOB was confirmed.
Pt was given 2 shots on or about 10/3/2018. Pt states she received a hepatitis A shot and flu shot but unsure which she receive in each arm. Pt reports having pain and swelling in R arm x 6weeks. Pt reports having pain and moderate pus discharge from L arm that lasted a few days and has since healed up. Pt reports to office today because she was notified by work she needed additional workup for issues. Pt describes receiving shots with at least 7 other individuals and states person giving vaccine didn't change gloves between them. She didn't think anything about it until everyone started having issues. Issue is still ongoing.
Seen in office on 10/5/18- had severe tenderness redness and tense swelling 24 hrs after vaccines- measured 11 x 8 cm. Severe local allergic reaction vs cellulitis. Begun on Cephalexin 75 mg/kg/d. Recheck visit on 10/6/18- patient has complete resolution of redness and swelling. In retrospect, thought to be a severe local allergic reaction to injection. Has had several influenza injections in the past but no reactions. Last influenza injection was 9/12/16.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally (lot # and dose were not provided). The vaccine also underwent previous temperature excursion, but no details were provided. Digital data logger was not involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA000892.
The pt experienced a fever which began one day post vax, and continued through the next day. The pt experienced pinkness with swelling to the right thigh. Treated with Zyrtec and Elacon cream. Advised not to have the pertussis vaccine in the future.
This spontaneous report as received from a physician refers to an 17 year old patient of unknown gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 10-JUL-2017, the patient was vaccinated with an improperly stored GARDASIL 9 lot # M043731, expiry date 22-JUN-2019 (dose, route of administration were not provided). Data logger was not involved. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA007325: US-009507513-1709USA012766.
Approximately one week after receiving Moderna COVID-19 vaccine second dose, patient experienced dizziness and lightheadedness while engaged in exercise. He was evaluated on June 4, 2021 and treated for suspected BPPV. ECG revealed normal sinus rhythm. He was re-evaluated on June 10, 2021 and subsequently went to the Emergency Room on June 13, 2021 for near-syncope that occurred while driving.  He saw ENT on 22 June 2021, had a normal Brain MRI on June 25, 2021 and was referred to Neurology and Cardiology. He had an unremarkable Holter Monitor, positive tilt test on 13 July 2021 suggestive of POTS. Neurology evaluated him on July 14, 2021 and felt this was consistent with POTS s/p COVID-19 vaccine. He presented again to the ER on July 15, 2021 for continued concerns. He continues to have duty-limiting lightheadedness and dizziness today.
After being administered the first dose of Shingrix, I experienced the following side effects: soreness/pain at the site of the injection; fever which rose to 103.4 degrees; body aches/muscle aches. Fever and body/muscle aches disappeared overnight; soreness/pain at the injection site gradually faded. I am a 64yo male with no underlying health conditions.
Information has been received from a physician concerning his daughter, a 25 year old female who in February 2008, was vaccinated in the left arm with the second dose of GARDASIL vaccine (yeast). Immediately after the vaccination, the patient experienced pain and numbness in the left hand and numbness on the left side of the face that never went away. The physician reported that the vaccination was not administered in the deltoid but was administered in the biceps and triceps area in the patient's left arm. The patient was referred to neurologists and was diagnosed with brachial plexus and Parsonage E28093 Turner syndrome. Numerous magnetic resonance imaging (MRI) studies and other unspecified tests were performed but no results were provided. The patient's symptoms persisted. Additional information has been requested.
patient came in tuesday to report that the saturday/sunday after receiving the RSV vaccine on 9/07 her Right Arm that she received the RSV vaccine in became, red, itchy and warm. Upon looking at the arm when arrived - it was slightly red and looked raised.  Patient said she applied Ice and took a benadryl. She did not receive both vaccines in the same arm.  I told patient noticed that the redness started to travel that it could be cellulitis and would need an antibiotic from the doctor office.