chrisvoncsefalvay/vaers-outcomes huggingface dataset:
painful; weakish/Right arm weak-ish achy; achy/Right arm weak-ish achy; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (painful), MUSCULAR WEAKNESS (weakish/Right arm weak-ish achy), PAIN IN EXTREMITY (achy/Right arm weak-ish achy) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In March 2022, the patient experienced PAIN (painful), MUSCULAR WEAKNESS (weakish/Right arm weak-ish achy), PAIN IN EXTREMITY (achy/Right arm weak-ish achy) and NAUSEA (nausea). At the time of the report, PAIN (painful), MUSCULAR WEAKNESS (weakish/Right arm weak-ish achy), PAIN IN EXTREMITY (achy/Right arm weak-ish achy) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was reported. Patient called to see if she could take Tylenol. Patient had painful, nausea, low grade, also had right arm weakish achy.     Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 23-Mar-2022: Follow up received contains email with no new information.
Recovered COVID-19; received second in series of COVID-19 Pfizer vaccine Monday 9/27. Onset of severe abdominal pain; intractable nausea; vomiting 4 am of 9/28. Sought medical evaluation in ER on evening of 9/28 due to severity of symptoms. Noted elevated lactic acid. Treatment with fluids and antiemetic.  Symptoms resolved.
Vertigo, nausea and nystagmus while lying in bed about 43 hrs. post injection (1/16/21). Sat up and nystagmus persisted for 30-45 sec. then resolved. Nausea improved but not resolved during the day. Same events the next 2 mornings (1/17/21 & 1/18/21) with less severe nausea. Vertigo was counter-clockwise. Nystagmus was horizontal.
Redness, swelling and sorness at the vaccination site.  Treatment included cool packs, Claratin 10mg in the morning and bendaryl 25-50mg at bedtime.
No additional AE; HCP called to report an AE after an internal audit performed on 06/16/2023 identified that an expired dose of VAQTA pre-filled syringe (NDC 00006-4095-02) was inadvertently administered to a patient on 01/14/2021 by an HCP. The dose expired on 01/11/; This spontaneous report was received from a medical assistant and refers to a 12-month-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 14-JAN-2021, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) 0.5 milliliter, valid lot #S032358, expiration date: 11-JAN-2021, administered for prophylaxis (dose, frequency, strength, and route of administration were not provided). The patient did not have any adverse reactions or outcomes from the administered expired dose.
Pt recvd 3 doses of Engerix-B vax p/1st & 2nd dose pt devel rash; 3rd dose will not be given until titer is taken then a decision will be made; A pharmacist told pt was allergic to fungus & poss allergic to vax;
12 year old patient received Pfizer 5-11 year old vaccine. Parent and child notified of inappropriate dose selection. Discussed with them that patient would be receiving the Pfizer 12+ year old vaccine for second dose in 21 days. They acknowledged.
Shoulder and Arm Pain reported by pharmacy. On 12/8/2011 Saw Dr in office 2+ tender over and below injection site left deltoid. No additional work up.  12-14-2011 patient seen in office by Dr arm pain still present left shoulder/ arm diffusely swollen distal to deltoid. Prednisone pak ordered and MRI of the Humerus. Patient seen again by Dr on 01/03/2012 MRI abnormal diagnosis of Parsonage Turner Syndrome. Patient given pain meds and anti-inflammatory referred patient to Orthopedics.
Vomiting with no warning. Muscle cramps  & spasms in neck - legs & back. Headaches.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 84-year-old male patient who received SHINGRIX (batch number ML532, expiry date 13th July 2020) for prophylaxis. On 1st May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, several hours after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema and pruritus. The patient was treated with topical steroid nos (Steroid Cream). On 8th May 2018, the outcome of the injection site swelling was recovered/resolved. On an unknown date, the outcome of the injection site erythema and pruritus were recovered/resolved. The reporter considered the injection site swelling to be possibly related to SHINGRIX. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. The reporter considered the pruritus to be unlikely related to SHINGRIX. Additional details were provided as follows: The patient experienced redness at the injection site which took about a week to subside. It did not hinder him in any way. The patient also experienced itching on legs and arms, which was treated with a steroid cream prior to receipt of vaccine, so likely predated the vaccine.
lymph node swelling and pain in neck, collar bone, shoulder blade area, back of head. shoulder pain, arm numbness, pins and needles feeling in arm, headache in back of head.
