chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt vaccinated with Meruvax II developed sore & swollen glands, a slight fever & a feeling of tiredness. Developed palpable but invisible rash. Experienced headache which lasted until the following day, swelling of the fingers & hand joints.
fever; joint pain; headache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. Medical history included gout and osteoarthritis. Concomitant medications included indomethacin [indometacin] and colchicine. The patient got the first dose of the covid vaccine and has developed fever, joint pain and headache. The patient has gout and osteoarthritis and she take indomethacin and colchicine however she has not taking those medications lately and she mentioned that she usually gets joint pain from her osteoarthritis. She went to her primary doctor and to the hospital and no one wanted to attend her since she has fever. She would like to know which medication she can take for her fever. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot number cannot be obtained. No further information is expected.
I was at a conference last week and caught Covid-19 while there between 07/02/2022 and 07/08/222. Symptoms began on 07/09/2022 with a scratchy throat, muscle aches around 07:00PM. It just went down hill from there, by Sunday I was having difficulty breathing and a lot of congestion, headache, the roots of my teeth were throbbing, and I was salivating uncontrollably, and it would not stop, it was a very difficult, from the neck up. I was a respiratory therapist for 20 years and it was scary as I laid in bed one night and it felt like my air was blocked off. I felt like I was developing diphtheria. I was sleeping and I would wake up gasping for air. Monday morning, I called the doctor, and they scheduled a tele-visit Tuesday morning and they prescribed PAXLOVID and benzonatate and recommended MOTRIN and alternate with TYLENOL and take DAYQUIL and NYQUIL. Currently symptoms are ok, but I cannot talk well, I get very winded talking than anything else, I slept well last night. Congestion is still here and if I cough it feels like my head is going to pop off. The doctor said to go to hospital if I get a fever or oxygen stats go down.
Arm extremely painful - site hard and red for weeks; several weeks of diarrhea, some skin break out in almost pimple-like spots on face, nausea
Patient is under 10 year old and received the Pfizer which is only authorized for 12 year and older
Kinrix given to a 15 months old patient; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-month-old male patient who received DTPa-IPV (Kinrix) (batch number T24G7, expiry date 4th June 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th September 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 17th September 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter reported a kinrix maladministration as a 15 months old patient was administered with the vaccine, which led to inappropriate age at vaccine administration. The Prescribing information described that Kinrix was approved for patients between 4 to 6 years old. The reporter consented to follow up.
Patient experienced "stiffness" in her left arm and a "weird feeling" about 4:30 pm the afternoon of her administered vaccine. Later at 6:30 pm, Patient reported "chills, fever of 102 degrees F, and body ache." Patient also reported having dry mouth and excess urination.
Developed urticarial rash, generalized, within several hours, post vax. Other symptoms were irritability and 1 episode of emesis. Treatment: Benadryl syrup.
Patient reports that the area around the injection site began to swell. Her arm also became red circumferentially.
widespread muscle fasciculations 2 days p/vax has persisted for 2wk;
The pt experienced swelling of soft tissues around eyes, was irritable and mild urticaria rash.
Patient reports nodule/knot at injection site that has not gone away. Per patient, doctor told her this was due to vaccine being injected too deep.
Brain fog; movement disorder; Could not walk; Autoimmune Disease; The patient experienced Postural Orthostatic Tachycardia Syndrome ("POTS") and Autonomic Dysfunction; The patient experienced Postural Orthostatic Tachycardia Syndrome ("POTS") and Autonomic Dysfunction; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a 13-years-old female patient. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On 21-JUN-2017, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (Lot #, expiration date, dose, route of administration and anatomical location of vaccine were not provided) for preventing cervical cancer.  In 2017, the mother noted manifestation of symptoms consistent with injury of autonomic dysfunction. As the months progressed, so did the injuries. She was seen by multiple physicians and specialists for her complaints which now included: Postural Orthostatic Tachycardia Syndrome ("POTS"), paralysis, neurological disorders, movement disorders, brain fog, and is unable to focus her eyes. Plaintiff has uncontrollable tremors during which she has little to no control over her movement. Her symptoms of POTS include seizures, fatigue, fainting, paralysis, blurred vision, chronic nausea, and headache. Plaintiff could not walk for a period. Additionally, based upon her chronic and severe post-Gardasil symptoms, Plaintiff had been diagnosed with various medical conditions, including, but not limited to, POTS and autonomic dysfunction.  The reporter considered the events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL).  Upon internal review the event of Autoimmune Disease was considered as medically significant.
