chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse symptoms were reported; Multiple patients received improperly stored doses of VARIVAX; This spontaneous report was received from a medical assistant referring to multiple patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions or concomitant medications were not reported.  On 13-AUG-2020, a patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T002845 (expiration date: 23-JAN-2022) for prophylaxis (additional dosage regimen information was not reported). No adverse symptoms were provided.  The vaccine was exposed to a temperature of 6 to 14 Fahrenheit degrees (7.7 Fahrenheit degrees), for a timeframe of 2 hours and 8 minutes. There was no previous excursions and it was found because of a digital data logger.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2008USA010124: US-009507513-2008USA010123: US-009507513-2008USA010126: US-009507513-2008USA010125: US-009507513-2008USA010135: US-009507513-2008USA010000: US-009507513-2008USA010121: US-009507513-2008USA010122: US-009507513-2008USA010134: US-009507513-2008USA010127: US-009507513-2008USA010128: US-009507513-2008USA010137:
Headache, Myalgia, fatigue Narrative: missed work due to symptoms following second dose
Onset of episodic brief 15-30 sec. repetitive jaw movements with partial opening/closing of mouth within hours of vaccine administration. No obvious change in mental status; decr. responsiveness during episodes otherwise acting normally. No increase in frequency or development of other symptoms over days.
The patient presented to pharmacy on 11/8/12 after receiving vaccine on 11/6/12 with a reaction surrounding injection site on right arm. Area was bright red around site, warm to touch, roughly 4-5 cm diameter, 6 cm long. Patient stated it had progressed over 48 hours and ached. Patient went to PCP and received prescription for clindamycin.
difficulty breathing/ issues breathing; hives; redness; Pressure on her chest; throat tightness; itching sensation in her skin and face/ itchy; burning sensation on her face; rash in her skin; mild discomfort on her throat; allergic reaction; she does not feel as bad as yesterday; chest pain has diminished; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date as unknown, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced pressure on her chest, throat tightness, hives, redness, difficulty breathing, itching sensation in her skin and face, burning sensation on her face, rash in her skin, allergic reaction, she does not feel as bad as yesterday, chest pain has diminished. Patient received the Pfizer COVID-19 vaccine and had a severe reaction and she was no longer in the hospital, indicated that she should use a Blue Epinephrine injector 0.3 mg two unites in case she required it. She wanted to know if this product could cause another major allergic reaction. She took Prednisone (still taking it today) and Benadryl, the chest pain has diminished but since 11:30-12:30 and mentioned that a normal allergic reaction usually gone away after a wile but this one was returned after her treatment. During the call she mentioned that she was worried that she might die sooner if she used the Epipen. It was reported that patient experienced allergic reaction to Pfizer Covid Vaccine with issues breathing, and itchy hives requiring having to the hospital. Events resulted in Emergency room visit. Patient received treatment with Prednisone and Benadryl for the events. Therapeutic measures were taken as a result of pressure on her chest, throat tightness, hives, redness, difficulty breathing, itching sensation in her skin and face, burning sensation on her face, rash in her skin, allergic reaction, she does not feel as bad as yesterday, chest pain has diminished. The outcome of chest pain has diminished was recovered on an unspecified date and other events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Patient bacame cranky cried her developed rash on her lower extrimities.Rash lasted for 1 hour patient consolable 1 n 20 minutes after the administration of the vacccines
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 28-JUL-2014, the patient was vaccinated with M-M-R II, lot # H012572, expiration date: 29-JUN-2014 (dose, strength and route were not reported).  Secondary and concomitant therapies were not reported. Nurse reported that patient received expired M-M-R II. No adverse symptoms reported.  Additional information has been requested.