I was sick for 6 days, but when I went to bed about 13 hours after the 2nd shot my left  hand and arm felt like it was asleep. That never went away thru the night and when I woke up it had gone into my right hand and arm. the next day same thing only when I went to pick up my drinking glass I dropped it because hands were actually numb. each day it it would get worse so went to the emergency room and said it was a side effect from vaccine. gave me steroids that did absolutely nothing. so I went to the doctor and they gave me Gabapentin which has done absolutely nothing as well. very difficult to work. aside from numbness and tingling there as been lots of pain and stiffness in hands , and arms become weak and give out on me. my 2nd shot was given on 08/02/2021 and nothing has changed as of today 09/14/2021. definitely need help on what to do. obviously doctors have know idea what to do. not happy about this situation and want answers!!!!!
patient received janssen Covid19 vaccine on 4/12/21. Patient then came to our facility, lied on his paperwork and verbally denied to the pharmacist  about receiving any other covid-19 vaccine.  pharmacist then gave him the first dose of the pfizer vaccine. When we were processing the vaccine paperwork, we discovered he had already gotten the Janssen vaccine back in april 2021. It was confirmed he has received the Janssen vaccine in April 2021. Pharmacist called patient and patient then confirm that he lied on the paperwork about not receiving any other vaccine despite receiving the Janssen vaccine in April 2021. At this time patient reports no medical issues after recieving the pfizer vaccine.
Shot at 1000.  Head in a vice at 10/10 pain at 2030. Body aches. Worst shoulders and neck.  Vaccine site redness pain 10/10 heat and swelling  2 inches below injection site (3 inches lower than shot) (3 inch diameter) (started day 2. Ended day 6)   Extreme fatigue x 4 days. And day 4 (mid -day) symptoms  disappeared like  nothing was ever wrong ). Except for arm
One day after injection developed 8x8 cm area of erythema, warmth, swelling and tenderness from injection site of anterior aspect of right arm over to the flexor surface. Patient treated with Keflex 750 mg BID x 7 days.
This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 83-year-old male patient who received SHINGRIX (batch number PK9BY, expiry date 19th March 2021) for prophylaxis. On 1st October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 4th October 2018, 3 days after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was recovering/resolving. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The pharmacist stated that his pharmacy gave the patient the first dose of the SHINGRIX. Approximately 3 or 4 days after receiving SHINGRIX, the patient developed a rash on his leg. He thought it was shingles so he went to see his physician. Tests were negative for shingles. The rash was now resolving.
Patient Covid + on 10/09/2021.  Patient received Moderna vaccine with 1st dose on 04/28/2021 and 2nd dose on 05/26/2021. Per ED Note:  History of Present Illness  Patient is an 85-year-old male past medical history of coronary artery disease with cardiac stents, hypertension, peripheral vascular disease and depression presenting to the emergency department via EMS transport due to generalized weakness.  Per EMS report, they arrived on scene to find male patient sitting on the toilet at home with complaint of weakness.  Patient stated at that time that he was so weak that he was unable to stand up from the toilet.  Patient has a history of skin cancer.  Patient's family is concerned that he may have a urinary tract infection and wanted him to go to the hospital for further evaluation.  Patient is extremely hard of hearing and unable to hear or answer my questions.  I spoke with the patient's wife and daughter in the waiting room and they state that the patient has been experiencing progressively worsening unable weakness and generalized decline for the past few months.  They state that he has been undergoing treatment for skin cancer and has also been experiencing severe chronic diarrhea.  He also state that yesterday he fell on concrete however deny head injury or loss of consciousness.  Unable to obtain additional HPI due to this patient's clinical condition.
Pain in L arm, unable to lift arm to put on shirt, pain is localized at the injection site, (upper deltoid muscle) possible hyperventilation after injection. Came into center 10.07.2011 md saw a localized swelling. Pt returned on 10.18.2011, no swelling but continues to be unable to left arm, unless helped.
The patient presents to ED with a 5-day history of fatigue, shortness of air, nausea, anorexia, and diarrhea.  His wife noted that his blood pressure was 77/53 which prompted ED evaluation.  On arrival he was found to be hypotensive which improved slightly with fluid bolus (2 L)  to 81/49.  Oxygen saturation was found to be 89% which improved to 96-97% after application of 2 L by nasal cannula.  He was found to be Covid-19 positive, and with acute kidney injury (creatinine 2.46).  Significant labs: Glucose 103, sodium 129, potassium 4.4, creatinine 2.46, AST 46, ALT 24, WBCs 10.74, Hgb 16.5, HCT 47.6, platelets 173.  Thus far the patient has received 2 doses of Pfizer vaccine.
I had the Moderna COVID vaccine on 01/07/21. Thirteen days later I developed a rash-type area on the arm the vaccine was administered into. I photographed it, called my PCP, and have spent the past 10 days trying to figure out how to report it. It should be easier for the general public to be able to report things regarding their health...especially adverse reactions to new products.
