chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lightheadedness; throat became scratchy; tongue felt thick; hives; itching; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: E-1284), intramuscular in the right arm on 12Jan2021 at 14:00 at a single dose for COVID-19 immunization. Medical history included hypothyroidism and allergy to IV contrast. The patient was not pregnant at the time of vaccination, had no other vaccine within four weeks, and did not have COVID prior to vaccination. Concomitant medication included levothyroxine sodium (SYNTHROID; reported as other medication within 2 weeks). On 12Jan2021, less than 5 minutes after administration (also reported as at 02:15PM), the patient experienced lightheadedness, throat became scratchy, tongue felt thick, hives, and itching. These were resolved with Benadryl, Pepcid, Zyrtec, and IM steroids (also reported as PO and IM medications). It was reported that the events resulted in a doctor or other healthcare professional office/clinic visit. The patient has not tested positive for COVID post vaccination. Outcome of the events was recovered/resolved (also reported as recovering).  Information on the lot/batch number has been requested.
about 36 hours after the injection, the patient complained of a sore arm at the injection site and then noticed a red swollen area a few inches below and towards the middle to inner side of the bicep on the injection site arm.  as of today 10-15-23, the red area is not swollen but was very itchy and slightly warm
At about 3 -4 am on the morning after the vaccine I went to the Bathroom to Urinate, upon rising I slumped to the floor and passed out. I also had sweating and profound weakness. I crawled back to the bedroom and was placed in bed with assistance. I also experience feverish ness, sweating, chills, insomnia, muscle aches, and nausea throughout the night. The next morning I am able to stand, eat, and walk. I still have a headache, muscle aches, and fatigue. It is now 1pm on 1/26.
Administration of a third dose of Shingrix; This case was reported by a consumer via interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional information was provided as follows: The age at vaccination was not reported. The patient received 3rd dose of Shingrix which led to extra dose administered.
Initial report received from a healthcare professional (Nurse) on 20 August 2012. A male patient, whose medical history was not reported; had received MENACTRA vaccine sanofi pasteur Inc. (batch number U4341AA, route, site of administration, dose, dose number were not reported) on 16 June 2012. The patient had concomitant medication of metacycline. On next day patient was out in the sun and got sunburned. The patient had lot of swelling (head and scalp) and got worse in his legs, some were swollen. Details of lab tests and treatment were not reported. The patient's outcome was not reported. Documents held by sender: None.
Fatigue, migraine, fever (102 F then 104 F), vomiting bile, nausea, diarrhea, body aches, mental confusion.   One episode of vomiting, and multiple episodes of diarrhea. Constant fatigue and fever, despite taking Tylenol as recommended by manufacturer. Mental confusion intermittent and worse when fever was higher.  All are better today (04/01/2021) except for the migraine.
I developed ED and still have it 3 weeks later.  Can you let me know if this is permanent? or temporary? Also, You should let other sexually active males of this risk.
Muscle cramps and weakness, cold/numbness/tingling bilateral upper extremities. Abnormal vaginal bleeding, prolonged menstrual cycle. Daily headaches. Near syncope twice.
This case was reported by a consumer and described the occurrence of spontaneous abortion in a 28-year-old female subject who was vaccinated with Flu vaccine (GlaxoSmithKline) while pregnant. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Flu vaccine (unknown). On 10 November 2007, at an unspecified time after vaccination with Flu vaccine, the subject experienced cramping and light vaginal spotting. An ultrasound performed on 14 November 2007 revealed no sign of pregnancy. HCG levels taken on 14 November 2007 were 168 and HCG levels taken on 16 November 2007 were 107. Heavy bleeding and passing of material began on 17 November 2007, concluding on 23 November 2007. The reporter referred to the events collectively as a spontaneous abortion beginning on 17 November 2007. This case was assessed as medically serious by manufacturer. The spontaneous abortion with heavy bleeding and passing of material resolved by 23 November 2007. Outcome of other reported symptoms was unspecified.
