chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Side effects from 1st dose of COVID vaccine; Pain; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Side effects from 1st dose of COVID vaccine) and PAIN (Pain) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient experienced IMMUNISATION REACTION (Side effects from 1st dose of COVID vaccine) and PAIN (Pain). At the time of the report, IMMUNISATION REACTION (Side effects from 1st dose of COVID vaccine) and PAIN (Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Drugs were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Treatment medications were not provided.  This case was identified as part of retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Pt. received vaccine 9-24-09. Red rash around injection site occured 9-25-09 with fever and itching. Pt also suffered from severe headache and redness in the left eye. A blood vessel ruptured in that eye. She came by the pharmacy 9-26-09 to ask about symptoms.
Fever; chills; nausea; body aches; headache; sore arm where injection was done; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 32-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3249), intramuscular on 21Jan2021 11:15 AM at single dose in right arm for COVID-19 immunisation. Patient age at vaccination was 32 years. The patient was vaccinated at workplace clinic. No other vaccine was given within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: 9231) intramuscular on 31Dec2020 06:30 PM, at single dose in left arm. The patient has no allergies to medications, food, or other products and had no relevant medical history. Concomitant medications included celecoxib (CELEXA), zonisamide (ZONEGRAN), loperamide hydrochloride (MEDIUM). On 21Jan2021 at 03:00 AM (as reported pending clarification) the patient experienced fever, chills, nausea, body aches, headache, sore arm where injection was done. The events were reported as non serious. No treatment was received for the events. The events were resolving. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.
Headache, Sedation, NauseaVomiting, fatigue and swollen glands. pain at the injection site. Narrative:  Other Relevant History:
Both my identical twin daughters received an oral liquid vaccination as well as 3 shots to both their upper thighs on Friday, June 1, 23018 around 3 pm. Later that evening, approx 4 hours later, my daughter was having what I would now consider being neurological issues, flailing of the arms and legs and twitching. I kept an eye on her and it seemed to calm down some. I was informed that the emergency room doesn't really do much for infants so I did not take her to the hospital. Saturday, June 2, 2018, around 10 am both my girls were running ridiculously high fevers, I called their Pediatrician and informed her about what was happening to them. and she made the comment that they had been switching around the vaccinations because they were causing infants to have high fevers.  She informed me to give them Tylenol. I did and the fevers did go down. Around 2 am Sunday, June 3, 2018, I rechecked their temperature for the 3rd or 4th time and I was happy to see they both had low-grade fevers of 99.2 and 99.1, Patient's being 99.2. I Fed both girls again around 5:30 a.m. they went back to sleep. I went back into their room to check on them because they were being fussy so i put them on their bellies and that seemed to calm them down and they went back to sleep. I awoke around 7:30 a.m. to my baby dead in her crib. She was still on her stomach, I believe she was face down but cannot remember 100%. When I flipped her over she had blood coming out of her nose and she was dead. She was still warm as if she were sleeping, her sister is just fine. We attempted CPR while waiting on the ambulance. She was rushed to the emergency room where they were unable to revive her. I cannot accept that it was caused by anything other than those vaccinations.  We are currently waiting for the Autopsy Report to come back. We had her sister checked out by their Pediatrician the same day and she is just fine.
Eye swelling; Very itchy; Swelling raised was about 4X5 inches; pain; Redness; This spontaneous case was reported by a physician and describes the occurrence of EYE SWELLING (Eye swelling), PRURITUS (Very itchy), SWELLING (Swelling raised was about 4X5 inches), PAIN (pain) and ERYTHEMA (Redness) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Asthma and Atopic. Concurrent medical conditions included Environmental allergy.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN (pain) and ERYTHEMA (Redness). On 25-Mar-2021, the patient experienced PRURITUS (Very itchy) and SWELLING (Swelling raised was about 4X5 inches). On 26-Mar-2021, the patient experienced EYE SWELLING (Eye swelling). At the time of the report, EYE SWELLING (Eye swelling), PRURITUS (Very itchy), SWELLING (Swelling raised was about 4X5 inches), PAIN (pain) and ERYTHEMA (Redness) outcome was unknown.        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.   Concomitant medications were not reported. Treatment details provided dexamethasone and ice.