Received Janssen COVID-19 Vaccine EUA. Had blurred vision, nausea, red rash on arms ,neck and face.  I took hydroxyzine 25mg
Patient was given Pediarix, ActHIb, PCV13, Rotateq. Approximately 3 minutes after she developed hives on abdomen. No facial swelling or respiratory distress. Benadryl was given and she was dischaged after 30 minutes per Dr.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Right arm itchy), VACCINATION SITE PAIN (Pain in right arm at the injection site), VACCINATION SITE SWELLING (Right arm swollen) and MYALGIA (Pain in back of right hand/Pain in back of lower part of arm) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 039821A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension. Concomitant products included METOPROLOL, LOSARTAN POTASSIUM (LOSARTAN POTASIUM FFP) and AMLODIPINE BESILATE for Blood pressure management. On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Pain in right arm at the injection site). On 15-May-2021, the patient experienced VACCINATION SITE PRURITUS (Right arm itchy), VACCINATION SITE SWELLING (Right arm swollen) and MYALGIA (Pain in back of right hand/Pain in back of lower part of arm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PRURITUS (Right arm itchy), VACCINATION SITE PAIN (Pain in right arm at the injection site), VACCINATION SITE SWELLING (Right arm swollen) and MYALGIA (Pain in back of right hand/Pain in back of lower part of arm) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the events was not applicable.
Patients received the vaccination after a temperature excursion; Patients received the vaccination after a temperature excursion; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 vaccination.     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 POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event) outcome 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 assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion).    No concomitant medications were reported.  It was reported that the facility had a temperature excursion in the freezer, the DDL was not recording the temperatures. Storage condition at the time of excursion was Frozen storage. Unbroken cartons of vial size 2.5 and 5.5 ml were involved. Excursion duration was not known. Vials were then stored to the freezer. Visual inspection state was still frozen. Vaccine was already administered. The vial undergo temperature excursion for the first time and patients were involved. Total 40 patients were involved who received Monovalent & Bivalent doses after excursion. No treatment details were reported.
redness still after 3 days on my arm; a bit of swell; inappropriate schedule of vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE ERYTHEMA (redness still after 3 days on my arm), VACCINATION SITE SWELLING (a bit of swell) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    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 VACCINATION SITE ERYTHEMA (redness still after 3 days on my arm), VACCINATION SITE SWELLING (a bit of swell) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine). At the time of the report, VACCINATION SITE ERYTHEMA (redness still after 3 days on my arm) and VACCINATION SITE SWELLING (a bit of swell) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment drugs were reported.The patient had 3rd shot on Friday (unspecified) Moderna. The patient two previous doses were Pfizer.   Reporter did not allow further contact
Had 1st without incident. Dose #2 given 5/1 and then next menses came 1 week early
Narrative:  A 67yo female with PMH that included Hypertension, hyperlipidemia, Cervicalgia, Low Back Pain, Osteoarthritis, Migraine, Depression and Insomnia. On September 23, 2021 the patient's Primary Care physician reported a historical ADR of influenza vaccine induced abdominal pain. The ADR report included a note that read " after PT and then flus shot, had dyspnea and vomiting. Unclear but she was seen in urgent medical setting and was told it might be allergic reaction" No Flu Immunization record. The report did not include which flu vaccine, when and where it was administered.
pt recv vax 11AUG97 came by office 13AUG97 arm was red & swollen 5" x 5" circle;
after first two HPV shots had muscle soreness and slight fever.  After Shot #3 had severe whole body myalgias and stiffness "I can hardly move".  Tender in all major trigger points.  This report made by treating physician, vaccinating physician is patient's OBGYN, so I do not have vaccine lot number information
Initial case retrieved from the scientific literature on 22 September 2011. The authors evaluated clinical-pathological features of 37 infants/children whose parents alleged a relationship between vaccination and death or permanent central nervous system (CNS) damage, and sought compensation through the National Vaccine Injury Compensation Program during the years from 1990 through 1999. CNS tissue was available for evaluation by a pediatric neuropathologist in these 37 cases: 23 males (62%) and 14 females (38%) ranging in age from 1 month to 17 years at the time of death or biopsy. Thirty-three of the 37 patients were dead at the time of the case was evaluated. Most commonly implicated vaccines were DTP or DTaP (33 cases), followed by MMR and IPV/OPV (25 cases each). The authors concluded that there was no obvious relationship between type of vaccine (or vaccines simultaneously administered) to time of onset of symptoms, nature of symptoms, or the lesions found. No CNS lesions were found in 5 of 37 cases. There were a variety of CNS lesions amongst the 32 remaining cases, but pathogenesis of the majority was apparent and not considered a complication of vaccination. Of the 37 patients described in the article, the vaccines received by the eight of these patients were specified. This case captures one patient; and the other seven patients are captured in case numbers 2011-09242, -09243, -09245, -09246, -09247, - 09249 and 2011-09250. A 10-month-old male infant had received DTAP, IPV, HIB (Manufacturers unknown) and Hep B (Other manufacturer) lot numbers, routes, sites and dates of administration not reported. Seven to 10 days post vaccination, the patient developed a stiff neck and fever; he could not sit, roll over or hold this head up, and was quadriparetic. He developed fever and had a cough at 14 months of age, and died at 16 months. CNS lesions consisted of subacute non-demyelinizing viral encephalitis, acute infarctions, and acute anoxic encephalopathy. Pathological diagnosis was unknown. The authors further noted that the two anti-viral vaccines he received, Hep B was a non-neurotropic virus and even natural infection does not cause CNS inflammation. IPV is a killed vaccine (SALK) and on the remote chance that some live virus remained, the CNS pathology was quite different from that cause by polio virus. The authors further noted that the two anti-viral vaccines he received, Hep B was a non-neurotropic virus and even natural infection does not cause CNS inflammation. IPV is a killed vaccine (SALK) and on the remote chance that some live virus remained, the CNS pathology was quite different from that cause by polio virus. Documents held by sender: None.