5 hrs after vaccination, employee noted redness and swelling at site; next day redness and swelling continued and began extending down towards elbow. Mild itching and warmth noted. 10/8/14 mild swelling noted below elbow and warm to touch.
Felt like throat was closing up, chills, sweating, pain in chest and arm, uncontrollable behavior, pain in back and headache.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Concurrent conditions and medical history were not reported. On 18-OCT-2015, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (the pharmacist did not know which of the following lots was administered to the patient: L025001, expiration date 06-OCT-2016; L012476, expiration date 10-JUL-2016; L026414, expiration date 15-OCT-2016) (strength, dose and route were not provided). Concomitant medication was not reported. No adverse effect reported. Additional information has been requested.
Client got her Pfizer booster around 3 pm on 1.17.22. Around 5 pm the same day, she started to feel tired and had body aches and went to bed early that night. She woke up 1.18.22 and felt usual and went to work. By 10:00 am she started to chill and went home. By 11:00 am, her temp was 102.2 and her hands, legs, and feet felt like they had frostbite and were tingling like hundreds of needles in those areas. This lasted several hours. Client states she "stayed on top of taking Tylenol, drank lost of fluids, and rested. Fever did not break until 4 pm" and she started to feel better around 6 pm on the 18th. On 1.19.22, client felt mostly recovered but noticed a large, swollen, painful lymph node under her left arm which was the side of her booster injection. Client continued to drink lots of water she states that day. She also got 2 lymph massages over the next few days which she feels were helpful. She feels the lymph node was back to being normal size and non-tender by 1.24.22.
Shortly after getting MenB and MCV4, patient felt dizzy and nauseous. Did not eat this morning, given juice and observed in clinic until symptoms resolved. Normal vital signs BP: 108/76, HR: 88, RR: 20, SPO2: 98%, Blood Sugar 98.
Starting 12/12/14 at 9 PM patient reports having shakes, chills, and possible fever. Lasted until 12/13/14 at 4 AM.
I had some arm pain and fatigue the day I received the shot, but was fine the next day. Seven days after the shot, however, the arm pain returned, with a rash that is raised and itchy. Additionally, I have pain on that side in my neck and armpit, and also waves of nausea. I have been running a low grade fever off and on over the last day or so, and feel fatigued.
Patient not able to raise arm above 90 degrees since receiving the vaccine. No numbness. Painful.
Intense hunger pains; Fatigue; Headache; Joint pain; Localized first finger joint stiffness and pain; Localized first finger joint stiffness and pain; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 05May2021 at 13:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within 2 weeks prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 14Apr2021 at 13:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. On 06May2021 at 09:00, 2nd day, the patient experienced joint pain. On 07May2021, 3rd day, the patient experienced fatigue, headache and intense hunger pains. On an unknown date in May2021, the patient experienced localized first finger joint stiffness and pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events joint pain on 2nd day, fatigue, headache, intense hunger pains on 3rd day, localized first finger joint stiffness and pain and treatment included Tylenol severe cold and flu. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events joint pain, intense hunger pains, fatigue, headache, localized first finger joint stiffness and pain were resolving at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax & 3 hrs later mom unable to wake baby; referred to PMD, awakened spontaneously soon, PMD called, no problems observed;
No adverse effects reported; Nurse reports a third dose of MMR II (R03160, 11/1/2020) was administered to a patient 14 years after second dose; Information has been received from a nurse, referring to a patient of unknown age or gender. Information of concurrent condition, medical history and concomitant therapy was not provided.       On an unknown date in 2005, the patient was vaccinated with the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (dose, strength, route, lot# and expiration date were unknown) for prophylaxis. On 24-JUN-2019 (also reported as 14 years after second dose), the patient was vaccinated with the third dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (dose, strength and route were unknown; lot# was reported as R03160 and expiration date 01-NOV-2020) for prophylaxis (inappropriate schedule of product administration). No adverse effects reported.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M023169 with an expiration date: 13-JUN-2018 (dose, frequency and route of administration were not reported). Administered dose of GARDASIL 9 experienced temperature excursion of 48.4 degree Fahrenheit for 35 minutes, 48.9 degree Fahrenheit for 35 minutes, 46.2 degree Fahrenheit for 5 minutes on an unknown dates and back in range. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. Additional information is not expected as the reporter did not wish to be contacted.