Rash on arm. Very itchy. Very uncomfortable. Shortness of breath, feeling ill. Trouble sleeping.
I received my 4th dose of Moderna Bivalent on 11/2022. My adverse event started on 11/21/2022 in the evening. I felt like something rushes me. I felt like I was drugged. I felt chills, body aches, and low energy. I had aches from hip to ankle. 2 weeks ago I felt a tight feeling in my chest. I took ADVIL to over come the symptoms which helped with the body aches. It was making me cough but the cough wasn't really there. It's different than the asthma. I even took albuterol but it didn't help. I jet felt the tightness in my chest. It happened 4 times all together with the same symptoms but this time I felt tightness in my chest along with other symptoms. First time it happened on November 21/2022. The second time it happened on December 26/2022. The third time it happened on January 16/2023. The  fourth time it happened on Feb 1/2023. This is something new. It happens every 3-4 weeks. I spoke with my doctor on December about this. In mid October I was diagnosed with Shingles and my doctor prescribed me with some medications to take. When my daughter was diagnosed with Flu my doctor then prescribed me TAMIFLU to prevent Flu. I still have the chest tightness as of today 02/10/20223.
I experienced brain fog, muscle weakness, muscle giving out randomly, dry mouth, lethargic, high blood sugar and potassium, and falls due to weak muscles and needing to go to a skilled nursing facility.
Shortly after receiving the vaccine, she began to complain of dizziness. she began to shiver. denied SOB; soon had reflexive repetitive cough; Bilateral anterior breath sounds clear on auscultation; Color WNL; c/o dizziness again; reclined seat and patient awareness and LOC decreased for a few seconds; c/o feeling weak; B/P120/82; O2 sat 95%-98% on room air; Skin warm and dry; After approx 30 minutes patient became more alert and coughing decreased; Patient stated feeling better and insisted on going home and no emergency services. Followed up with spouse approximately 1.5 hours later who stated patient was feeling better.  4/30 follow up spouse stated patient had low grade temp and body aches; Spouse plans on taking patient to HCP for follow up.  Will keep Health Services informed.
This spontaneous report as received from a nurse refers to a 11 years old patient (unknown gender). No concurrent condition, medical history or allergy/drug reactions were reported. On 13-APR-2015, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, dose number 1, lot # K004204, exp. date: 12-JAN-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Mom stated right thigh is swollen, tender and pt has fever of 103 degrees. DTaP given 7/25/03 in RAT. Pt is able to ambulate although she is complaining of discomfort per Mom. Mom is giving Motrin every 6 hours, cold compresses to site.
Chills; Fever; This is a spontaneous report from a contactable consumer via Pfizer sponsored Program.  A 53-year-old male patient received second dose of received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Feb2021 at single dose for COVID-19 immunisation at the age of 53-year-old.Medical history was none. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date for COVID-19 immunisation. On 06feb2021, the patient experienced chills and fever; the patient was not treated for the events. The outcome of the events was unknown.  Follow-up attempts completed. information about batch/lot number cannot be obtained. No further information expected.
had unusual, high pitched cry, screaming for hrs, on & off x several days, eyes glazed, fever (to touch, not measured), inc startle react approx 4 wks startle to normal noise, reacted more 4-5 wks;
Narrative: Moderna bivalent booster 10/5/2022 at the clinic, patient was given half a dose of the vaccine which is 0.25 ml instead of 0.5 ml.