Large amount of brusing and pain (current pain level  (1-10)=2), did not experience this with first dose of series.
Achy arm from deltoid area down to hand. Very painful. Unable to grip. hand cold and weak. Also shooting pain to hand with tingling and weakness.
On 12/25/20  around 12pm I started to feel sick. I cannot explain, just an overall ill feeling. I also started to feel body aches in my upper body. Through the night, into the next day (12/26/20) my body aches became more intense and I stayed in bed throughout the entire day. I felt very tired and had little energy. Also, I took pain pills to help alleviate the body aches however nothing helped. On 12/27/20 I still felt body aches and these aches were primarily in my upper body only. My neck, arms and across my shoulders were affected the most, My legs did not hurt. On 12/28/20 I started to feel better and was able to get up and around the house more. My energy level improved. As of 12/31/20 I can still feel a slightly "ill" feeling throughout my body but I am better today.
Left thigh (Hib/DTaP combined).  "Progressively increased in size".  14 x 8 cm non tender, firm, warm area on left anterior thigh.  Small area of exzema on back and area of an allergic reaction on abdomen from the nickel allergy.
During the clinic a 13-year-old healthy male was given Moderna vaccine instead of Pfizer.  There were no adverse events at the time of vaccination and none reported by his mother on approximately 28 days later when she went to the pediatrician's office to get his second shot. The physical condition of the child is normal and without injury. The adverse event is that he received the wrong product at time of vaccination. Knowledge of the vaccination given was received from the mother to staff on 1.12.22. Moderna was contacted and gave advisement that the second shot should be given as Pfizer. The mother was notified by telephone and verbalized understanding.
Developed midsternal chest pain and shortness of breath 11/16/21. Seen at Urgent Care x 2, given Ventolin inhaler. Seen at on 11/23/21 for continued chest pain and intermittent  SOB, to r/o myocarditis
Rash at injection site developed one week after receiving the vaccine. Rash is hot to the touch, a bit hard, and slightly itchy.   Not sure if this is related but have a lot of muscle soreness and discomfort in upper back/neck/shoulder area since Sunday 01/03
Information has been received from a medical assistant concerning unspecified number of patients with unknown age and gender. No current or historical conditions were reported. On unspecified dates the patients were administered with doses of PROQUAD (Merck). This is one of several reports received from the same source (MARRS # 1503USA000906 and MARRS # 1503USA007020). Additional information has been requested.
Arash died on March 9, 2021 of cardiac arrest with zero warning, symptoms, signs, etc.
Site injection dermatitis with redness and itching. Provided Topical hydrocortisone cream and PO Benadryl. Patient states providing relief.
Case number PHEH2015US024664 is an initial spontaneous report received from a pharmacist on 20 Nov 2015. This report refers to a 62 year old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN(batch number: 1514801) intramuscularly at a dose of 0.5 ml on 19 Nov 2015. It was reported that the vaccine administered was exposed to temperatures up to 28 degree Fahrenheit for up to 8 hours. The case was reported as non-serious. No adverse events were reported following the maladministration.
covid reaction- SOB, rashes.  HPI:35-year-old male with chief complaint of cough and shortness of breath.  Symptoms have been present since the beginning of May.  He reports this started after receiving his coronavirus vaccine. he reports he gets short of breath with walking short distances as well as he is unable to lay flat as he wakes up coughing and having difficulty breathing.  He denies any heart history.
