chrisvoncsefalvay/vaers-outcomes huggingface dataset:
excessive mucus; feeling feverish; little difficulty breathing; she woke up with excessive coughing; she has experienced nasal & chest congestion; she has experienced nasal & chest congestion; loss of appetite; headache; muscle aches and fatigue; muscle aches and fatigue; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 43-years-old female patient received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration on 30Apr2021 (at the age of 43-years-old) (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 via an unspecified route of administration on unknown date for covid-19 immunization. On 30Apr2021, after the second vaccine the same day caller experienced muscle aches and fatigue that lasted for about 3 days. She took Tylenol Extra Strength that seemed to help. Within the last week on an unspecified date in May 2021, she had experienced nasal & chest congestion, loss of appetite, and headache. Yesterday, 30May2021 she woke up with excessive coughing. She took cough drop & increased her fluid intake. Caller reports waking up today with congestion worse. Also patient experienced excessive mucus, feeling feverish & a little difficulty breathing on 30May2021. Around 9 am she took some Tussin for mucous & congestion relief. The caller reports the medication seems to be helping some. Therapeutic measures were taken as a result of muscle aches and fatigue, she woke up with excessive coughing and excessive mucus. The outcome of event muscle aches and fatigue was recovered on 03May2021. The outcome of the rest events was unknown.  Information about batch/Lot number has been requested.
Pt rec'd vaccines at 4pm at 6pm noted to have red areas with hives on face, arms, upper trunk. No other new exposures noted on that day.
This is a spontaneous case, initially received from a pharmacist on 30-Jan-2018, concerning a 21-year-old adult female patient. On 01-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: less than 0.5 ml, batch number: 195221, route of administration, anatomical location and expiry date: not reported). It was reported that, vaccine leaked between syringe and needle while administering to the patient (explicitly coded as syringe leak). It was stated that, there was no signs of damage on the syringe and needle used was easy point/retractable technologies. The needle was not attached tightly. As a result, partial dose was administered to the patient (less than 0.5 ml) (explicitly coded as incomplete dose administered). The defective units were reported as one and discovered during use. This report was associated with PTC (product technical complaint) with PTC reference number: 1027499. Based on the investigation performed, it was stated that, after completing the fill finish  investigation of the batch production records and manufacturing systems involved in Batch 195221, investigation determined that it was unlikely the defect identified in the complaint was the result of the manufacturing process. However, it could not be confirmed whether a defect existed in the needle or whether the user inadvertently applied pressure to the retractable needle color-coded tab during administration. As per the PTC report, it was stated that, the vaccine was leaked at Luer lock of the syringe. There were no signs of damage on the syringe, needle and packaging or no signs of leakage on the packaging. Syringe was stored in the original packaging before use and needle was tightly attached. It was reported that, no adverse effects were noted after the vaccination. The reporter assessed the events as non-serious. Non-significant case correction received 30-Jan-2018: The report was changed from 20-Jan-2018 to 30-Jan-2018 in narrative. Narrative was changed accordingly. Follow-up received from the quality assurance department on 28-Jun-2018: It was stated that, there was no signs of damage on the syringe and needle used was easy point/retractable technologies. The needle was attached tightly. After completing the fill finish investigation of the batch production records and manufacturing systems involved in Batch 195221, investigation determined that it was unlikely the defect identified in the complaint was the result of the manufacturing process. However, it could not be confirmed whether a defect existed in the needle or whether the user inadvertently applied pressure to the retractable needle color-coded tab during administration. The narrative was amended accordingly.
Fatigue; 99 F temperature; muscle pain; soreness in the arm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (soreness in the arm), FATIGUE (Fatigue), BODY TEMPERATURE INCREASED (99 F temperature) and MYALGIA (muscle pain) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included Adverse event.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness in the arm). On 20-Feb-2021, the patient experienced FATIGUE (Fatigue), BODY TEMPERATURE INCREASED (99 F temperature) and MYALGIA (muscle pain). At the time of the report, PAIN IN EXTREMITY (soreness in the arm), FATIGUE (Fatigue), BODY TEMPERATURE INCREASED (99 F temperature) and MYALGIA (muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.
Mild erythema ant/lat left thigh with 2 cm diameter nodule with mild-nod erythema/indurated mild tenderness to palpate.
