chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm soreness for few weeks after the 2nd shot; This is a spontaneous report from a non-contactable consumer or other non-HCP (patient). A 45-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 45-years-old) as dose 2, single for covid-19 immunization. The patient's medical history was not reported. The patient's concomitant medications included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, esomeprazole sodium (NEXIUM) taken for an unspecified indication, fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication, vitamin c [ascorbic acid] (VITAMIN C) taken for an unspecified indication and probiotics taken for an unspecified indication. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation and within 5 minutes experienced severe, dizziness, lightheaded tingling, hot cold flashes all lasting 15-20 minutes, the next 24hrs extreme tiredness. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. After the second shot of the vaccine, the patient experienced arm soreness for few weeks. The patient not received treatment for the adverse event. The clinical outcome of the arm soreness for few weeks after the 2nd shot was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
10/16/23 patient received covid Moderna brand spikevax vaccine in the left arm and prevnar20 in the right arm. No adverse reaction detected then. About one or two days after the vaccine patient began to notice dark discoloration in his left arm that was spreading. He brought it up to his health care team when he was going under a procedure but they said it was just a bruise. By the time he visited pharmacy again on 10/26/23, it had spread all the way down to his hand, starting to discolor his fingers. Patient reported no pain in arm, no fever, no notable difference in mental state, no increased bruising elsewhere, no shortness of breath, no loss of sensation in arm. The only symptom he reported was the spreading intense discoloration itself. Advised patient to go see a doctor, uncertain if he did so.
Immediately after, heart was beating fast and felt dizzy, poison type taste in mouth. In the evening, chills, muscle twitching, headache, joint pain, fatigue. Fever started on the 3rd evening after the shot (53hrs after shot). Still have fever of 101.2 now 67hrs after the shot and having taking 2 Tylenol at 65hours post. Booster has been much worse than 2nd dose for me.
Around the middle of May, my lower back started hurting in the evenings. Then it started hurting in the morning and evening. And then I could not even walk. Then I went to see the doctor; she prescribed physical therapy and a massage.  I have not gone to the massage because I can't find someone who takes my insurance. After I started seeing the Physical Therapist, she said my hips were not working appropriately. She gave me specialty exercises to strengthen my back, so I could get up and down. Around the end of September, I noticed that my hands were hurting a lot and I was having trouble with them. Then my feet started hurting; they were burning. I would not walk a lot. I went to see the Rheumatologist in October. He diagnosed my feet with Plantar Fasciitis. With my hands, he wants me to get an X-ray and put Voltaren 3 times a day to see if that doesn't help with the pain. He said he was going to do test for Lupus. My hands, feet, and hips are still hurting. My back is a little better.
Moderna COVID-19 Vaccine EUA Fast heartbeat that night when I went to bed. Before that I had little sharp pains in different areas of my body.   I could not sleep for 3 nights.  I was very tired, but just couldn't go to sleep.  After having those side effects, I do not want to take the second vaccine shot, which is due on April 9th.
HEADACHE WORSENED; This spontaneous report received from a patient via a company representative concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis, and other pre-existing medical conditions included: Patient did not report any relevant medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported. On an unspecified date, the patient experienced headache worsened. Laboratory data (dates unspecified) included: Blood test not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with adalimumab was withdrawn. The outcome of headache worsened was not reported. This report was non-serious.
Shot was given at yearly physical 3-22-18 at 3:30 PM, woke up 5:30 AM 3-23-18 with a fever of 101.5 swollen face with bright red cheeks and forehead, headache, sore upper body, nausea, dry mouth, light headed, teeth on left side of mouth hurt. Slept all day except to use the bathroom. Broke fever at 12:49 PM 3-23-18 (98.9).
Case number PHEH2013US013350, is an initial spontaneous report received from a physician on 18 Jun 2013: This case refers to a female patient of unspecified age. She received only Men A lyophilized conjugate component of MENVEO vaccine (batch number: A12118) reconstituted with sterile saline from the MMR vaccine (other manufacture), intramuscularly on 13 Jun 2013. She did not received Men C, Y. W-135 liquid conjugate component of MENVEO vaccine. No adverse reaction was reported following the administration error.
severe pain in the arm; Swollen lymph nodes in the clavicle; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Aug2021 15:00 (Lot number: FDOHPBC) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Thyroid" (unspecified if ongoing); "Cardiac Arrhythmia" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Covid" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: SYNTHROID. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 13Aug2021 07:00, outcome "not recovered", described as "severe pain in the arm"; LYMPHADENOPATHY (non-serious) with onset 13Aug2021 07:00, outcome "not recovered", described as "Swollen lymph nodes in the clavicle". Therapeutic measures were not taken as a result of pain in extremity, lymphadenopathy.  Additional information: No treatment received, no other vaccines within 4 weeks prior to the covid, no covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Initial and follow up information has been received from a pharmacist concerning her 11 year old male child, with no known allergies or pertinent medical history, who on 24-MAR-1997 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). There was no illness at the time of vaccination. Subsequently, in April 2005 the patient developed a mild case of chickenpox with approximately 7 pox behind his left ear, 4 on his upper left arm and 1 on his lower left forearm, previously reported as about 30 spots. The patient had a fever. In 2-3 days they scabbed over and he recovered. On 26-JUL-2007, the child developed another mild case of chickenpox with about 5 spots on his right pinky finger. The spots crusted over by 29-JUL-2007. Subsequently, the patient recovered. No further information was provided. There was no product quality complaint involved. Additional information is not expected.