No ADR, timing ERROR, 2nd dose given 55 days after 1st Narrative: Timing ERROR only, no ADR
No adverse event; administered 13 doses of Moderna COVID-19 Vaccine Bivalent BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine Bivalent BUD) 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)) (batch no. AS7166B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 13-Dec-2022,  after starting , the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine Bivalent BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine Bivalent BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   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 (administered 13 doses of Moderna COVID-19 Vaccine Bivalent BUD).    No relevant concomitant medications were reported.   Administered 13 doses of Moderna COVID-19 Vaccine Bivalent BUD. Vaccines were stored in the fridge since 11-Nov-2022 and administered on 13-Dec-2022.  No treatment information was provided.
Thursday 3-14-13 vaccine provided. Sunday 3-17-13 arm felt hot and itchy, tongue swollen. Went to the ER, given BENADRYL (pill form). Has been taking 1 pill per day for 2 days. States the symptoms are gone.
pt recv vax 30MAY97 & 13JUN97 burning & tingling both hands, later spread to toes;weakness & pain both calves, thighs & facial weakness;diff chewing;IV immune globulin 30ml/day for 5 days;
Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Medium, Systemic: Red sunburn like reaction-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: pt immediately started getting hot, skin from neck down turned red, like a sunburn. pt given benadryl, didn't seem to help. pt stated getting worse. RN gave epinephrine out of an abundance of caution. gave ibuprofen, and pt declined ice packs. Patient redness slowly resolved, but felt jittery post epipen. pt redness was nearly cleared and she felt better as she went to leave ~110pm
This case was reported by a physician via sales rep and described the occurrence of welts in a 73-year-old male patient who received SHINGRIX for prophylaxis. On 23rd March 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 24th March 2018, 1 days after receiving SHINGRIX, the patient experienced welts. The patient was treated with TYLENOL. On an unknown date, the outcome of the welts was recovering/resolving. It was unknown if the reporter considered the welts to be related to SHINGRIX. Additional details were provided as follows: The patients received their SHINGRIX vaccine in the office. On 24th March 2018, the patient woke up on with welts on his back and the back of his right leg. On 25th March 2018, the welts were almost gone. The patient was scheduled to receive his 2nd dose on 3rd July 2018 but the office cancelled until they found out if the reaction was due to the vaccine. Agency was contacted. The office felt comfortable giving the patient his 2nd dose.
Patient did not experience an adverse effect from the booster vaccine. However, after the time of the vaccine administration, I was not aware that a temperature excursion occurred on 1/23/22 where the vaccine was stored for 31.7 hours at the highest temperature of 49.01F.  A previous temperature excursion occured on 1/8/22of 9 hours for the vaccine, which exceeds the cumulative 36 hours according to Pfizer's Summary of Data to Support Inadvertent Excursions to the Labeled Storage Condition  for Frozen or Thawed Unpunctured Vials Chart.
had sx of covid and tested + on 9-5-22  , deceased on 10-5-22.  I dont have any  hospital medical records on this patient.  presented with fever and shortness of breath and according to forms had pneumonia. Had hospitalizations at two hospitals.  9-5-22 admitted at facility and on 9-13-22 admitted at Hospital
For 7 nights following vaccination woke up screaming or wimpering. History of encephalitis as a new born
Had Tdap vaccine in MD offic at 10:30 am on a Wednesday. The next day had 7 days of fever requiring MOTRIN around the clock. This went into bronchitis requiring an antibiotic and cough syrup. Missed 2 weeks work.
This is a 71 y.o. female patient (COVID vaccinated) with a PMH notable for rheumatoid arthritis for which she is immunocompromised on rituximab and Plaquenil, TIA, sleep apnea who presents for evaluation of shortness of breath and weakness x1 week.  She has been tested for COVID-19 on 2 prior occasions both of which have been negative, 09/21/2021 and 09/28/2021.  Today, she presents feeling so weak and shortness of breath that she cannot function.    1st and 2nd vaccines given at local Medical Center No Lot number documented received 3rd shot 08/26/2021
Pt became dizzy after receiving 3rd immunization and slid to floor, not losing csc - she was placed in supine position with legs elevated and given Gatorade and hydration and felt better with 5 minutes - she was observed for 30 min and returned to class. FA was notified. I will check her tomorrow.