Soreness in left arm injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness in left arm injection site) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021M20A) for COVID-19 vaccination.     The patient's past medical history included Fibromyalgia. Concurrent medical conditions included Immunocompromised and Chronic fatigue syndrome.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness in left arm injection site). At the time of the report, VACCINATION SITE PAIN (Soreness in left arm injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported. No concomitant medication was reported.   This case was linked to MOD-2022-473707 (Patient Link).
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On an unspecified date in March 2016 the patient was vaccinated with first dose of expired M-M-R II (expired product administered) (lot # K000997, expiry date 22-JAN-2016) 0.5 ml, intramuscularly (incorrect route of drug administration). No concomitant medications were reported. On an unknown date in March 2016 the patient was vaccinated with second dose of expired M-M-R II (expired product administered)(lot # K000997, expiry date 22-JA-2016) 0.5 ml, intramuscularly (incorrect route of drug administration). No adverse effects were reported. The action taken with the therapy with M-M-R II was unknown. The outcome of the events was unknown. There was no product quality complaint reported. Additional information has been requested.
We were on vacation, I noticed I had a painful burning rash on back, left ribcage and stomach it was extremely itchy. I went to the local urgent care to have it looked at and get medication. I was told that I had shingles. I was given valacyclovir oral medication and was advised to get lidocaine spray. I do have a few spots left on my body but mostly everything has cleared.
Information has been received from Merck Pregnancy Registry for GARDASIL from a physician concerning a 15 year old female patient who on 27-MAR-2009 was vaccinated with a first dose of GARDASIL (lot # 659655/0940X). On 27-MAY-2009 she received second dose of GARDASIL (lot # 662229/1497X). On an unspecified date the patient became pregnant. Follow up information has been received from a physician concerning the 15 year old female patient with a vaccination history that included five doses of DTaP (manufacturer unknown) on 07-FEB-1994, 07-SEP-1994, 21-JUN-1994, 30-JUN-1995, 25-AUG-1998. A dose of DTaP (Lot number C2556AA) at 12 year old 18-JUL-2006. Three doses of HIB (OMPC) (manufacturer unknown) on 07-FEB-1994, 21-JUN-1994, 30-JUN-1995. Three doses of ENGERIX-B on 18-JUL-2006 (Lot number B256AA), 29-DEC-2006 (Lot number B258AA) and on 01-MAY-2007 (Lot number B319AA). Four doses of POLIO (unspecified) (manufacturer unknown) on 07-FEB-1994, 07-APR-1994, 30-JUN-1995 and on 25-AUG-1998. Two doses of MMR (manufacturer unknown) on 30-JUN-1995 and on 25-AUG-1998. A dose of VARIVAX (Merck) (manufacturer unknown) on 25-AUG-1998. On 27-MAR-2009 the patient was vaccinated with the first dose of GARDASIL and on 27-MAY-2009 received the second dose of GARDASIL. The physician reported that the patient delivered a baby boy by c-section on 07-SEP-2009. On 07-SEP-2009 the patient was born with genetic hypospadias at 34 weeks and weight at birth of 2280 grams. The physician added that discussion with the baby's parents have been made and this condition may be corrected when the baby is 1 year of age. The physician reported that both the mother and the baby are doing well. Upon internal review genetic hypospadias was considered as genetic anomaly and delivered a baby boy by c-section to be as other important medical event. No further information is available.
Approximately 70 days post second vaccination - Skin sensitivity and pain on left side posterior neck and lower scalp, skin vesicles at same site, episodes of short-duration head/ear aches at the same location. Presumptive diagnosis of shingles on 16 Jun (75 days post vaccination 2) based on physical exam at urgent care center.  Initiated 7-day course of valacyclovir on 16 Jun Slow resolution of skin vesicles but as of today residual skin sensitivity/pain on left side posterior neck and lower scalp and recurring short duration head aches.
After receiving last injections, child looked pale in face. I (nurse) applied band-aid then child rolled eyes up and closed them. I eased child to floor and 10-15 sec later child woke up crying and asking mom what happened. I gave child orange juice and applied cool towels to face and neck. Then sat child back in chair and called supervisor - 10/8/09 8:45 AM called mother. Per mom child is much better and feel ok. MD diagnosis: Syncopal episode.
According to mom, child was cool, clammy and breathing quickly while asleep about 1-2 hours after immunizations. Difficult to arouse; staring blankly for 10-15 minutes. No seizure activity.
