chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Female states she received the Moderna COVID vaccine on 1/21/2021, injection site:  LA. Lot# unable to be seen, d/t previous consent form not viewable only 2nd dose consent viewable. States the first dose administered 1/21/2021 to her left arm and later that evening she started experiencing inj. site pain, chills and nausea.  Symptoms continued through to Saturday 1/22/2021 with addition of a headache, w/ inj site pain, chills and nausea. On Sunday 1/23/2021, symptoms continued with addition of worsening headache, jaw locking and left side facial tingling. Referred to immediate in person medical care per symptom guidelines. Caller verbalized understanding.
On 1MAY92 mom reported that pt was having spells of staring, hyporesponsiveness every morning since 17APR92 lasting 8-10 sec-no convuls, never passed out, conscious but cant get up, labored breathing;
PATIENT RECEIVED THEIR SECOND DOSE OF MODERNA COVID-19 VACCINE 23 DAYS AFTER THEIR FIRST DOSE INSTEAD OF THE MINIMUM OF 24 DAYS AFTER FIRST DOSE. NO ADVERSE HEALTH REACTIONS ARE KNOWN TO BE ASSOCIATED WITH THIS ADMINISTRATION ERROR IN THIS PATIENT.
Pt stated that he local pain and irritation at injection site on 9/9/17 along with fatigue and malaise. On 9/10/17 he noticed that the right arm began to swell and had turned red from shoulder to elbow. He contacted his physician who suggested he start prednisone 5 mg daily and monitor progress. I looked at his arm today (9/12/17) and saw that it is still red and swollen but he states that it has decreased in severity over the past couple of days.
I don't know if it's related, but had severe pain in left arm, wrist, and middle& ring fingers.  It was like a severe cramp.  I could not make a fist and lost most of my strength for about 4 days.  I just woke up with the pain, I did nothing strenuous the night before.  It is 80% but still hurts.
Severe bone and muscle pain, headache, muscle weakness. Chills and fever with diaphoresis, eye blurriness.
This spontaneous report as received from a physician referring to a 13 year old patient of unknown gender. On 05-NOV-2015 the patient was vaccinated with GARDASIL 9 (dose was not reported, lot # L011846 with expiration date: 16-JUN-2017, intramuscularly in the gluteal muscle). The patient had not experienced an adverse effect. Additional information has been requested.
Information has been received from a RN concerning an adult pt with an unk medical history and unk drug reactions/allergies, who over the last ten days in Oct 2005, was vaccinated IM with a 0.5mL dose pneumococcal 23v polysaccharide vaccine (lot unk). Subsequently, in Oct 2005 the pt developed a local reaction at the injection site including soreness, warmth, erythema and swelling. Unspecified medical attention was sought. The pt was reported to be recovering. No product quality complaint was involved. Additional information has been requested.
has a little bit or arm pain and back pain on the side that she received the vaccine; has a little bit or arm pain and back pain on the side that she received the vaccine; This is a spontaneous report from a non-contactable consumer (caregiver). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration in arm, on an unspecified date, at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient recently received the vaccine and had a little bit of arm pain and back pain on the side that she received the vaccine on an unspecified date. The reported asked if this was normal and asked if the patient can use acetaminophen to treat pain and some warm compress. The outcome of the events was unknown.  No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.
Swelling, redness, pain at injection site began on 8/11/2020. Patient had limited movement of his left arm. He presented to the office on 8/13/2020 for evaluation. Physician evaluated the site and diagnosed him with bursitis.
15MAR96 1130PM to hosp ER for t103.4, pulse 160, very irritable;no vomiting, no diarrhea; released w/amoxicillin
BONE PAIN; FEVER; HEADACHE; NAUSEA; MUSCLE PAIN; 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: Unknown) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced bone pain, fever, headache, nausea, and muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, headache, bone pain, nausea and muscle pain was not reported. This report was non-serious. This case, from the same reporter is linked to 20210428556.
I got red spots on the inside of both elbows 3-4 days after the vaccine. I received the vaccine on 4/7/2021. This is starting to  clear up. On 4/19/21 I noticed I have a large swollen spot on the right side of my neck. I am currently taking antibiotics to see if it is a bacterial infection. The doctor and pharmacist think this could be a swollen lymph node after getting the Covid vaccine.
Patient has received flu vaccine yearly.  The evening of the vaccine the patient complained of arm pain (the arm the vaccine was given).  The next morning at school the patient was seen by the school nurse due to arm pain and had a 2 x 2 cm area of redness and swelling of skin around the injection site.  In the office approximately four hours later the patient had a local reaction that was 3x 3 cm.   This appears to be a local reaction to the vaccine.  Since it is the beginning of flu vaccine season I am reporting in case this became an issue with this product or lot number.