induration at injection site; dizziness; episode of "all over" itching; redness at site of injection; swelling at site of injection; This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st August 2020, the patient received the 1st dose of Shingrix. On 1st September 2020, 1 days after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On an unknown date, the patient experienced injection site induration, dizziness and generalized pruritus. On an unknown date, the outcome of the injection site erythema and injection site swelling were not recovered/not resolved and the outcome of the injection site induration, dizziness and generalized pruritus were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site induration, dizziness and generalized pruritus to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced redness and swelling at site of injection. The HCP also reported that the patient experienced induration at injection site, dizziness and an episode of all over itching.  None of the effects lasted for very long. The reporter consented to follow up and no batch number and expiration date was provided.
patient was administered the diluent without reconstituting it with the Hib (Pentacel Vaccine); Initial information received on 05-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 months old male patient who received the diluent without reconstituting it with the HIB of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE [PENTACEL] lot UJ100AA, expiry date: 13-Jun-2020, via unknown route in the left vastus lateralis on 05-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation.  It was a case of actual medication error due to inappropriate reconstitution technique.  It was not reported if the patient experienced any adverse event was occurred.   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.  Documents held by sender: none.
swelling @ point of inject (lt thigh) & down to/including lt knee; swelling in knee dec some, but not fully; pt could not fully straighten leg; seen by MD; pt had arthritis;
This 70 year old female received the Covid shot on 3/17/21 and died on 5/1/21.
Case number PHEH2011US00892 is an initial spontaneous report received from a health care professional on 01 Aug 2011. This report refers to an 11 years old male patient. He was given only the CYW-135 liquid component of MENVEO intramuscularly on 29 Jul 2011. No other adverse reaction was reported.
pt recv vax & devel chin & upper lip numbness, lt eye twitch & blurry vision on 25OCT96;14 days p/vax dx w/Bells palsy 25OCT96;pt has not recovered;
Information has been received from a registered nurse concerning a 11 year old female with a history of hospitalization in 2005 due to convulsion who on 12-AUG-2008 was vaccinated at 16:30 with a first dose of GARDASIL (lot # 658556/1060U), 0.5 mL, IM, into the left deltoid. At the same visit, the patient also received ADACEL and MENACTRA into the right deltoid. On 12-AUG-2008, after getting her first dose of GARDASIL, the patient experienced a petit mal seizure lasted for about 15 seconds. No lab tests were performed. The patient recovered at the office and was released. Upon internal review, petit mal seizure was determined to be an other medical event. Additional information has been requested.
States lightheadedness, feeling flushed, stomach queasy, BP 125/75. Lungs clear bilat, no stridor noted, denies itching, SOB, no local reaction noted at site. States have not eaten all day. Instructed to eat. After eating prolen bar feels better. Instructed to go to ER if symptoms worsen. No changes after eating observed for 20 mins.
1st does: headache, sore arm for about 4 days, swollen lymph nodes in neck on side on injection 2nd dose: body aches without fever, swollen/painful lymph nodes in neck on side of injection, fatigue
This patient developed diffuse rash (varicella) all over her body. She required symptomatic treatment.
On 11/28/2022, I started to experience symptoms of fatigue. I took a nap and when I woke up I had a headache and started with a cough. The next day, my symptoms seemed a bit worse, so I performed a home test for Covid-19 and it came back positive. I reached out to my PCP on 11/29/2022 and he prescribed LAGEVRIO and prednisone for me to take. I feel that the medication helped with my symptoms. Overall, it felt like a bad cold. Everything went away, but the fatigue and a lingering cough. On 12/11/2022, I finished out of the shower and noticed that I was very lightheaded. I wasn't even able to make it from the bathroom to the bedroom. I notice that I am still having dizzy spells and I have a lingering cough that comes and goes. I have not gone to the doctor for the dizziness yet. On, 12/24/2022, my left leg, from the knee down, started to swell. I saw my doctor on 12/29/2022, and he sent me for a doppler scan. The swelling has gone away and we are not sure what happened. I also had an episode on 12/30/2022 where the right part of my upper lip started to swell. When I woke up the next day it had turned into a fever blister, which is something I have never had in my lifetime. It is still there today.