Hospitalized due to COVID-19 after being fully vaccinated. Found to have pneumonia.
The next morning I had fever, chills, aches and no appetite - pain and a hard, red lump in upper left arm which continued for 5-6 days. No treatment - just bedrest . Reported to the pharmacist the following Thursday, March 21.
Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Pt past medical history include PE, Hypothyroidism, Benign Hypertension, Hyperlipidemia, Amyotrophic lateral Sclerosis, Chronic Respiratory Failure. On March 9th patient was diagnosed with PNA but his situation was improving. Next few days patient was eating less and lost weight. Also Patient decreased dexterity in his hands and required assistance with feeding/eating. Patient was starting to decline and wife and patient feel that thet will be needing transition to nursing home soon. Meanwhilst patient was also receiving Radicava infusion. Patient was placed in ALF per note on 4/1. No specific note on cause of death. Patient was deceased on 5.17.21.
Left breast pain, edema, erythema. Pain referred to axilla and down left side of chest wall. Pain with any pressure on breast or movement. Started approx 48 hrs post vaccine booster. Symptoms alleviated with ibuprofen, Tylenol, and Bactrim antibiotics.
Moderna COViD -19 Vaccine EUA-  I had COVID in December. I asked if I should still get the 1st vaccine and was told "Yes" when I went on 1/12/21 at 5:00 pm.  12 hours later I woke up with pain/body ache and a  fever of 100 and it lasted for a day. I felt tired the next week.  On 2/12 I had my 2nd vaccine at 5:00 pm and work up at 4:30 in the morning with intense pain  and inflammation around my chest and back and a fever of 102. I am still suffering from pain and inflammation.
Redness, induration, warmth in left deltoid area, 1 day, post vax. Suspect reaction to Diphtheria component. Symptomatic treatment and empiric treatment for cellulitis.
nausea, chills, leg aches.  Tylenol, ibuprofen and Benadryl.  Lasted 48 hours
fever, inconsolable, refused to stand on lt leg off/on x 48hrs;slowly resolved;
Awoke unable to breathe,  severe weight in right lung. Called  Clinic,  advised to go to ER at  Hospital.  Chest CT showed multiple pulmonary embolli in both lungs- placed on Eliquis.  19 days later had severe nausea,  vomiting,  fainting.   Clinic nurse again advised going to ER where cerebral hemorrhage was diagnosed.  Patient life flighted to  Hospital . Eliquis discontinued,  Keppra started to prevent seizures.  In ICU 4/26-28, released to home.
hives on both arms and chest; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives on both arms and chest) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced URTICARIA (hives on both arms and chest). At the time of the report, URTICARIA (hives on both arms and chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history was not provided.  No relevant concomitant medications were reported. No treatment information was provided.
a half centimeter induration, a subcutaneous mass that was tender at the injection site; bump at the injection site; slight tenderness at injection site; This spontaneous report was received from the medical assistant referring to a 23-year-old female patient.  The patient's medical history, historical drugs, previous drug reactions, allergies, concurrent conditions, and concomitant therapies were unknown.  On 24-JUN-2020, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), intramuscular route in the left deltoid as prophylaxis (strength, dose, frequency, lot number, and expiration date were not reported).      On the same date, the patient experienced slight tenderness at injection site. On 11-JUL-2020, the patient experienced an increased in tenderness and a bump at the injection site. On 17-JUL-2020, the patient sought medical attention and the medical assistant noted that the patient had a half centimeter induration, a subcutaneous mass that was tender at the injection site. No treatment was given.  At the reporting time, the patient did not recover from the events.  The causal relationship between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the events was not reported.
left leg and foot have tingled; semi-dizzy after the injection; involuntary bowel movement after injection.; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via an unspecified route of administration in left arm on 17Mar2021 at 12:00, (at the age of 62-years) as single dose for COVID-19 immunisation. Medical history included C5, C6 quadriplegia and spinal cord injury in 1977. The patient did not have allergies to medications, food, or other products. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received other unspecified medications within two weeks. The patient experienced left leg and foot have tingled, felt semi-dizzy after the injection, and I had an involuntary bowel movement moments after injection on 17Mar2021.The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of left leg and food had tingled, felt semi-dizzy and had an involuntary bowel movement was unknown.   No follow-up attempts are needed. No further information is expected.