Chills & fever for about 8 hours, tinnitus started a couple days later (severe in left ear, slight in right ear)
Had swelling of eyes, tearing and sneezing for 3 hours, post vax. Was seen ER and sent home. Follow-up done on 2/12/01. Was given Benadryl in ER.
patient stated she felt like her blood pressure was going up right after vaccine administration. I took her BP and it was 190/112. She got hot and then cold and shaky.  I got her some water and propped her feet up and took her blood pressure 3 or 4 more times over about 20 minutes then we decided to call 911.
Immediate heavy bleeding and extreme swelling, pain and tenderness.  Headache 30 min after receiving 1st dose, and has not faded 30 hrs later. Unable to lift arm all the way up and forward due to pain and tightness in arm. Twitching of muscles in same arm as injection . Administrator of injection said I was worst bleeder he has seen since day 1, and advised and ice pack for swelling. Pain and swelling in arm is tremendous.  Muscle of injection site is hard and very painful. OTC medications not helping with pain or swelling.  Reluctant to go for 2nd dose.
This spontaneous report has received from a pharmacist referring to a 72 years old female patient. The patient had none, medical history, concomitant therapy drug reactions or allergies. Information about concurrent condition was unknown. On 12-SEP-2018, the patient received a dose of PNEUMOVAX 23 (lot # N025656, expire date 19-APR-2019) intramuscularly for prophylaxis. On the same day, after receiving received vaccine 2 hours later, the patient couldn't lift arm with severe pain which persisted to 14-SEP-2018. The patient received no treatment. There was no lab diagnostic or study performed. The pharmacist reported that "she recommended that patient call physician and apply cold compress to injection site". The outcome of the event was not recovered. Causality assessment was not provided.
vomiting normal following the 2nd Covid vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting normal following the 2nd Covid vaccine) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VOMITING (vomiting normal following the 2nd Covid vaccine). At the time of the report, VOMITING (vomiting normal following the 2nd Covid vaccine) outcome was unknown.            No concomitant medication was reported.  Treatment information was not provided.
At approximately 10:20 (5-7 min post-vaccination) client c/o not feeling well and went to school nurse's office. Client was seen by the school nurse slumped over and seized for approximately 30 sec.  Client then vomited and felt dizzy/lightheaded, diaphoresis was noted. Client was laid on a cot and VS were taken - HR 82, RR 14, Temp 98.7, BP 110/62, 95% on RA. Client was quite pale and stated he had developed a HA (3/10 on pain scale). Client's parent was called and arrived 10-15 post-seizure. Parent stated only medical hx was surgical removal of subarachnoid cyst in July 2014, denied any food/drug allergies or previous reactions to vaccine. Client takes Vyvance qday for ADHD. Parent called pediatrician and neurologist. Both physicians declined to see the client as they felt the client was not in any danger and his reaction was not related to his current or previous medical history. Client's mother took him home after an additional 30-45 min of monitoring by the school nurse.
Received Rota vaccine on 8/7/14. That night started having frequent stools about 12 x/day. By 8/10/14 had visible blood in stools. 8/19/14 bloody stools resolved stool cultures sent.
Behavior change, severely tense, irritable, depressed, problem breathing, weakness, fast heart beat, muscle aches, hives. No treatment meds received. Conditions lasted 2 days.
Pt received two shots on Friday. She developed a rash at injection site, it is warm to the touch and very painful. She also has a head ache, fever, body aches and chills. Pts temp during visit was 98.7. I verbally discussed the symptoms with dr. and he agreed to evaluate the pt.   Dr. recommendation was to ice the area, rest, continue ibuprofen and drink water.
Mixed Series  - patient received 1st dose Pfizer.  Medical Record shows second dose Moderna.  CDC card documents 2nd dose Moderna Lot number.  Cannot validate which vaccine was given for dose 2, so have to assume it was a mixed series.  No negative outcomes or reactions reported.