Patient reports pain at area of injection initiating after vaccine was given on 10/23/2020. Patient is still reporting pain on 12/3/2020, stating it has radiated down arm to forearm as well as shoulder. Patient has seen his primary care provider who informed him it was some sort of allergic or adverse reaction at the sight of injection. Patient denies any other adverse effects including fever, shortness of breath, swelling or redness at sight of injection. Area does not appear to be infected. Pain is unrelieved with OTC analgesic use such as Aleve.
Erythema and induration at injection site. Concerning for infection vs local immune reaction. Treating with doxycycline and anti-inflammatories.
Lot # 053E21A was administered outside the 30-day Use by Date.   "The vaccine administered maintained the activity necessary to protect against the SARS-CoV-2 (Covid-19) virus at time of administration."
My son had fever 99.1 degree last night after received the flu shot.  I gave him Tylenol around 9pm.  In the midnight, he developed fever again.  I gave him Motrin around 2am this morning.  This morning, he still had low-grade fever around 99.  I have reported this adverse event to his doctor's office this morning.
Patient reported experiencing unusual warming sensation from head to toe.  Patient  also reported disoriented feeling and anxiety.  Vital signs were normal and EMS cleared patient.
Information has been received from a female who on 19-SEP-2012 was vaccinated with Zoster Vaccine Live. The patient mentioned that she experienced a lot of pain underneath her left breast that went all the way to her back. The patient mentioned that on 20-SEP-2012, the doctor diagnosed her with costochondritis. The patient sought medical attention and had an MRI (results not specified). The patient wanted to know if this was what Zoster Vaccine Live may have caused.
Provider stated patient had anaphylaxis (facial swelling) at around 2:16, 1 dose epi pen was administered and rapid response called.  Patient was transported to the ed .  Per providers note,  developed sensation of  Facial swelling, lip swelling, tongue swelling and difficulty breathing
received his third dose/booster dose of the Pfizer COVID 19 vaccine on 16Aug2021; received his third dose/booster dose of the Pfizer COVID 19 vaccine on 16Aug2021; achiness; metallic taste in his mouth; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on 16Aug2021 as dose 3, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Previously the patient received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown) on an unspecified date for COVID-19 immunization. It was reported that a 48 year male "received his third dose/booster dose of the Pfizer COVID 19 vaccine on 16Aug2021" and since then had "achiness, which has gone away", but "still has a metallic taste in his mouth". The patient had not seen this listed as a common side effect. He was wondering if this had been reported. "Because it is not getting any better". The outcome of the event achiness was reported as resolved on an unspecified date in 2021. The outcome of the event "metallic taste in his mouth" was reported as not resolved.  Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.
I woke in the middle of the night to pain all over my body, from the top of my head to the bottom of my feet. My joints and muscles hurt. Severe pain in back, neck and hips. Major headache. Then I started having chills and took some ibuprofen at around 6:45 am then I broke out in a sweat and felt like I was in fire. I?m very tired and fluctuating between hot and cold. Also have pain at site of shot, but no worse than with flu shot. I also seemed to be having a little bit of rapid heartbeat earlier.
headache; This is a spontaneous report from a contactable consumer (patient's husband) via a Pfizer-sponsored program . This consumer reported the same events for two patients. This is the second of two reports. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 23Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient took 6-8 pills of TYLENOL after receiving the vaccine because she was having a headache on Jan2021. Outcome of the event was unknown.  Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021092403 same reporter/drug/AE, different patient
Information has been received from a pharmacist concerning to a patient (age and gender not reported). No medical history nor concurrent conditions were reported. 14-FEB-2019, the patient was inadvertently vaccinated with an expired dose of M-M-R II (Lot No. R002930, expiration date 30-JAN-2019) (rHA) for prophylaxis. Concomitant therapies included sterile diluent (manufacturer unknown). No adverse event was reported. This report was considered as non-valid since there were no patient identifiers.
2nd dose not received,Missed the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (2nd dose not received,Missed the 2nd dose) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose not received,Missed the 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (2nd dose not received,Missed the 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  No treatment medications were provided by the reporter.  Patient was scheduled to 2nd dose on 1-APR-2021 however somehow missed it and wanted to know if patient could get 2nd shot or does need to start over again.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow up received on 16-06-2021 and additional non-significant information added as reporter address