The hives are itchy; That was my 4th Moderna shot; 4 hrs later, I broke out in hives; My right right leg, below my knee, had a big cluster; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (4 hrs later, I broke out in hives), OEDEMA PERIPHERAL (My right right leg, below my knee, had a big cluster), PRURITUS (The hives are itchy) and OVERDOSE (That was my 4th Moderna shot) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0311921A, 046A21A and 047C21A) for COVID-19 vaccination.     The patient's past medical history included Melanoma (Melanoma in left arm.).   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, the patient experienced URTICARIA (4 hrs later, I broke out in hives) and OEDEMA PERIPHERAL (My right right leg, below my knee, had a big cluster). On 10-Dec-2021, the patient experienced PRURITUS (The hives are itchy) and OVERDOSE (That was my 4th Moderna shot). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) on 10-Dec-2021 for Hives, at a dose of 1 every 6 hrs.. On 10-Dec-2021, OVERDOSE (That was my 4th Moderna shot) had resolved. At the time of the report, URTICARIA (4 hrs later, I broke out in hives), OEDEMA PERIPHERAL (My right right leg, below my knee, had a big cluster) and PRURITUS (The hives are itchy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, SARS-CoV-2 test: positive (Positive) Tested positive for Covid.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No any concomitant medications were reported.
Initial report received on 13 May 2009 from a physician. This subject is participating in a non sponsored Sanofi Pasteur study. This case involved a 13-year-old male subject, with a history of bipolar disorder, benign familial choreoathetosis, high cholesterol and high triglycerides, who was hospitalized on 18 November 2008 through 20 November 2008 for evaluation of pain and swelling of the left side of his face after receiving a dose of FLUZONE SV 2008-2009 (lot number U2803AA) that was administered on 18 October 2008. The route and site of administration was not reported. The subject has two dogs and two cats at home. The subject was taking concomitant medications of Metformin and SYNTHROID (indications not reported) along with DEPAKOTE, SEROQUEL, ZOCOR, PROZAC and simvastatin. The illness started in the first week of November 2008 with left eye pain and photophobia. These symptoms worsened and the subject was evaluated at a health care facility on 11 November 2008, where he was referred directly to the ophthalmology clinic. The subject's photophobia resolved and he was subsequently re-evaluated on 18 November 2008 for swelling of his face over the angle of the jaw. X-ray of the mandible was unremarkable and serology studies for Epstein Barr virus and Bartonella henselae were not diagnostic. At the time of hospitalization, the subject's examination was remarkable for swelling in the left parotid area with significant sensitivity to light touch which resulted in pain in the left parotid area extending into his neck. Group A a-haemolytic streptococci throat culture was negative and the serum amylase level (35 U/L) was within normal values. The subject was started on intravenous Rocephin and clindamycin, and by the second hospital day the subject had decreased swelling and decreased tenderness in the left mandibular area. The subject was discharged home on hospital day three with clindamycin 150 mg three times a day for five days and Tylenol # 3 for pain. The final diagnosis was determined to be cervical adenitis. Recovery status was not reported. Per the reporter, "the event was not related to the FLUZONE vaccine, and the SAE was not going to be reported to the agency, or VAERS. Documents held by sender: None.
Numbness and tingling bil upper extremities, seizure, temporary paralysis R arm. Started day after vaccine given, was observed overnight in hospital.
Initial report received from a healthcare professional on 01 July 2013. A 39-year-old female patient, whose medical history and concomitant medications were not reported, had received an intramuscular first dose of ADACEL vaccine (batch number: U4612AA, site of vaccination was not reported) on 01 July 2013. The patient was pregnant at the time of vaccination. The patient's last menstrual period date was reported as "22 January 1974" and the estimated date of delivery was 03 October 2013. The patient's health during pregnancy, risk factors and treatment for infertility were not reported. At the time of this report, the patient did not experience any adverse event. List of documents held by the sender: none.