9 days after shot administered, area began to itch - rash (diffuse) covering 1 1/2 - 2 inches wide occurred in area given. Alcohol wipes reduce itching No blisters.
Case number PHEH2016US029309 is a spontaneous report initially received from a nurse on 07 Nov 2016. This report refers to 78 year old female patient. Medical history and concomitant medication was not reported. The nurse stated that first temperature excursion of FLUCELVAX QUADRIVALENT on 18 Oct 2016 at 52 Fahrenheit (F) for 1 hour, second excursion of FLUCELVAX QUADRIVALENT on 23 Oct 2016 dropped low 6 times to 34 Fahrenheit (F) and lasted 30 minutes each time. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 186866) at a dose of 0.5 ml in to deltoid, intramuscularly on 25 Oct 2016. Third time excursion on 02 Nov 2016 down to 32 Fahrenheit (F) 3 times over the course of 12 hour. It was unknown if vaccine was frozen. Nurse did not know which lot was given to which patient. Upon follow up it was reported that, the patient was not revaccinated. The excursion occurred at night when the clinic closed. No adverse event was reported from the vaccine following this administration error. The seriousness of the event was reported as non serious. Follow up report received from a nurse on 07 Dec 2016: Added batch number (186866) and vaccination site as deltoid of FLUCELVAX QUADRIVALENT and patient demographics (height, weight), updated seriousness as non serious and reporter's comment.
My arm was sore. The first day I had absolutely no energy. In the next 2 days, at around 11:00 I told my husband I did not have any energy. I did not think about the booster. I had to lay down. I slept for like 3-4 hours straight and I never do that. The next day I came out of the shower and suddenly I felt the energy coming out of my body. My legs buckle and I could not stay on my feet. I was slurring, no speech. I was trying to say words and I could see the words in my head but I could not say them. Both my arms and legs felt like jelly. I went to bed and slept for 3 hours. I woke up feeling a lot better. I called the pharmacy and they told me to call their hotline. I told them what happened, and they told me to call my doctor. My doctor told me to go to the ER, which I did on 08/24/2021. By 3:30-4 I could feel my energy coming back to where I normally are. They did a CT scan and checked me for a stroke. Everything was normal but they called the neurologist and he said that I might have had a stroke. He wanted to do further studies. They admitted me for 2 days. They said they could not see any signs of a stroke. They found that people have some weird side effects after the vaccine so they said it was probably the booster. I went home on 08/26/2021. Every day I have an episode, some stronger than others.
pt recv vax MAY97 & 1SEP97 lab eval revealed a lack of seroconversion;
This spontaneous report as received from a medical assistant refers to a 11 year old patient of unknown gender. On 22-JAN-2016, the patient was vaccinated with the first, improperly stored dose of GARDASIL 9 (dose, anatomical location and route of administration were not provided, lot # L016429 with expiration date 09-AUG-2017). The second, improperly stored dose of the vaccine was administered on 22-APR-2016 (lot number L026602 with expiration date: 19-OCT-2017). The vaccine underwent temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Brought back to clinic today 3/9/10 with complaints of rash on abdomen, thighs and legs. Child received Hepatitis A vaccine and PPD yesterday 3/8/10. Physician assessment of urticarial rash. MD ordered/instructed parent to give child Benadryl syrup (OTC) 12.5 mg  by mouth , 3 x day for 2 days then as needed.
Pt came to pharmacy the day after the vaccine was administered. Pt presents with fever, joint pain, itch at injection site, hot to touch. Applied hydrocortisone cream to affected area.
Patient developed redness and splotches to bilateral cheeks. Redness behind left ear and slight redness to injection sites on both arms. BENADRYL (12.5mg/5ml) 1 tsp (5ml) given, and patient observed for 30 minutes in office.
Chills, fever, nausea, vomiting, muscle cramps, joint pain, body aches, felt like my left arm weighed a ton it hurt sooo bad