chrisvoncsefalvay/vaers-outcomes huggingface dataset:
mild swelling on right side of the face; Very mild headache; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (mild swelling on right side of the face) and HEADACHE (Very mild headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypersensitivity, Allergy to topical drugs (fingers swelling, cracking and bleeding), Vitamin C (facial swelling), Allergy to topical drugs (eye swelling  and rash) and Hashimoto's disease in 2020. Concomitant products included FISH OIL for Joint ache, AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3) and THYROID (ARMOUR THYROID) for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (mild swelling on right side of the face) and HEADACHE (Very mild headache). The patient was treated with METOPROLOL TARTRATE (METOPROLOL - 1 A PHARMA) (oral) on 06-Feb-2021 at an unspecified dose and frequency and FLECAINIDE ACETATE (TAMBOCOR) at an unspecified dose and frequency. At the time of the report, SWELLING FACE (mild swelling on right side of the face) and HEADACHE (Very mild headache) outcome was unknown. Not Provided          This case was linked to MOD-2021-034347.   Reporter did not allow further contact
Pain in arm (intense), overall sick feeling and nausea. Lost about 15 lbs., vomiting, aching, shortness of breath (intense). Heart pains, spinal contraction/sore muscles, disorientation, at times, dizziness, and numbness. A very disorientating experience and my arm still hurts.
Heart/chest pain (12 hours), extreme chills (2 hours), fever (9 hours), headache (12 hours), arm pain, pale face and nausea (12 hours).
Temp of 101F, Edema, warmth at site. Tenderness to touch.
Pt was given dosage for a 12yr old. No symptoms or reactions at time of vaccine given. Provider spoke with mom and advised.
pt devel knot in thigh, lt leg longer than rt leg;pt frequently falls when walking;mom noted lt leg being longer;swings lt leg out when walking;swollen area hot & hard p/vax;bowels became loose;ROM of the hips is limited;hip dislocation;
Pins/needles in lower right arm. Numbness in right are.  Occurred 3 times. The third time full feeling has not returned.
First dose: Pain around injection site spread to shoulder. Started within one minute. Kept me awake the first night and lasted 3-4 days on and off. Very intense headache for the first few days. Ears felt funny. Hard to think. Felt like my brain was swollen. It was most intense after the first shot but hasn't gone away. Head/neck ache; muscle aches; back pain; stomach pain lasted about a week. Wheezing cough has come and gone since the first dose. Brain fog; lightheadedness; dizziness; irritability has not gone away five weeks later. Phantosmia: persistent and distracting olfactory hallucinations. Worst between the first and second doses but hasn't gone away completely. General inflammation: old injuries hurting, swelling and swollen lymph nodes around my body.  Second dose: Pain in injection arm, lasted only about two days. Flu-like symptoms for the first week. Fatigue; headache; cough; muscle aches; fever; intense nausea. Starting about three days after the second dose, I could barely eat for three or four days. This was similar to when I was on chemotherapy. Fatigue (any physical activity is tiring). Difficult to go to work. If I do, then I have to lie down the entire next day. Any exertion makes all other side effects worse.
Diagnosed with Polymyalgia Rheumatica by Rheumatologist. Extreme pain in thighs, hips, wrists, hands, shoulders (right worse than left).  Extreme fatigue, headaches, swollen right hand knuckles. to rest at least 1-1/2 to 2 hours per day because of fatigue and lack of energy.
no adverse symptoms; patient received VARIVAX on 08-JAN-2020 after the patient received MMR II on 20-DEC-2019; This spontaneous report was received from a licensed practical nurse referred to a 5-year-old female patient. The patient's pertinent medical history, drug reactions/allergies were not reported. The concomitant medications included sterile diluent (STERILE DILUENT). On 20-DEC-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route, indication, lot # and expiry date were not reported) for prophylaxis. On 08-JAN-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot # R002051, expiry date 22-JAN-2020, via subcutaneous route for prophylaxis (inappropriate schedule of product administration). The reporter stated that, it was too short of an interval between the doses. There was no adverse effects reported.