A red welt/rash that started small but grew in size that, after a few days, covered 80% of my arm from just below the shot location to almost my elbow. It itched quite a bit, then slowly disappeared  over the course of about 10 days.
Itchy pink rash over torso, extremities, neck. No wheeze, dyspnea, lip or tongue swelling. Our office did not give the vaccines and do not have all of the details.
Inability to sleep and racing thoughts throughout the night - treated with melatonin at 4:30 AM after not having slept. Slept from around 6 AM to around 11 AM Cramping joints and stiffness- untreated, stretched throughout the following day. They have mostly gone away Freezing extremities - treated with hot bath and blankets; even after treatment, freezing feeling and chills still persist Dull headache  - treated with 1 200mg ibuprofen at 4:30 AM, came back after ibuprofen wore off
This case was reported by a consumer via call center representative and described the occurrence of muscle pain in an adult patient who received Herpes zoster (SHINGRIX) for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced muscle pain, tiredness, and pain. The patient was treated with paracetamol (TYLENOL). On an unknown date, the outcome of the muscle pain, tiredness and pain were unknown. It was unknown if the reporter considered the muscle pain, tiredness, and pain to be related to SHINGRIX. Additional details were reported as follows: The case was reported by patient. The age at vaccination was not reported. The age group was not reported but captured adult as per vaccine indication. The patient received vaccine and experienced muscle pain, tiredness, and pain. The patient received T for pain and asked how to mitigate the muscle pain and ease the tiredness. No other information was available.
Pt broke out in a rash, (at times itchy) on trunk, back, arms & legs. Advised to take BENADRYL 25mg for itching.
This spontaneous report was received from a medical assistant regarding a 4 year old patient of unknown gender. Information on patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 31-MAR-2018, the patient was vaccinated with a dose of improperly stored VARIVAX (lot # N027002 and expiration date: 28-SEP-2019), (strength, dose and route were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown) (lot # and expiry date were not reported). It was reported that the vaccine was stored in 13 degrees Fahrenheit (F) for 100 hours. There was previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. There was no product quality complaint (PQC) reported. This is one of the many reports from the same source. Sender's Comments: US-009507513-1804USA008748: US-009507513-1809USA007363.
Patient received Flu shot 10/20/08 - was feeling tired nausea on 10/21/08, mother called and I notified Dr. on reaction. Pt wasn't running a fever and I explained to the mother on any severe reactions.
Red, swollen, elevated area measuring approximately 5cm in diameter. Warm to touch. No fever from the patient. Patient was instructed to use cold compress and Benadryl. Reaction noted 24 hours after administration of vaccine to the left arm.
On 6-27-08 AM had baseball sized hot red area painful to touch.  Went to Dr. on 6-30-08 "& had shot in hip to counteract".
Fever of up to 103.2.  Chills, severe headache, myalgias, are soreness. Treated with 400mg of ibuprofen
Information has been received from a medical assistant concerning a 15 month old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unknown date, the patient was accidentally vaccinated with an expired dose of M-M-R II (dose, strength, frequency, route of administration and anatomical location were not provided) (lot # L010488 with expiration date 26-MAR-2017), for prophylaxis. No adverse effects were reported. This is one of 2 reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA011927:
Accidentally received 3rd dose; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (Accidentally received 3rd dose) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Bone disorder (NOS) and Migraine. Concomitant products included ALENDRONATE SODIUM (FOSAMAX) for Bone disorder (NOS), SUMATRIPTAN (IMITREX [SUMATRIPTAN]) for Migraine.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (Accidentally received 3rd dose). On 26-Aug-2021, EXTRA DOSE ADMINISTERED (Accidentally received 3rd dose) had resolved.            Patient received 3rd dose of Moderna vaccine accidentally instead of receiving shingles vaccine.
This spontaneous report was received from a physician and refers to a multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (concentration, dose, route and anatomical place of vaccination were not reported) which had the following lots # of M000442 and M000442 with expirations dates of 31-MAR-2018 respectively. Which were reported because a data logger and were exposed to 31F for 124 Hours, 51.F 2 hours for 30 minutes and 28.2F for 28.25 hours. This is one of several reports from the same reporter. Additional information has been requested.
Received 2 different vaccines; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Received 2 different vaccines) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 080C21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Sputnik COVID-19 vaccine (lot I-450321) on 28-Apr-2021. Past adverse reactions to the above products included No adverse event with Sputnik COVID-19 vaccine.    On 02-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Received 2 different vaccines). On 02-Sep-2021, INTERCHANGE OF VACCINE PRODUCTS (Received 2 different vaccines) had resolved.            No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: Follow-up information included about outcome of both doses of vaccine.