Changes in personality /behavior--mom showed several video clips before and after (probably 10-15minutes ) prior to vaccine--happy and talkative child.  After the vaccine--staring into space, not interactive, not verbal, respond to mom with whimper.  By the next day, mom reported some improvement. Offered office visit that afternoon but mom cancelled the appointment and came in the next morning on 7/21.  During the office visit, she had a normal neurologic exam. Per mom, she was much improved. She was interacting with her twin brother and playing on an electronic device during the visit. her mental status exam was normal. she answered questions appropriately. She was not as animated and happy as she was on the video prior to the vaccine.
Large welt from injection site. Increasing pain in arm that received the vaccine. It began as just around the actual injection site. It has been 9 days and the pain has slowly increased and now aches from the injection site, my entire bicep muscle,  and just below my elbow
Extreme day eyes - blurred vision. At the same time got extremely hot and my heart was racing. Lasted about a minute. Happened about 9:30 PM.
Pt devel erythema & edema @ the inject site immed p/recvd DT (peds)/OPV;
sinus congestion; tested positive for Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for Covid-19) and SINUS CONGESTION (sinus congestion) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for Covid-19). On an unknown date, the patient experienced SINUS CONGESTION (sinus congestion). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for Covid-19) and SINUS CONGESTION (sinus congestion) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. Treatment medication was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Follow-up received  and  patient denied consent to Follow-up.
vomiting, diarrhea & malaise are reported in a pt who recvd 1 dose of fluogen; above sx occurred w/in 24-48 hrs of vax; pt has recovered from above sx;
Patient received PNEUMOVAX 23 and 8 days later still cannot lift arm. MD diagnosed paralysis. patient is slightly improving but still debilitated.
Customer came in on 10-29-10 at around 10am to pick up some medication and mentioned that he developed a pain in his shoulder after injection. He said his physician also told him it was nerve pain, and prescribed CELEBREX.
unable to lift leg; pain in the back of the right knee; Chills; throbbing in the head; Fatigue; insatiable thirst; "no energy"; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of THIRST (insatiable thirst), ASTHENIA ("no energy"), LIMB DISCOMFORT (unable to lift leg), PAIN IN EXTREMITY (Sore arm) and ARTHRALGIA (pain in the back of the right knee) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 28-Feb-2021, the patient experienced THIRST (insatiable thirst), ASTHENIA ("no energy") and FATIGUE (Fatigue). On 02-Mar-2021, the patient experienced LIMB DISCOMFORT (unable to lift leg), ARTHRALGIA (pain in the back of the right knee), CHILLS (Chills) and HEADACHE (throbbing in the head). At the time of the report, THIRST (insatiable thirst), ASTHENIA ("no energy"), LIMB DISCOMFORT (unable to lift leg), PAIN IN EXTREMITY (Sore arm), ARTHRALGIA (pain in the back of the right knee), CHILLS (Chills), HEADACHE (throbbing in the head) and FATIGUE (Fatigue) outcome was unknown.            Reporter did not allow further contact
11:44 am Pt reported "neck stiffness" on the right side. Pt was evaluated by EMT's and released at 12:03pm.
1-2 weeks after receiving MMR (mid Aug), whenever child ingested eggs or milk in any form, 5-10 hrs after ingestion develops itching, dry and cracked skin crying and is usually up all no. fussy. These symptoms subsided when milk and egg removed from diet and returned whenever ingests them. Had no problems with these foods prior to receiving MMR.
Toe Patient's left arm is red; The VARIVAX was inadvertently reconstituted with VAQTA and administered together subcutaneously to a 1 year old in her left arm.; This spontaneous report was received from a medical assistant and refers to a 1-year-old female patient. Her concurrent conditions included ear infection. Concomitant therapies included antibiotics. No information regarding the patient's pertinent medical history and drug reactions or allergies was provided.  On 13-AUG-2019, the patient inadvertently received varicella virus vaccine live (oka/merck) (VARIVAX) lot # S006018, expiration date: 27-FEB-2021, and hepatitis a vaccine, inactivated (VAQTA) vial 25/0.5, lot # S002505, expiration date: 04-APR-2020 mixed together and administered subcutaneously in the left arm as prophylaxis (childhood immunizations, the child was due for both vaccines). No sterile diluent was used to reconstitute varicella virus vaccine live (oka/merck) (VARIVAX); just hepatitis a vaccine, inactivated (VAQTA). The patient's left arm was red and she received acetaminophen (TYLENOL) and a cool arm wrap for the redness. The outcome of the event was reported as recovering.   The relatedness between the event and varicella virus vaccine live (Oka/Merck) (VARIVAX) and hepatitis a vaccine, inactivated (VAQTA) was not reported.