He had a headache and he began sneezing and coughing.  He took a home COVID-19 test and it was positive.  It developed within 3 days deep in his chest.  He had a bit of a sore throat, but not constant.  He was fatigued.  Then about 5th day, after we talked to the doctor, we agreed that Paxlovid would be good.  He began taking it on June 30th.  He began to feel better within the next two days.  After another 4 days he was much better.  He had a funny taste in his mouth from the Paxlovid.  After he finished the Paxlovid the taste was gone from his mouth.
1/27/23 I began getting sniffly and it became worse. I was congested and felt like I had been hit by a truck. I had 100.3 temperature. I had lost my sense of smell. I took an at home COVID test and it was positive. On 1/28/23 I went to urgent care. I had a positive COVID test and was prescribed PAXLOVID. I began taking the PAXLOVID that evening. On 1/30/23 my heart was racing and I felt so much better, so I stopped taking the PAXLOVID. I had taken two and half days of the medication. I started feeling better the day after I started taking the PAXLOVID and my sense of smell had returned.
3 hrs p/immun, pt awakened w/unusual crying, as in pain had generalized trembling plus arm clonus & jumpy eyes; did not respond to moms voice; no fever; lasted 3-5 min;
pt recv vax;started crying from 1pm-4pm; was not easily consoled during crying episode; cont to cry & whimper when comforting;
full body hives, swelling and warmth in hands and feet, irritated scalp, pressure sensitive skin resulting in more hives, diffuse itchiness
Severe headache and body aches, severe chills - started the morning after the vaccine and lasted about 48 hours
prefilled syringes were stored at room temperature between 60-73F; administered with the vaccine from prefilled syringe prepared last 06Aug2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with the vaccine from prefilled syringe prepared last 06Aug2021) and PRODUCT STORAGE ERROR (prefilled syringes were stored at room temperature between 60-73F) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00186502 and 017C21A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with the vaccine from prefilled syringe prepared last 06Aug2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (prefilled syringes were stored at room temperature between 60-73F). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with the vaccine from prefilled syringe prepared last 06Aug2021) and PRODUCT STORAGE ERROR (prefilled syringes were stored at room temperature between 60-73F) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2021: Follow up received and contain non significant information.
post-herpetic neuralgia; herpes zoster; Information has been received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 05-OCT-2012, the pt was vaccinated at her local pharmacy with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot #, and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unknown dates, the pt was treated by healthcare providers for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: herpes zoster and post-herpetic neuralgia. The outcome of the events was not reported.  The reporter considered the events of herpes zoster and post herpetic neuralgia to be related to zoster vaccine live (ZOSTAVAX).
Patient said he felt like he was going to pass out, went to get him juice, when returned patient was leaning back in chair with his head flung back. Patients skin was pale and greenish, was non-responsive. Patient twitched once or twice, and then came to. Patient drank juice and ate some chocolate and said was feeling ok. Color came back and he said he felt fine before leaving the office.
Patient age 17 and not 18 for Moderna. Patient came back to clinic for second dose of Moderna. I saw that he was 17 when I verified his age and recognized that he needed to Pfizer. Patient denied any adverse reaction post Moderna vaccine. Patient is approximately 6 foot and 200 pounds.
Severe stomach cramps, dehydration. Took magnesium citrate next afternoon to go to bathroom
Patient presented with following symptoms upon receipt of vaccine: - Asthmatic symptoms, trouble breathing,  - Adult EPI-PEN Administered to PT (G201002x exp: Jan22)    -0.3 mg Left Thigh  PT Transported to Hospital Ambulance at 0905hrs
I gave a second Tdap for a primary series instead of a Td. I also gave MENVEO at age 14 when she had had a previous unspecified meningitis immunization at age 11.