This spontaneous case reported by a consumer, describes the occurrence of erythematous rash (red bumps on arm) in a 26-year-old female patient who received mRNA-1273 for COVID-19 vaccination. No medical history reported. On Apr 23, 2021, patient received dose of mRNA-1273, intramuscular; 1 dosage form. On Apr 30, 2021, patient experienced erythematous rash (red bumps on arm). At the time of the report, erythematous rash (red bumps on arm) outcome: unknown. The action taken with mRNA-1273, intramuscular: unknown. No concomitant medication or treatment information reported/provided.
Immunization of Moderna Covid19 vaccine was disrupted by uncooperative patient during administration of vaccine. Patient received less than 50% of dose. Dose was repeated as per CDC guidance .  There was no adverse outcome for the patient and the parent understood we were following CDC guidance.
erythema multliforme (classic eruption) 10 days p/vax; no other etiologies
SOB started 5/3/21, got worse today at walking. advise ER - Pt was admitted to hospital because bilat PE.
Since 12/7/15 I have felt a pain in my shoulder from my 3rd Gardasil shot. I thought it would go away until 12/13/15 I felt intense pain where I could barely lift my arm or move it. It was in constant pain in every position. I woke up the next day and the pain had subsided. But now I have limited range of motion. In some directions I feel sharp pain. I did not have this at all before the shot.
This spontaneous report as received from a registered nurse refers to a 5 year old patient (gender was not reported). On 31-AUG-2015, the patient was vaccinated with a dose of improperly stored (Merck) PROQUAD lot # K020754 (dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
21x13cm redness, minimal swelling, positive warmth, non tender left thigh 2 days after Dtap given. Rx for cellulitis. Given RX Keflex 250 mg 5ml 1 tsp TID x 10 days.
Patient's 1st dose was in December. He had mild fevers. Loss of appetite, and was lethargic for the following 4 days. His 2nd dose was today and he became dizzy and fainted. He was monitored for about 20 minutes afterwards because his vitals dropped as well. He's doing better but I'm worried about his 3rd dose and whether he should have it. The HPV vaccine does not bode well with him.
I noticed a lump the size of a big marble on my collar bone on my right side. I noticed this the day 9/10 after receiving my 2nd dose of Covid Vacccine the day after my vaccine. I only noticed it because it hurt when I touched it. It felt like when you touch a bruise. When touching it the ball(lump) moved and hurt. The next day the ball 9/11 became smaller like the size of a bean and did not hurt anymore. Present day 9/24 two weeks and I still feel it but now it is the size of a pinto bean and does not hurt.
Slowly increasing pain in muscles and tendons of wrist/thumb (previous tendinitis was 10+ years ago and no change of habit accounts for this pain).   Occasional breast itchiness I have not experienced since discontinuing seasonal allergy shots 5+ years ago.  Above two symptoms feel like general increase in body inflammation.  Some minor fatigue and lymph node swelling.
focal sz; ECG abn; 1st sz episode, no past hx; hospitalized less that 48 hr; will be seen by neruologist;
Pt dizzy after IM shot @ 1200. Felt hot and tingly in legs. 1215 - Nausea, BP 143/90. 1230 - increasing dizziness and headache. 1300 - vomited x 7. 1309 - pt complained of throat pressure and increased vomiting. 50mg IM benadryl given. EMS called and Pt taken to hospital for evaluation.
Elevation of tinnitus volume, lasted two days.  Began about one hour after injection.  My hope is that data such as this can be used in tinnitus research.  I am willing to participate in a clinical trial.   Thank you.
Sore arm for 48 hours that progressively felt better.  Some nausea the same day that went away after I ate something.  Nothing else to report thus far.
Person received their first COVID-19 vaccine on 5/25/21 and it was the Moderna vaccine.  Person came back 4 weeks later and requested the Janssen vaccine.
Feeling of extreme weakness about 6 hrs. after injection, needed help to stand. Symptoms improved over the next 12 hrs. No treatment needed, was feeling much better 30 hrs after injection.
Gave vaccine in the left arm.  Needle was loose on the syringe and some of the vaccine leaked out onto patient's arm.  Telephone call to immunization nurse consultant at the Dept of Health.  Was instructed to repeat the dose as per CDC guidelines.  Another dose (.3ml) given in the right arm.
Headache had worsen, hands had numbed. Pt experienced heart palpitation. There is also a flare up on her neuropathic disease.