The Monday morning, 05Apr21, following the vaccine, my left hand had numbness and less mobility.  More numbness in my ring finger and pinky finger than the rest of my hand and about 50% mobility.  I cannot fasten my bra as I usually do and cannot perform other daily functions without it being quite a challenge.  The numbness and mobility is the same today, 13Apr21, as on 05Apr21.  Not better and not worse.  I'm wondering if the vaccine itself caused this or if the pharmacist that administered the shot hit a nerve in my arm.
itchy rash / Rash was from upper chest to groin; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 71-year-old male patient who received Herpes zoster (Shingrix) (batch number G72Z4, expiry date 13th March 2022) for prophylaxis.   The patient's past medical history included sun spots (removed via Nitrogen by dermatologist prior to vaccine). Previously administered products included Nitrogen. Concurrent medical conditions included histamine level increased (as per dermatologist).   On 4th September 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 7th September 2020, 3 days after receiving Shingrix, the patient experienced itchy rash. The patient was treated with benadryl (nos) (Benadryl Cream). On 4th March 2021, the outcome of the itchy rash was recovered/resolved.   It was unknown if the reporter considered the itchy rash to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for himself. The patient experienced itchy rash that presented 3 to 4 days following first Shingrix shot around six months ago from the reporting date that lasted for around 3 months. The rash was from upper chest to groin and it was resolved. The patient self-treated with benadryl cream and nosema and wore light clothing. The patient was able to sleep. The patient received both Covid shots without event post Shingrix shots by months. The reported batch number was tG72Z4, which was updated as G72Z4 from sales datasheet. The reporter consented to follow-up with health care professional. Note: There was discrepancy in the reported TTO (time to onset). In event section of source document it is reported as 3 days however onset date is provided the same as vaccination date and in narrative also, it is stated adverse event occurred 3 to 4 days after vaccination. However TTO captured as precise value as per event section field.
This spontaneous report was received from a pharmacist refers to a patient of unspecified age and gender. On an unspecified date, PROQUAD (lot # unspecified, route, dose and location were unspecified), which had been stored in the refrigerator at an unspecified temperature for an unspecified amount of time, was administered to the patient instead of MMR II. No adverse events were reported. Additional information has been requested.
Initial unsolicited case received on 17 March 2015 from a consumer. A 56 year old female patient with a history of allergies to Sulfa, penicillin, IV contrast dye and elevated blood pressure was vaccinated intramuscularly on 03 December 2014 with FLUZONE QUADRIVAL, batch U5036AA, site not reported. The patient has received other unidentified flu vaccines in the past. The patient reported an immediate feeling of burning and discomfort at the injection site and burning sensation of the tongue. Since then she has also experienced burning sensation of mouth and throat and has had episodes of a rapid heart rate and slight chest pain that continues at the time of the report. The patient has been hospitalized at different hospitals four times, dates and reason not reported. The patient received the vaccination at another facility to the reporter. The patient was seen by a cardiologist, but "nothing has been found". Laboratory tests were not reported. The patient outcome is not recovered. Documents held by sender: None.
Nausea, vomiting, swelling of upper arm, severe upper arm pain, total body ache, loss of appetite, headache, insomnia, fever, chills, inability to work or perform normal daily activities for 2 days.
After receiving the vaccine  he stayed in the pharmacy for 15 minutes and said he was fine. He came back after 30 minutes complaining of rash, itchiness and difficulty breathing. He stated he had a swollen throat. Patient was administered an Epipen and was fine shortly after.
Pallor & duskiness around lips X 2, 5-10 mins each- very slightly limp - OK when mom picked baby up & he began to cry-episode approx 3 hrs /p DPT/OPV/HIB, PE in MD ofc-nl except irritability & T 100.4 (R) approx 45 min /p event.
Pt did not report until 9/4/09 when she came to another Walgreens for a flu shot. She complained of soreness on R arm, resulting from PNEUMOVAX she received on 10/22/08. She said to other pharmacist that the soreness has always been there, still havaday it hasn't gone away - still has soreness.
I have had constant headaches  all week that do not go away even with ibuprofen. I also have numbness in my face and legs and last night during sleep my arm was numb and I was not laying on it. When I went to bed last night I had severe back pain.  This has not gone away even with pain relievers.
Within 6 hours of first Covid vaccination employee experienced fever  of 101.3F, rapid heart rate of 132 and complaints of headache.  Employee has taken Ibuprofen to help with headache pain and fever.