From telephone contact received from reporting physician stated that a 2 month old female patient received a Tripedia, an IPOL, a Prevnar, a Hepatitis B and a Hib vaccination on 6/13/01. Hours after the vaccination the parents of patient called physician's office stating that all the patient is doing is sleeping. They had to wake her to feed her; however, she did not take the bottle. Physician also stated that the parents called the next morning and said the child slept all through out the night and they had to wake her again in the morning to feed her. She took the bottle and went back to sleep. Physician reports the child is very drowsy but has no other symptoms.
extreme temperature for an unknown cumulative time of exposure; Initial information received on 13-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves an 8 years old female patient who received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and reported that extreme temperature for an unknown cumulative time of exposure (product storage error).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 12-Sep-2019, the patient received one dose of suspect 0.5 ml INFLUENZA QUADRIVAL A-B VACCINE lot UJ237AB and expiry date: 30-Jun-2020 via unknown route in the right arm.  It was a case of actual medication error due to incorrect product storage.  It was unknown if the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Patien received the booster dose of the Moderna COVID vaccine (lot 069H21A) at 1455. At 1500, patient reported to PHN that she felt hot and dizzy. PHN approached to asses, patient sat in zero-gravity chair and placed supine. Vital signs: respirations 18, pulse 100, O2 99%, blood pressure 130/76. At 1505, PHN offered patient Benadryl but patient declined. PHN educated on following up with provider, ER precautions, and to remain onsite for 30min monitoring from time of reporting symptoms. Patient reported no allergies, medical conditions include vertigo, hypothyroidism, and vestibular migraines. Patient reported she was possibly pregnant. Medications include: synthroid, verapamil, vitamin D, prenatal vitamin, and Valium as needed for migraines. At 1515, patient reported symptoms improved. Vital signs: respirations 16, O2 99%, pulse 82, blood pressure 132/78. At 1530, patient reported symptoms resolved. Patient sat up, continued reporting no symptoms. Vital signs: blood pressure 128/74, pulse 72, O2 99%, respirations 14. Patient stood up, continuing to report no symptoms. Patient left walking with steady gait at 1533.
Patient received her 1st COVID immunization  and shortly after developed chest tightness/pressure, palpitations, and lightheadedness. She reported a previous history of anaphylactic reaction to shell fish and IV dye.
The patient received a dose from a vial more than 30 days on the fridge; The patient received a dose from a vial more than 30 days on the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge) and PRODUCT STORAGE ERROR (The patient received a dose from a vial more than 30 days on the fridge) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge) and PRODUCT STORAGE ERROR (The patient received a dose from a vial more than 30 days on the fridge). On 21-Jul-2021, EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge) and PRODUCT STORAGE ERROR (The patient received a dose from a vial more than 30 days on the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drugs were reported.  Reporter stated that on 20th April 2021 the vial was initially stored in the refrigerator and moved the vaccine into the fridge.Reporter confirmed that none of the patients experienced any side effects.  No treatment drugs were reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Follow-up received contains added reporter fax and HCP confirmed that none of the patients experienced side effects.
more soreness; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included breast cancer and shingles. Concomitant products included Herpes zoster (Shingrix).   In July 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient had more soreness after the 2nd shot. It resolved quickly after the first and took about a week to resolve after the 2nd.   The reporter consented to follow up. This case has been linked with US2020180914 and US2020180921, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020180914:same reporter US-GLAXOSMITHKLINE-US2020180921:same reporter
Per pt experienced hives on 2 occasions on leg and all over. Her MD stated she could be allergic to the egg components. Pt confirmed she eats eggs and has received flu vaccine in past.