Mom found pt febrile about 11PM pt was asleep for about 3 hrs mom gave APAP, pt started shaking all over turned pale, lips turned blue; pt caught breath, parent sponged w/alcohol & placed in tepid water; pt weak & limp for several minutes;
12 hrs post vaccine- runny nose, severe headache, arm tenderness, and generalized body aches 24 hrs post vaccine- sluggish and achy; headache has lessened, but still there; dizziness < 1min, 1 time; Tylenol Extra strength taken 12/23 830pm, 12/24 230am, and 12/24 8am
patient inadvertently received a dose of MENACTRA instead of the intended MEN B with no reported adverse event; Initial information received on 25-Apr-2022 regarding an unsolicited valid  non-serious case received from  other health professional.  This case involves a 16 years old female patient and it was reported that patient inadvertently received a dose of Menactra instead of the intended Men B with no reported adverse event,  while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 18-Apr-2017 she also received an unknown dose of the suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number and expiry date: not reported) with an unknown batch number in unknown administration site. On 11-Mar-2022, the patient received a  second dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE( lot number and expiry date:  not reported) via unknown route in unknown administration site. On 19-Apr-2022 she also received a  0.5 ml dose of the same vaccine  (lot number: UJ268AA ; expiry date: 02-Apr-2023) via intramuscular route in the left deltoid for immunization.  On 19-APR-2022 the patient had visit for second dose of Men B and  inadvertently received a dose of Menactra instead of the intended Men B with no reported adverse event (wrong product administered) 5 years 1 day following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event (patient inadvertently received a dose of MENACTRA instead of the intended MEN B with no reported adverse event).  Outcome: unknown  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 the 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.
red nodule forms in arm, itchy, then improves, skin gets hyperpigmented and nodule resolves. Then new nodule appears in different location on arm. the hyperpigmented areas remain and are itchy. All in right arm.
Cold sore 1 days following vaccine, mild swelling of lymph nodes on jaw and neck non-tender. severe lymphadenopathy of neck, tender beginning  on 1/20/21. General fatigue, feverish, and sore throat.   Antibiotics started on 1/23/21.  Decrease tenderness of lymph nodes on 1/24/21
I noticed after the last dose of HPV my daughter started to catch virus after virus. I kept getting the yearly FLUMIST to avoid the flu. In 2015 she came home with respiratory symptoms and a hive. The hives and respiratory stuff got worse. The doctor said she had bronchitis with hives. Few days later I had her in the ER she had trouble catching her breath. There they gave her a breathing treatment and steroids for hives. She never recovered. I repeatedly took her to the doctor and they tested her for mono and strep. Mono came back positive. But later found out it was false positive. Over a course of a month, she had headaches, dizziness, hives, sore throat, fatigue, pain and nausea. Then each joint would start to swell. Then she had severe allodynia in her knees along with all the symptoms I mentioned. Her symptoms keep getting worse. The pain affects her nerves as well, she can't stand in the shower because she has trouble regulating her body temp and she gets dizzy.
Loss of taste; Headache; Mild cough; Tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event). Concurrent medical conditions included Asthma.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced COVID-19 (Tested positive for COVID-19). At the time of the report, COVID-19 (Tested positive for COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, COVID-19: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on biological implausibility the event of COVID-19 infection is assessed as unlikely related to mRNA-1273.  Based on the current available information and temporal association between the use of the product and the start date of the events of headache, ageusia and cough, a causal relationship cannot be excluded
At day 8, my arm began feeling itchy and hot at the injection site.  The injection site began to become sore again and devoloped a red circular rash.
16 weeks pregnant; experienced nausea ~3 hours after injection and vomiting starting ~7 hours after injection
First day was arm pain, headache, achy feeling. Second day was swollen lymph nodes under arms, swollen injection site, migraine and tired to the point of exhaustion, dizzy. Third day was migraine, dizzy, nose bleed, exhausted, sleepy, rash started on neck then spread to face, chest and forearm, swollen eyes and throat, sores in mouth and on lips. Day 4 went to primary doctor. Day 5 and 6 rash starting to subside with prednisone, Benadryl.
Sore throat; itchy hives and tightness in chest. Referred to PCP.
PNEUMOVAX given IM Left deltoid on 2/18/09. On 2/19/09, pt returned to ofc with edema, pain and erythematous streaking from injection site down beneath axilla-streaking completely 1/2 way around his arm.
groin pain radiating around to me low back.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of GROIN PAIN (groin pain radiating around to me low back.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2020, the patient experienced GROIN PAIN (groin pain radiating around to me low back.). At the time of the report, GROIN PAIN (groin pain radiating around to me low back.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In January 2013, a healthcare provider at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In February 2013, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is considered to be not recovered. Additional information has been requested.
w/in 20 mins of vax pt face was red & blotchy; HIB site reddened, MMR site had small area reddened; BP 90/70, lungs clear, no wheezing hives on back, face, arms, chest;
Headache; Fever; soreness; fatigue; This is a spontaneous report from a non-contactable consumer or other non hcp. A 24-years-old male patient received second dose of BNT162B2 (COMIRNATY, formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration in Arm Left on Feb2021 (age at vaccination 24years old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took amoxicillin and experienced drug hypersensitivity. The patient had historical vaccine of BNT162B2 (CO-MIRNATY, formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration in Arm Left on Jan2021 11:00AM (age at vaccination 24years old) as single dose for covid-19 immunisation. Since the vaccination, the patient had not been tested positive for COVID-19. On unspecified date in Feb2021 the patient experienced headache, fever, soreness, fatigue. The patient did not receive any treatment for the adverse events. The clinical outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Rash was just noted the night before clinic visit, no fever, was complaining of itching, no other associated S/S.