Pt stated and showed pictures of a rash on arms and back that started 1week post dose. It responded to antihistamines but then flared up again after she stopped then.
Pt woke up day after injection with a very very painful left arm, slight redness just above elbow, not at injection site, redness increased and pain worsened over the next 2 days.  Pt reports pain and redness resolved by 12/17/03.
Pt developed an atypical headache with fatigue and dizziness, whole head pounding. Headache woke patient from sleep. Developed dyspnea, went to ER at 9am. Took acetaminophen/ibuprofen around-the-clock. Headache frequency diminished over the course of 4 weeks. Headache frequency never returned to normal.
a patient received dose one of Twinrix in 2019, dose two in 2020; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose in 2019) and Twinrix (received 2nd dose in 2020).   On an unknown date, the patient did not receive the 3rd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: a patient received dose one of Twinrix in 2019, dose two in 2020). The outcome of the incomplete course of vaccination 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 Information: GSK Receipt Date: 25-SEP-2023 The reporter could not provide exact dates of administration, lot numbers or expiration dates of Twinrix.  No additional information was provided. Till the time of reporting, the patient did not receive the 3rd dose of Twinrix, which led to incomplete course of vaccination.
This spontaneous report was received from other health professional referring to an unknown number of unspecified patients. Information regarding the patients' pertinent medical history, and drug reactions or allergies were not provided. On an unknown date starting on or after 31-JUL-2017, an unknown number of unspecified patients were administered improperly stored doses of PROQUAD lot # M043306, exp. 24-APR-2018, M044718, exp 17-MAY-2018; lot N010115, exp 24-SEP-2018). Lot information not available for properly stored sterile diluent (MERCK) used to reconstitute improperly stored PROQUAD. No adverse effect reported. The doses were stored in a temperature of -14 degree Celsius to -10 degree Celsius for 2 hours. Data logger was involved. There was no previous temperature excursion reported. No additional information provided. This case is cross-referenced with 1708USA009551 (same reporter). Sender's Comments: US-009507513-1708USA009551.
Patient woke up on 10/21/16 with a knot and redness at injection site.  Patient then developed a fever that peaked at 103.5 F.  By Saturday, patient had a red rash, swelling and a lump at injection sites.  She also had malaise and fever, sweating and chills.  She then developed a sore left hip.
pt recvd vax & had purple discoloration ( bruise on rt arm);  center firm & more sore; sensitive to touch;
Patient vomited almost immediately after receiving vaccine. She was monitored for 15 minutes. Showed no signs of allergic reaction afterwards.
30 seconds after administration of Pfizer Booster (Off Label use) vaccine patient felt lightheaded, body tremors. VS taken, HR 130, BP 148/94, O2 100%, Resp 25. Patient reports no history of anxiety, physically fit and states she did not have a reaction previously. 10 minutes later body tremors became stronger in nature. Water provided. VS: 134/92, HR 70, O2 100%, Resp 21, lightheadedness had resolved. Patient continued to be monitored in extended Observation. Repeat VS HR 64, BP 132/87, O2 100%, After another 15 minutes, patient decided to take her own Benadryl (PO) as lightheadedness began again. Patient continued to be monitored. After another 20 minutes, patient reported lightheadedness resolved and tremors stopped. Patient left the clinic independent in stable condition.
if the second dose of PROQUAD, that was administered when the patient was 17 years old; No additional AE reported.; This spontaneous report has been received from a nurse prescriber, referring a 17-year-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) subcutaneous injection (strength, dose, frequency, administration route, lot number, and expiry date were not provided) (product administered to patient of inappropriate age) indicated as prophylaxis.  No additional adverse events were reported.  This is one of several reports received from the same reporter; Sender Comments: US-009507513-2304USA000015:Original Case : 2303USA006657
Patient received Vaqta and Typhim-Vi IM in R arm at 3:05 pm. At 3:17 pm client reported feeling "tingling" on her tongue, a moment later reported difficulty swallowing. Emergency protocol initiated and first dose of epinephrine given at 3:21 pm, improvement of symptoms noted by patient following that dose. EMS called 3:27 pm.  BP 116/88 in L arm, HR 54 bpm, RR 22. Client reported return of difficulty swallowing and tingling at 3:30 pm with red/splotchy patches on arms and chest noted, client taking labored deep breaths. 2nd dose epi given at 3:31 followed benadryl at 3:35, BP 125/78 HR 94 RR 16. Redness improved and client reported ease in breathing again. 3:42 pm client began to report same tingling in mouth/tongue and stated she was having trouble swallowing again. Final dose epi given 3:45 pm, BP 136/86 HR 93 RR 15. EMS arrived 3:48 pm and client left clinic to hospital 16:02 with husband following by car.