This spontaneous case reported by a patient, describes the occurrence of pain in extremity (pain in the left arm) and pyrexia (a little bit of fever) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 039B21A and 039C21A) for COVID-19 immunization. No medical history reported. On Apr 23, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jun 14, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 23, 2021, patient experienced pain in extremity (pain in the left arm) and pyrexia (a little bit of fever). Patient treated with Tylenol (paracetamol); unspecified dose and frequency. At the time of the report, pain in extremity (pain in the left arm) and pyrexia (a little bit of fever) outcome: unknown. Concomitant product use not provided. Patient did not receive any treatment after first dose of vaccine until second dose administration. This case linked to MOD-2021-225658 (patient link).
flublok quad was accidentally given to 2 patients under the age of 18, with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2022SA418789(CLUSTER).  This case involves a 16 years old female patient to whom influenza quadrivalent recombinant vaccine [flublok] was accidentally given under the age of 18 with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 10-Oct-2022, the patient under the age of 18 received a dose of 1 DF (dosage form) total of standard suspect influenza quadrivalent recombinant vaccine with no reported adverse event (product administered to patient of inappropriate age) with an unknown formulation (lot UJ 887AA, expiry date- 09-Jun-2023) via intramuscular route in the left deltoid for immunization. (latency: same day)  Action taken: not applicable.  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.
JOINT PAIN WITH FLEXION- INCREASED ON LEFT ELBOW; HEADACHE; FATIGUE; INJECTION SITE SWELLING; PAIN IN ARMPIT (LYMPH NODE); This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced pain in armpit. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced injection site swelling. On 11-APR-2021, the subject experienced joint pain with flexion- increased on left elbow. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from injection site swelling, and joint pain with flexion- increased on left elbow, and the outcome of headache, fatigue and pain in armpit was not reported. This report was non-serious.
Administered after frozen.; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 2-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 24R9R, expiry date 14th May 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd November 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse given Pediarix after being frozen at minus 0.45 Celsius for 15 minutes to the patient, which led to incorrect storage of drug. The reporter consented to follow up. This case was 1 of 10 linked cases, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021230186:same reporter US-GLAXOSMITHKLINE-US2021230181:same reporter US-GLAXOSMITHKLINE-US2021230191:same reporter US-GLAXOSMITHKLINE-US2021230173:same reporter US-GLAXOSMITHKLINE-US2021230195:same reporter US-GLAXOSMITHKLINE-US2021230178:same reporter US-GLAXOSMITHKLINE-US2021230188:same reporter US-GLAXOSMITHKLINE-US2021230180:same reporter US-GLAXOSMITHKLINE-US2021AMR231962:same reporter US-GLAXOSMITHKLINE-US2021230177:same reporter
NEUROPATHY 12/1/2021 NONTRAUMATIC ACUTE KIDNEY INJURY ACUTE RESPIRATORY FAILURE 9/10/2022 NONTRAUMATIC ACUTE KIDNEY INJURY ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/1/2022 NONTRAUMATIC ACUTE KIDNEY INJURY HYPOXIA 9/9/2022 NONTRAUMATIC ACUTE KIDNEY INJURY NEUROPATHY 12/1/2021 DM 2 W RENAL MANIFESTATION ACUTE RESPIRATORY FAILURE 9/10/2022 DM 2 W RENAL MANIFESTATION ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/1/2022 DM 2 W RENAL MANIFESTATION HYPOXIA 9/9/2022 DM 2 W RENAL MANIFESTATIONNEUROPATHY 12/1/2021 ACUTE RESPIRATORY FAILURE ACUTE RESPIRATORY FAILURE 9/10/2022 ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/1/2022 ACUTE RESPIRATORY FAILURE HYPOXIA 9/9/2022 ACUTE RESPIRATORY FAILURE NEUROPATHY 12/1/2021 HTN (HYPERTENSION) ACUTE RESPIRATORY FAILURE 9/10/2022 HTN (HYPERTENSION) ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/1/2022 HTN (HYPERTENSION) HYPOXIA 9/9/2022 HTN (HYPERTENSION)
Lymph nodes in pits of both arms swelled up to the size of golf balls within 12 hours of receiving the booster shot.  The lymph nodes eventually returned to normal in about 10 days.