Came to ED due to progressively worsening intermittent pleuritic chest pain, fatigue, subjective fevers and chills of x6 days duration.  At ED patient found to have elevated troponins and non-specific ST and T wave changes on ECG.  cardiology consulted who recommended continuing colchicine + ibuprofen therapy.
minor headache/neck pain; dizziness; minor headache/neck pain; mnor fatigue; lymp nodes under left arm swelled and became painful; sick for 7 days /in bed for 4 days; 101°F fever; large muscle pain; joint pain; lymph nodes under the left arm swelled till the ribs; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick for 7 days /in bed for 4 days), NECK PAIN (minor headache/neck pain), DIZZINESS (dizziness), PYREXIA (101°F fever) and MYALGIA (large muscle pain) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Undifferentiated connective tissue disease (undifferentiated Connective tissue Disorder likely as a result of chronic Lyme) in 1991. Concurrent medical conditions included Penicillin allergy and Lactose intolerance.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced ILLNESS (sick for 7 days /in bed for 4 days), PYREXIA (101°F fever), MYALGIA (large muscle pain), ARTHRALGIA (joint pain) and VACCINATION SITE LYMPHADENOPATHY (lymph nodes under the left arm swelled till the ribs). On an unknown date, the patient experienced NECK PAIN (minor headache/neck pain), DIZZINESS (dizziness), HEADACHE (minor headache/neck pain), FATIGUE (mnor fatigue) and LYMPH NODE PAIN (: lymp nodes under left arm swelled and became painful). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) in April 2021 for No adverse event, at a dose of 500 mg and PARACETAMOL (TYLENOL [PARACETAMOL]) for No adverse event, at a dose of every 4 hours for 3 days. At the time of the report, ILLNESS (sick for 7 days /in bed for 4 days), NECK PAIN (minor headache/neck pain), DIZZINESS (dizziness), PYREXIA (101°F fever), MYALGIA (large muscle pain), ARTHRALGIA (joint pain), VACCINATION SITE LYMPHADENOPATHY (lymph nodes under the left arm swelled till the ribs), HEADACHE (minor headache/neck pain), FATIGUE (mnor fatigue) and LYMPH NODE PAIN (: lymp nodes under left arm swelled and became painful) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Body temperature: 101 (High) 101°F fever..         Concomitant information was not reported.   This case was linked to MOD-2021-404059 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Dec-2021: Follow up received and it contains information about demographics and patient historical condition and allergies and events were added outcome updated.
Information has been received from a licensed practical nurse (LPN) concerning a 13 year old female patient who on 07-MAR-2007 was vaccinated IM in the right deltoid with the first dose, 0.5ml, of Gardasil (Lot #657006/0188U). There was no concomitant medication. The nurse reported that on 07-MAR-2007, 10 minutes after the vaccine was administered, the patient complained of an upset stomach, and then passed out. The nurse reported that the patient's breathing was normal, but she did not regain conscious or respond to verbal stimulation; "the patient's eyes then "rolled back in her head and she began twitching with seizure like activity." The patient's pulse oximetry results were between 80# to 100%, and oxygen was administered. The nurse stated that 911 was called, and an intravenous line was started with Valium, 10 mg, administered prior to the ambulance arrival. The patient was taken to the ER, but was not admitted, and her symptoms "lasted at least 20 minutes." The nurse confirmed that the patient had recovered on the same day, 07-MAR-2007, and added that on 12-APR-2007, when the patient returned to the office, her exam revealed no symptoms. The nurse considered the events to be life threatening, and an other important medical event. Additional information has been requested.
The person who stuck me with that needle injected the vaccine way too high and the entire dose wound up inside my shoulder socket and now I cant use my arm. I know exactly what happened because I've had my other shoulder broken no less than three times. I know exactly what a shoulder socket full of fluid feels like. There is no discerible swelling it redness, and absolutely none of the bruise-like pain normally associated with any if the dozens of vaccinations a person gets throughout their lifetime. The pain is inside my shoulder and comes from trying to use my arm. It feels like my arm is going to come out if the socket if I so much as move my arm away from my body. If this person is doing this to other people then he needs to be stopped ASAP. No names were given. He is a shorter male, medium build, darker skin, (far as I could tell from the PPE), and spoke with a slight accent.