Delayed redness, pain and swelling left arm with perceived fever, chills and body aches
No adverse effects were noted; The patient was scheduled to receive PENTACEL, unspecified brand of "PCV 13", and and unspecified brand of a "Hep B vaccine". The patient received the PENTACEL, "HEP B" vaccine, and VAQTA instead.; a dose of VAQTA was inadvertently administered to a 9 month old.; This spontaneous report was received from a nurse referring to a 9-month-old patient of unspecified gender. Information regarding medical history and concurrent conditions was not provided. Concomitant vaccines included diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) and hepatitis B vaccine (recombinant) (manufacturer unknown).  On 08-FEB-2023, the patient was vaccinated with hepatitis A vaccine, inactivated (VAQTA) (dose, anatomical site of vaccination and route of administration were not reported; lot number W021491 has been verified to be valid, expiration date reported and established as 14-DEC-2023) for prophylaxis, instead of pneumococcal 13 valent vaccine (reported as "PCV 13", manufacturer unknown) (wrong product administered, product administered to patient of inappropriate age). No adverse effects were reported (no adverse event).
I have a small hard bump at the injection site.  It is swollen, warm, and red.  It is slightly painful to touch.
Information has been received from a registered nurse concerning a 13 year old white female who may have been vaccinated with a dose of Varivax. The nurse had no record of vaccination. However, the patient's mother stated that the child had the vaccine. On 01-APR-2006 the patient was diagnosed with chickenpox which started on 31-MAR-2006. Unspecified medical attention was sought. There was no product quality complaint involved. No other information was available. Additional information is not expected.
My son woke up with swelling and large hives around his injection site. The hives/rash spread and persisted although the swelling was reduced with Benadryl. By day 2 the hives smoothed down, but a red rash covered his thigh and remained there for 3 days.
Initially began as pain in the are and increased trying to lift the arm  Could not raise arm over head.  Progressed to numbness and tingling in arm and knot at the injection area.  Arm would become hot as well. Pain had radiated down but then progressed to radiating up to neck and Left chest area. Also experienced general aches and pains with fatigue.
5 year old female patient administered expired dose of IPOL, no AE; Initial information received on 08-Dec-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a five year old female patient who was inadvertently vaccinated with an expired dose of IPV (VERO) [IPOL] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  On 08-Dec-2020, the patient received a 0.5 ml second dose of suspect IPV (VERO) (lot P41F54 and expiry date: 07-Dec-2020) via an intramuscular route in the right arm for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  Reporter relationship: HCP (health care professional), Product used: not applicable  At the time of report, no adverse event was reported.  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.
aches 3 to 4 days; flu-like symptoms; just not feeling well; This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain (received 1st dose  on an unknown date and experienced general bosy aches, for tolerance to 1st dose, refer case US2022AMR080503).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced general body pain, influenza-like symptoms and feeling unwell. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the general body pain, influenza-like symptoms and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the general body pain, influenza-like symptoms and feeling unwell to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR080503   Additional Information: GSK Receipt Date: 13-May-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient stated that with the second dose he/she had symptoms which were worse with 3 to 4 days aches and just not feeling well. The patient stated that for him/her, it was more than worth it he/she did not want the shingles and was convinced that he/she was right! Additional Supportive Information: The follow-up would not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR080503:Same reporter
Delayed reaction after both Pfizer vaccines administered at clinic. Rash from first shot began four days later. Chest rash reignited after second shot a week after administration. New area of itchy redness in right armpit and arm. I filed Vsafe daily responses but the service ended before my symptoms erupted. PLEASE ADJUST YOUR VSAFE SYSTEM TO ACCEPT DELAYED REACTIONS.
Information has been received from a physician via Poison and Drug Center (#15-029719) referring to a 9 month old female patient. The patient was "healthy and happy" and her relevant past drug history was unknown. On an unknown date the patient was vaccinated with ROTATEQ ("standard dose", oral; lot# and expiration date not reported). The patient had no concomitant medications. On 24-JUN-2015 the patient was inadvertently vaccinated her third dose of ROTATEQ (lot# K022992, expiration date 30-JUN-2016, dose not reported, oral) at 9 month of age (inappropriate schedule of drug administration). No relevant laboratory tests were performed. As of 24-JUN-2015, it was unknown if she would continue ROTATEQ and the outcome of receiving her third dose at 9 months of age was unknown. Additional information has been requested.
moderate vertigo (Feeling of spinning, loss of balance, dizziness, lightheadedness, nausea, feeling of floating, feeling of the floor tilting), coldness and slight discoloration of hands and feet