Narrative:  COVID infections following completion of COVID vaccine series 03/23/21 COVID vaccine dose #1 04/23/21 COVID vaccine dose #2 07/13/21 Pt reports loss of taste and smell, body aches, headache, runny nose, sinus drainage and dry cough; reveals he was exposed to 6 family members who have had COVID since 7/2/21 07/14/21 Pt reports chills, body aches, fever, sore throat, loss of taste, temp 100.2 07/15/21 COVID test performed at pharmacy 07/20/21 COVID test performed at Hospital; COVID POSITIVE 07/23/21 Pt presents to ED reporting of increased shortness of breath while other symptoms are "getting better"; denies headache, CP, nausea, vomiting or coughing; pt admitted for COVID viral pneumonia 07/24/21 Pt discharge with rx for albuterol, ascorbic acid, budesonide, cholecalciferol, dextromethorphan/guaifenesin, melatonin, omeprazole, prednisone, zinc 07/25/21 Pt reports hiccups with no COVID symptoms 07/26/21 Pt reports cough, denies chest pain, SOB, fever 07/27/21 Pt reports dry cough, fatigue but is feeling better; severe hiccups, denies fever 07/29/21 Pt is improving and quarantine ended
Had a dull ache in arm / Pretty bad pain from arm down to wrist /ittle to mild muscle pain/ Hand pain; upper back pain; knot in their upper back,shoulder and base of skull; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Had a dull ache in arm / Pretty bad pain from arm down to wrist /ittle to mild muscle pain/ Hand pain), BACK PAIN (upper back pain) and MASS (knot in their upper back,shoulder and base of skull) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 044A21A) for COVID-19 vaccination.     Concomitant products included MELOXICAM for an unknown indication.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-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, the patient experienced MYALGIA (Had a dull ache in arm / Pretty bad pain from arm down to wrist /ittle to mild muscle pain/ Hand pain), BACK PAIN (upper back pain) and MASS (knot in their upper back,shoulder and base of skull). The patient was treated with CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, MYALGIA (Had a dull ache in arm / Pretty bad pain from arm down to wrist /ittle to mild muscle pain/ Hand pain) had not resolved and BACK PAIN (upper back pain) and MASS (knot in their upper back,shoulder and base of skull) had resolved.            Treatment includes warm bath and massage.
This was patient's second dose. Patient reported after first dose she felt mild dizziness, but no loss of consciousness. After 2nd shot on 5-20-21 patient complained of dizziness. Patient sat in chair for observation after immunization for 30 minutes until medical team was called and took patient to observation room. Symptoms included dizziness and heart rate >100.
The patient was vaccinated in the Am in right arm. She noted soreness after receiving her vaccination. That evening her right arm was extremely sore and she noticed a 3 in. in diameter raised purplish, black bruise over the vaccination site. Over the next few days, the hematoma/ bruise grew to 5 in. in diameter. She reported having significant pain in lifting her right arm. The problem took over weeks to resolve.
Systemic: Hyperventilation-Medium, Systemic: Tachycardia-Medium
Patient with a history of bakers yeast allergy dignosis as a kid ten years ago (2011) that later stopped in a couple of months of that same year with treatment and diet. In a couple of months (2011) returned to normal diet and without treatment. Not any recurrence of any symptoms in 10 years, until June 25th, 2021 (26 days after the first dose of Covid 19 Vaccine) that the same allergy appeared with the same symptoms as in 2011 consisting of: Sections of irritated red, rised and swollen skin (from less than 1 inch to 5,6 or 7 inch diameter) in head, face, back of ears, arms, torso, pelvis and legs. On and off episodes, still ocurring as this moment (July 30th).