My lymph node was swollen; Lymph node, underneath, it was my lymph node on my left thigh and under the armpit; I was feeling discomfort; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Aug2021 17:30 (Lot number: EW0165) at the age of 52 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Time:05:30 pm, Anatomical site of injection: left arm, Route of administration: intramuscular, Batch/lot number: EW0217), administration date: 04Aug2021, when the patient was 52 years old, for COVID-19 Immunisation. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "My lymph node was swollen; Lymph node, underneath, it was my lymph node on my left thigh and under the armpit; I was feeling discomfort".  Additional information: The patient stated lymph node, underneath and lymph node on  left thigh and under the armpit. That was on Friday that she was feeling discomfort and also the discomfort was more on Saturday and she just applied a warm compress to the area, monitored. She has no fever or anything like that, she was okay.  No follow-up attempts are possible. No further information is expected.
After second dose left heel hurts; pain throughout the body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Mar2021 11:00 (Lot number: ER8733) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL; SYNTHROID; LIOTHYRONIN; CYCLOBENZAPRIN. Vaccination history included: Bnt162b2 (Terrible itch and rash in butt, Lot #EN6205, 11 AM, Left arm), administration date: 08Mar2021, when the patient was 63 years old, for Covid-19 immunisation, reaction(s): "Itch", "Rash". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 29Mar2021 23:00, outcome "recovered" (30Mar2021), described as "After second dose left heel hurts"; PAIN (non-serious) with onset 29Mar2021 23:00, outcome "recovered" (30Mar2021), described as "pain throughout the body". Additional information: the patient did not take any other vaccine in four weeks. After second dose left heel hurted and it was still not better. The patient had neither problem before this. The patient did get pain throughout the body 12 hours after the second dose that went away the next day. The patient had no COVID prior vaccination and was not tested post vaccination. No known allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021486656 same pt/drug, diff events from diff dose
Golf ball sized lump at the injection site; Golf ball sized lump at the injection site that was hard; Golf ball sized lump at the injection site irritated; Golf ball sized lump at the injection site slightly sore; Golf ball sized lump at the injection site warm to the touch; persisted for 3-4 days with a low grade fever (-99 F); This spontaneous report was received from a 24 years old female patient via company representative referring to herself. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.    Approximately on 31-JUL-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route of administration, anatomical location, lot# and expiration date were not reported) for prophylaxis.  On the same day (31-JUL-2021), golf ball sized lump at the injection site that was hard, irritated, and slightly sore and warm to the touch, persisted for 3-4 days with a low grade fever (~99 Fahrenheit degrees (F)). Approximately on 06-AUG-2021 (reported as on day 6), kind of looked like a light bruise. No evidence of any other rash or anything resembling chicken pox anywhere else on the patient's body. Information about treatment given for the event, lab diagnostics/studies and medical attention was unknown. No product quality complaint (PQC) was reported. The outcome of all events was unknown.  The causality between all events and varicella virus vaccine live (oka/merck) (VARIVAX) was not provided.
This spontaneous report was received from a Nurse refers to a patient of unknown age. On an unknown date, the patient was vaccinated with VARIVAX (Merck) Lot # J012151 (Expiry: 28-SEP-2015) (0.5 ml once) subcutaneous was stored at 1C for 150 hours. No adverse effects reported. No further information provided. This case is linked to the case 1405USA000004 and 1405USA000972 (Same reporter link). Additional information has been requested.
After (10 min) receiving PNEUMOVAX, pt was seated put her coat on & then stated she did not feel well. C/O feeling sl dizziness. Sl cough, put head down to knees. Once she sat up c/o L back pain ? spasm. B/P 100/70 P - 68 R - 18. Symptoms improved within 10 min pt. then walk out of clinic, pt called about 220p reported she got home OK & felt fine. 3/7/12 states she feels much better.
Information has been received from a licensed practical nurse (LPN) concerning a 14-week-old female who on 14-JUN-2006 was vaccinated by mouth with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live.  The patient had no complaints and no adverse event was involved.  Unspecified medical attention was sought.  Additional information has been requested.